AI Health Index: Diagnostics & Genomics changes https://aihealthindex.io/categories/diagnostics-and-genomics Material product changes at Diagnostics & Genomics vendors, tracked by AI Health Index. Every entry is dated and cited to a public source. en-us Free to reuse with a visible link to aihealthindex.io. Terms: https://aihealthindex.io/use-this-data Thu, 24 Sep 2026 12:00:00 GMT 720 https://aihealthindex.io/icon-192.png AI Health Index: Diagnostics & Genomics changes https://aihealthindex.io/categories/diagnostics-and-genomics Helix launched Helix Research Workspaces, a Trusted Research Environment inside Helix Explorer built on the Databricks Data + AI platform… https://aihealthindex.io/changelog/helix aihealthindex.io:change:6ab90c10ee3c2977980e6543 Thu, 24 Sep 2026 12:00:00 GMT Product / capability Diagnostics & Genomics Helix launched Helix Research Workspaces, a Trusted Research Environment inside Helix Explorer built on the Databricks Data + AI platform, giving approved partners governed compute, storage and analysis tools over more than 550,000 GenoSphere clinicogenomic records (Exome+ data linked to 13+ years of EHR history plus claims). It ships a genomic analysis toolkit for GWAS style, PheWAS and gene burden studies, an AI coding assistant Helix describes as trained on GenoSphere, no code data browsing, project notebooks with built in data access controls and monitoring, and real time job status and compute cost tracking.

Why it matters: Pharma and health system research teams can run population scale genomic analysis inside a Helix provisioned, access controlled workspace instead of standing up their own infrastructure, which changes the deployment and data governance model for GenoSphere licensees beyond the earlier Cohort Builder.

Impact: Medium. Verification: Verified. Type: Product / capability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> The FDA Molecular and Clinical Genetics Devices Panel voted on GRAIL's Premarket Approval application for the Galleri multi cancer early… https://aihealthindex.io/changelog/grail aihealthindex.io:change:6ab90c10ee3c2977980e6541 Wed, 23 Sep 2026 12:00:00 GMT Regulatory / FDA Diagnostics & Genomics The FDA Molecular and Clinical Genetics Devices Panel voted on GRAIL's Premarket Approval application for the Galleri multi cancer early detection blood test, for screening adults aged 50 and older. The 10 voting members were unanimous on safety, voted 6 to 4 on effectiveness, and voted 7 to 2 with one abstention that benefits outweigh risks. FDA is not bound by the vote and GRAIL expects a final PMA decision in the coming months.

Why it matters: Galleri is the first multi cancer early detection test to reach a PMA panel, and approval would change its regulatory standing for payers and health systems weighing coverage and adoption. The split 6 to 4 effectiveness vote is the risk to watch before FDA decides.

Impact: High. Verification: Verified. Type: Regulatory / FDA.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Indica Labs: A Voicebrook VoiceOver PRO integration with the HALO AP platform is now available, adding voice control of case and slide navigation… https://aihealthindex.io/changelog/indica-labs aihealthindex.io:change:6ab90c10ee3c2977980e6540 Tue, 22 Sep 2026 12:00:00 GMT EHR / interoperability Digital Pathology AI Diagnostics & Genomics Clinical Trials AI A Voicebrook VoiceOver PRO integration with the HALO AP platform is now available, adding voice control of case and slide navigation (zoom, pan, annotation, tab switching) and voice ordering of stains and AI analyses. A single command pulls HALO Clinical AI biomarker results such as ER and PR percentages into the matching CAP cancer protocol checklist, and sites that report inside HALO AP can pass results through to the LIS.

Why it matters: Labs running HALO Clinical AI no longer need a pathologist to re key biomarker values into the synoptic report, which removes a transcription error point in a clinically weighted field. HALO Clinical AI remains Research Use Only in the US, so automated result capture applies to clinical reporting only where the product is cleared or marked.

Impact: Medium. Verification: Verified. Type: EHR / interoperability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> GRAIL: Nature Medicine published PATHFINDER 2, the registrational US study of Galleri, with 35,878 enrolled and 32,007 participants analyzable… https://aihealthindex.io/changelog/grail aihealthindex.io:change:6ab90c10ee3c2977980e653f Tue, 22 Sep 2026 12:00:00 GMT Clinical evidence Diagnostics & Genomics Nature Medicine published PATHFINDER 2, the registrational US study of Galleri, with 35,878 enrolled and 32,007 participants analyzable for performance. The test showed a 0.54% cancer detection rate, 60.3% positive predictive value, 99.64% specificity, 39.3% episode sensitivity for all cancers (69.8% for a 12 cancer subgroup) and 91.3% cancer signal origin accuracy. Of 35,335 safety analyzable participants, 0.6% had invasive procedures and no serious study related adverse events were reported.

Why it matters: These are the peer reviewed performance and safety figures behind the PMA, giving buyers a published US intended use benchmark for follow up workload and false positive burden. Results were first presented at ASCO in May 2026, so the change is the peer reviewed publication.

Impact: Medium. Verification: Verified. Type: Clinical evidence.

Evidence: Peer-reviewed publication

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> GRAIL: Nature Medicine published Galleri test performance from the randomized NHS-Galleri trial across three annual screening rounds in England. https://aihealthindex.io/changelog/grail aihealthindex.io:change:6ab90c10ee3c2977980e653e Tue, 22 Sep 2026 12:00:00 GMT Clinical evidence Diagnostics & Genomics Nature Medicine published Galleri test performance from the randomized NHS-Galleri trial across three annual screening rounds in England. Specificity ranged from 99.50% to 99.60% and cancer signal origin accuracy from 91.1% to 93.6%, while positive predictive value fell from 58.0% to 50.4% to 45.8% across rounds. Episode sensitivity was 26.7% to 37.2% for all cancers and 47.6% to 63.4% for 12 prespecified types.

Why it matters: This is peer reviewed randomized trial evidence in an intended use population, and the falling predictive value in later rounds bears on the cost of repeat annual screening. The data were first presented at ASCO in May 2026, so the change is the peer reviewed publication.

Impact: Medium. Verification: Verified. Type: Clinical evidence.

Evidence: Peer-reviewed publication

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> AliveCor launched KardiaACCESS, its program under the CMS ACCESS Model, the 10 year Medicare initiative for technology supported chronic… https://aihealthindex.io/changelog/alivecor aihealthindex.io:change:6aaeaddaaaa02078636c9cb1 Tue, 15 Sep 2026 12:00:00 GMT Product / capability Remote Monitoring & Chronic Care Diagnostics & Genomics AliveCor launched KardiaACCESS, its program under the CMS ACCESS Model, the 10 year Medicare initiative for technology supported chronic care. Eligible Original Medicare beneficiaries get clinician guided care and AliveCor's connected devices for managing blood pressure, diabetes and heart health, at no out of pocket cost.

Why it matters: This is AliveCor becoming a care provider under Medicare, not only a device maker. Clinicians referring patients should understand who is accountable for the outcomes ACCESS pays on, and how AliveCor's clinicians coordinate with the patient's own doctor.

Impact: Medium. Verification: Verified. Type: Product / capability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Veracyte acquired Convergent Genomics, adding the UroAmp urine tumor DNA test to its urology portfolio. https://aihealthindex.io/changelog/veracyte aihealthindex.io:change:6aaeaddaaaa02078636c9cb7 Mon, 14 Sep 2026 12:00:00 GMT Acquisition / corporate Diagnostics & Genomics Clinical Decision Support Veracyte acquired Convergent Genomics, adding the UroAmp urine tumor DNA test to its urology portfolio. Veracyte can now offer genomic testing from urine, tissue and blood across bladder cancer care.

Why it matters: A urine test can help monitor bladder cancer between cystoscopies, the procedure patients most want to avoid. Urologists should ask how UroAmp results will be reported alongside Veracyte's existing tests, and whether ordering stays the same during the integration.

Impact: Medium. Verification: Verified. Type: Acquisition / corporate.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Primaa and PathPresenter announced completion of their joint validation study of Cleo Skin, Primaa's dermatopathology AI, running inside… https://aihealthindex.io/changelog/primaa aihealthindex.io:change:6aa5b27795f1c7683c18cf6d Tue, 08 Sep 2026 12:00:00 GMT Clinical evidence Digital Pathology AI Diagnostics & Genomics Primaa and PathPresenter announced completion of their joint validation study of Cleo Skin, Primaa's dermatopathology AI, running inside PathPresenter's FDA cleared clinical viewer. The study covered a realistic case mix of melanoma, naevus, squamous cell carcinoma, basal cell carcinoma and benign lesions, and the companies report faster and more consistent diagnostic reporting when the AI populates structured reporting fields inside the viewer. Interim phase one results PathPresenter published in March reported a 25 percent reduction in analysis time and a 6 percent improvement in diagnostic accuracy with the model, with higher interobserver agreement on lesion classification.

Why it matters: The finding worth holding onto is that the gains came from the AI being inside the viewer rather than beside it, which is the deployment shape most labs still have not achieved. The evidence is vendor and partner reported, with the population and endpoints described at summary level, so treat it as a workflow study rather than a diagnostic accuracy trial until the full results are published, and ask which of the interim numbers held at completion.

Impact: Medium. Verification: Partially Verified. Type: Clinical evidence.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Lumea integrated TreatmentGPS's Alpine Path into its digital pathology platform, embedding treatment guidance into the pathology report… https://aihealthindex.io/changelog/lumea aihealthindex.io:change:6a9c312c04c538181acf1b3f Wed, 02 Sep 2026 12:00:00 GMT Product / capability Digital Pathology AI Diagnostics & Genomics Lumea integrated TreatmentGPS's Alpine Path into its digital pathology platform, embedding treatment guidance into the pathology report itself. For prostate and bladder biopsies the report now carries NCCN based risk stratification, ancillary testing recommendations and a plain language summary written for the patient.

Why it matters: This moves the pathology report from a finding to a recommendation, which is a genuine widening of what a pathologist is publishing and worth a governance conversation before it is switched on. The plain language summary is the quietly significant part, since it means the report is now written for two audiences with different tolerances for uncertainty.

Impact: Medium. Verification: Partially Verified. Type: Product / capability.

Evidence: Trade press

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> bioAffinity Technologies: bioAffinity extended CyPath Lung from early detection into surveillance of lung cancer survivors. https://aihealthindex.io/changelog/bioaffinity-technologies aihealthindex.io:change:6a9c312c04c538181acf1b39 Tue, 01 Sep 2026 12:00:00 GMT Product / capability Diagnostics & Genomics bioAffinity extended CyPath Lung from early detection into surveillance of lung cancer survivors. The noninvasive sputum test is now positioned to complement CT imaging when monitoring for recurrence and when evaluating new or changing pulmonary nodules in patients who have completed curative intent treatment.

Why it matters: Surveillance is a larger and more repetitive population than initial screening, so this is a meaningful widening of where the test can sit in a pathway. The specific job is risk stratification when imaging is equivocal, which is the moment a pulmonologist currently has to choose between watchful waiting and an invasive procedure on incomplete information.

Impact: High. Verification: Verified. Type: Product / capability.

Evidence: Regulatory filing

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Caris Life Sciences published a study in npj Precision Oncology reporting that its AI guided therapy selection predicts longer survival in… https://aihealthindex.io/changelog/caris-life-sciences aihealthindex.io:change:6a92e5ef75bbcbbe469c6ff7 Thu, 27 Aug 2026 12:00:00 GMT Clinical evidence Diagnostics & Genomics Caris Life Sciences published a study in npj Precision Oncology reporting that its AI guided therapy selection predicts longer survival in pancreatic cancer patients. Pancreatic cancer is a deliberately hard test case, with short survival and few targetable alterations, so a survival signal there is a stronger claim than the same signal in a more tractable tumor type. The work validates Caris AI Insights specifically rather than the molecular profiling platform in general.

Why it matters: This is peer reviewed and reports survival rather than a surrogate such as concordance with a tumor board or rate of actionable findings, which places it at the top of the evidence hierarchy in this category. Oncology services can cite it directly when justifying AI guided profiling to a formulary or utilization committee. The caveat buyers should carry is that predicting longer survival in a retrospective cohort is not the same as demonstrating that following the recommendation caused it, and the study design determines which of those two claims is supported.

Impact: High. Verification: Verified. Type: Clinical evidence.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Stratipath Breast received CE marking under the European Union In Vitro Diagnostic Regulation, EU 2017/746. https://aihealthindex.io/changelog/stratipath aihealthindex.io:change:6a92e5ef75bbcbbe469c6ff1 Tue, 25 Aug 2026 12:00:00 GMT Regulatory / FDA Digital Pathology AI Diagnostics & Genomics Clinical Decision Support Stratipath Breast received CE marking under the European Union In Vitro Diagnostic Regulation, EU 2017/746. IVDR is a substantially higher bar than the IVD Directive it replaced, requiring clinical evidence, demonstrated analytical validity and an ongoing post market surveillance commitment rather than largely self declared conformity. For an AI based prognostic tool this is one of the more demanding routes to European market access currently available.

Why it matters: European pathology labs and oncology departments can deploy the tool clinically rather than for research use only, which is the practical distinction that determines whether a result can inform a treatment decision. The post market surveillance obligation is worth weight in a vendor comparison, because it commits Stratipath to monitoring real world performance rather than resting on the validation study. Buyers comparing AI pathology vendors across regions should note that IVDR certification and FDA clearance are not interchangeable and cover different claims.

Impact: High. Verification: Verified. Type: Regulatory / FDA.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Tempus received FDA 510(k) clearance for Tempus ECG PH, software that reads a standard 12 lead electrocardiogram and identifies signs… https://aihealthindex.io/changelog/tempus aihealthindex.io:change:6a92e5ef75bbcbbe469c6fec Mon, 24 Aug 2026 12:00:00 GMT Regulatory / FDA Clinical Decision Support Diagnostics & Genomics RCM & Prior Auth AI Clinical Trials AI Tempus received FDA 510(k) clearance for Tempus ECG PH, software that reads a standard 12 lead electrocardiogram and identifies signs associated with pulmonary hypertension. The device does not require new hardware or a new test, since it runs against ECGs that are already being captured for other reasons. This adds to the cleared cardiovascular algorithm suite Tempus has been assembling, and pulmonary hypertension is a deliberate target because it is characteristically diagnosed late.

Why it matters: Clearance is the gate that separates a research grade algorithm from something a cardiology service can put into routine practice, and this one runs on data every hospital already has in volume. The deployment question is what happens downstream of a positive flag, because pulmonary hypertension confirmation requires right heart catheterization and a screening tool that raises referral volume without a matching diagnostic pathway creates a bottleneck rather than removing one. Ask for the sensitivity and specificity in the cleared indication and the population it was established in.

Impact: High. Verification: Verified. Type: Regulatory / FDA.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> GeneDx published results from a study at Seattle Children's supporting hospital wide adoption of rapid genomic sequencing rather than the… https://aihealthindex.io/changelog/genedx aihealthindex.io:change:6a92e5ef75bbcbbe469c6fe9 Mon, 24 Aug 2026 12:00:00 GMT Clinical evidence Diagnostics & Genomics GeneDx published results from a study at Seattle Children's supporting hospital wide adoption of rapid genomic sequencing rather than the usual narrow deployment in the NICU or a single specialty service. The study evaluates both clinical and operational impact of running rapid sequencing across a whole pediatric institution, which is the question health systems actually face when deciding how far to extend a genomics program.

Why it matters: Evidence generated at a named academic pediatric center is a stronger basis for a capital decision than vendor authored case studies, and hospital wide is a meaningfully harder claim than a single unit pilot. Buyers evaluating a genomics program should read the operational half closely, since diagnostic yield is usually the easy part and turnaround time, ordering workflow and counseling capacity are what determine whether the program survives contact with a general ward.

Impact: Medium. Verification: Verified. Type: Clinical evidence.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Paige launched an AI tool that screens 505 genes directly from H and E stained pathology slides, without requiring next generation… https://aihealthindex.io/changelog/paige aihealthindex.io:change:6a92e5ef75bbcbbe469c6fe7 Sun, 23 Aug 2026 12:00:00 GMT Product / capability Digital Pathology AI Diagnostics & Genomics Drug Discovery AI Paige launched an AI tool that screens 505 genes directly from H and E stained pathology slides, without requiring next generation sequencing as a first step. The model predicts a comprehensive genomic profile from routine morphology alone and flags potential biomarkers for follow up. Rather than replacing sequencing, it is positioned as a triage layer that decides which cases warrant the full molecular workup. Paige is applying the same foundation model approach it built for cancer detection to molecular prediction.

Why it matters: Pathology labs and oncology practices can screen for hundreds of mutations off slides they already produce, compressing the time between biopsy and a targeted therapy decision. The economic argument is sequencing avoidance: labs run the expensive molecular test on the subset the model flags rather than on everything. Buyers should ask which of the 505 genes have been validated against sequencing ground truth and at what sensitivity, because a screening tool that misses a targetable mutation carries a different risk profile than one that over refers.

Impact: High. Verification: Verified. Type: Product / capability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> GeneDx introduced Exome-to-Genome Reflex ordering within Epic Aura and other supported point-to-point EHR integrations. https://aihealthindex.io/changelog/genedx aihealthindex.io:change:6a89d007fbe75a71b1da726e Wed, 19 Aug 2026 12:00:00 GMT EHR / interoperability Diagnostics & Genomics GeneDx introduced Exome-to-Genome Reflex ordering within Epic Aura and other supported point-to-point EHR integrations. This capability allows providers to automatically trigger a genome test if the initial exome test results are negative or inconclusive.

Why it matters: This integration streamlines the diagnostic workflow for clinicians using Epic by eliminating the need to manually place secondary orders. It reduces administrative friction and can accelerate the time to a definitive genetic diagnosis for patients.

Impact: Medium. Verification: Verified. Type: EHR / interoperability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> 4baseCare launched TARGT Indiegene V2, a cancer profiling panel expanded to cover 2,206 genes. https://aihealthindex.io/changelog/4basecare aihealthindex.io:change:6a89d007fbe75a71b1da7269 Tue, 18 Aug 2026 12:00:00 GMT Product / capability Diagnostics & Genomics Clinical Decision Support Clinical Trials AI 4baseCare launched TARGT Indiegene V2, a cancer profiling panel expanded to cover 2,206 genes. The updated panel is positioned by the vendor as providing precision oncology insights tailored for diverse and historically underrepresented populations.

Why it matters: Oncologists and health systems gain access to a significantly expanded genomic panel, which the vendor positions as enabling more precise targeted therapy selection for cancer patients from diverse genetic backgrounds. Reported only in trade press so far; confirm panel specifications at source before relying on them.

Impact: Medium. Verification: Partially Verified. Type: Product / capability.

Evidence: Trade press

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Indica Labs announced version 4.3 of its HALO, HALO AI, and HALO Link platforms. https://aihealthindex.io/changelog/indica-labs aihealthindex.io:change:6a89d007fbe75a71b1da7268 Mon, 17 Aug 2026 12:00:00 GMT Product / capability Digital Pathology AI Diagnostics & Genomics Clinical Trials AI Indica Labs announced version 4.3 of its HALO, HALO AI, and HALO Link platforms. The release includes a reworked image copy system in HALO for improved workflow flexibility and new features in HALO AI that the vendor says enable more efficient model testing.

Why it matters: Pathology labs and researchers can utilize the updated image management system and enhanced model testing tools to streamline their digital pathology operations and validate AI algorithms more effectively.

Impact: Medium. Verification: Verified. Type: Product / capability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Techcyte: A retrospective clinical evaluation study published in the Journal of Clinical Microbiology validated the diagnostic performance of… https://aihealthindex.io/changelog/techcyte aihealthindex.io:change:6a808db25e3cc8842da0dc37 Wed, 12 Aug 2026 12:00:00 GMT Clinical evidence Digital Pathology AI Diagnostics & Genomics A retrospective clinical evaluation study published in the Journal of Clinical Microbiology validated the diagnostic performance of Techcyte's Human Fecal Ova & Parasite Detection Wet Mount Iodine Solution. The artificial intelligence software, used alongside operator review, achieved a 96.62% positive percent agreement and a 93.33% negative percent agreement for detecting protozoan and helminthic infections in stool specimens.

Why it matters: The published findings provide strong independent validation that the artificial intelligence screening software maintains high diagnostic agreement with traditional microscopy while streamlining laboratory workflows. For microbiology labs, this clinical evidence supports the system's utility as a complementary tool that can reduce manual screening times and help uncover additional parasitic infections.

Impact: High. Verification: Verified. Type: Clinical evidence.

Evidence: Peer-reviewed publication

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> GeneDx launched a new digital offering that enables families of children with global developmental delay, intellectual disability, or… https://aihealthindex.io/changelog/genedx aihealthindex.io:change:6a808db25e3cc8842da0dc33 Tue, 11 Aug 2026 12:00:00 GMT Product / capability Diagnostics & Genomics GeneDx launched a new digital offering that enables families of children with global developmental delay, intellectual disability, or epilepsy to initiate exome testing directly from its website. The service connects families with licensed virtual clinicians who review medical histories, order genetic testing, and deliver results without requiring an in-person visit.

Why it matters: This provides a direct-to-family acquisition channel that circumvents specialty care wait times, which can exceed a year for genetics appointments. Health systems and providers can leverage this virtual-first pathway to complement traditional care and accelerate time-to-diagnosis for pediatric patients.

Impact: Medium. Verification: Partially Verified. Type: Product / capability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Valar Labs and clinical partners published a peer-reviewed study in Urologic Oncology detailing the development and validation of an… https://aihealthindex.io/changelog/valar-labs aihealthindex.io:change:6a808db25e3cc8842da0dc31 Mon, 10 Aug 2026 12:00:00 GMT Clinical evidence Digital Pathology AI Diagnostics & Genomics Clinical Decision Support Valar Labs and clinical partners published a peer-reviewed study in Urologic Oncology detailing the development and validation of an image-only AI prognostic biomarker for muscle-invasive bladder cancer (MIBC). Built on the company's Computational Histopathology Artificial Intelligence (CHAI) platform, the model extracts features from pre-treatment H&E-stained whole slide images to risk-stratify patients for recurrence-free, cancer-specific, and overall survival.

Why it matters: Clinical evidence is critical for evaluating AI diagnostics. This validation demonstrates that Valar Labs' underlying CHAI technology can derive meaningful prognostic signals from standard, already-collected pathology slides in MIBC patients, offering oncologists an additional data point for treatment planning without requiring separate molecular tests.

Impact: Medium. Verification: Verified. Type: Clinical evidence.

Evidence: Peer-reviewed publication

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Creyos announced real-world outcomes from its deployment across more than 35 sites at Claremedica, a value-based primary care organization… https://aihealthindex.io/changelog/creyos aihealthindex.io:change:6a808db25e3cc8842da0dc2f Mon, 10 Aug 2026 12:00:00 GMT Clinical evidence Clinical Decision Support Behavioral Health AI Diagnostics & Genomics Creyos announced real-world outcomes from its deployment across more than 35 sites at Claremedica, a value-based primary care organization serving over 34,000 Medicare Advantage patients. Over a seven-month period, replacing the paper-based MMSE with Creyos' digital cognitive assessment enabled Claremedica to identify over 90% of new dementia cases at the early or mild stages while reducing average screening times from roughly 12 minutes to six minutes.

Why it matters: Value-based care buyers evaluate digital screeners on both operational efficiency and diagnostic sensitivity. This named health system outcome validates that the platform can halve administrative screening time without sacrificing clinical rigor, enabling earlier intervention and proactive care planning for Medicare Advantage populations.

Impact: High. Verification: Partially Verified. Type: Clinical evidence.

Evidence: Vendor documentation

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Proscia received a new FDA 510(k) clearance for its Concentriq AP-Dx digital pathology platform. https://aihealthindex.io/changelog/proscia aihealthindex.io:change:6a7739f386781bb15a7c68dc Thu, 06 Aug 2026 12:00:00 GMT Regulatory / FDA Digital Pathology AI Diagnostics & Genomics Clinical Trials AI Proscia received a new FDA 510(k) clearance for its Concentriq AP-Dx digital pathology platform. The clearance introduces a Predetermined Change Control Plan (PCCP), adds cloud deployment capabilities, and expands interoperability to include the Leica Aperio GT 450 DX slide scanner.

Why it matters: The inclusion of a PCCP allows laboratories to adopt future FDA-cleared scanners and displays without waiting for Proscia to submit additional 510(k) filings. The newly cleared cloud deployment option and expanded scanner compatibility also provide health systems with flexibility in how they implement and scale their digital pathology infrastructure.

Impact: High. Verification: Verified. Type: Regulatory / FDA.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Tempus announced the publication of a study in Nature Medicine demonstrating the performance of PRISM2, its multimodal slide-level… https://aihealthindex.io/changelog/tempus aihealthindex.io:change:6a7739f386781bb15a7c68cf Tue, 04 Aug 2026 12:00:00 GMT Clinical evidence Clinical Decision Support Diagnostics & Genomics RCM & Prior Auth AI Clinical Trials AI Tempus announced the publication of a study in Nature Medicine demonstrating the performance of PRISM2, its multimodal slide-level pathology foundation model developed with Microsoft. The model processes routine hematoxylin and eosin slides to predict biomarker status and patient prognosis without requiring specialized fine-tuning.

Why it matters: Clinical buyers and oncology researchers can leverage this peer-reviewed evidence to validate the diagnostic and prognostic accuracy of Tempus's pathology foundation models. The ability to extract deep biological insights from standard slides reduces the need for additional complex assays.

Impact: High. Verification: Verified. Type: Clinical evidence.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Primaa integrated its Cleo Skin AI solution with the PathPresenter Image Management System (IMS). https://aihealthindex.io/changelog/primaa aihealthindex.io:change:6a7739f386781bb15a7c68ce Tue, 04 Aug 2026 12:00:00 GMT EHR / interoperability Digital Pathology AI Diagnostics & Genomics Primaa integrated its Cleo Skin AI solution with the PathPresenter Image Management System (IMS). The integration embeds Primaa's diagnostic assistance tools for melanoma, squamous cell carcinoma, and basal cell carcinoma directly into the PathPresenter digital pathology viewer.

Why it matters: Laboratories utilizing PathPresenter can now access Primaa's dermatopathology AI without leaving their primary image management workflow. This interoperability reduces friction in adopting AI tools and improves diagnostic turnaround times for common skin cancers.

Impact: Medium. Verification: Verified. Type: EHR / interoperability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Caristo Diagnostics: The FDA granted De Novo authorization (DEN250042) for CaRi-Heart, which quantifies coronary inflammation from routine coronary CT… https://aihealthindex.io/changelog/caristo-diagnostics aihealthindex.io:change:6ab95ec98120c43419d035cd Wed, 29 Jul 2026 12:00:00 GMT Regulatory / FDA Radiology & Imaging AI Clinical Decision Support Diagnostics & Genomics The FDA granted De Novo authorization (DEN250042) for CaRi-Heart, which quantifies coronary inflammation from routine coronary CT angiography and estimates a 10 year cardiovascular mortality risk. Caristo announced it on 29 July and plans a US commercial launch in the third quarter, expanding through the fourth. It joins CaRi-Plaque, cleared in February 2025, so plaque and inflammation can be read from one scan.

Why it matters: Until July, CaRi-Heart was limited to investigational use in the US. The company has not yet published the US indication or any conditions attached to the authorization, so ask for both before using the risk estimate in care. Category III CPT codes 0992T and 0993T, effective 1 January 2026, give practices a way to code it.

Impact: High. Verification: Verified. Type: Regulatory / FDA.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Waiv released two robustified digital pathology foundation models, Phaet (based on Phikon-v2) and Mascaret (based on Midnight-12k), on… https://aihealthindex.io/changelog/owkin-dx aihealthindex.io:change:6a6e7c13d9213f7e7baf7ca1 Wed, 29 Jul 2026 12:00:00 GMT Model / architecture Digital Pathology AI Diagnostics & Genomics Clinical Decision Support Waiv released two robustified digital pathology foundation models, Phaet (based on Phikon-v2) and Mascaret (based on Midnight-12k), on Hugging Face for research use. The models were fine-tuned using a model-agnostic technique designed to remove their fragility to variations in slide scanners, laboratory procedures, and tissue staining.

Why it matters: Biopharma R&D teams and healthcare researchers can leverage these open-source foundation models to build computational pathology tools that generalize safely across multi-institutional datasets without silently losing accuracy due to site-specific technical artifacts.

Impact: Medium. Verification: Verified. Type: Model / architecture.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> PathAI released version 2.21 of its AISight Dx digital pathology platform, introducing customizable case dashboards, an AI impressions… https://aihealthindex.io/changelog/pathai aihealthindex.io:change:6a6e7c13d9213f7e7baf7ca0 Wed, 29 Jul 2026 12:00:00 GMT Product / capability Digital Pathology AI Clinical Trials AI Diagnostics & Genomics PathAI released version 2.21 of its AISight Dx digital pathology platform, introducing customizable case dashboards, an AI impressions widget, and expanded metadata support for bulk slide ingestion. The update adds support for Amazon S3 Glacier Deep Archive to move older digitized slides to cold storage, along with new slide review tools like editable linear measurements.

Why it matters: Administrators managing enterprise pathology workflows gain improved control over case prioritization and storage costs through the new dashboard and Amazon S3 Glacier archiving capabilities. The expanded metadata ingestion ensures that critical specimen and block identifiers from laboratory information systems are preserved when cases enter the digital viewer.

Impact: Medium. Verification: Partially Verified. Type: Product / capability.

Evidence: Trade press

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> Heartflow PCI Navigator entered commercial use outside of clinical trials, with The Valley Hospital becoming the first U.S. institution to… https://aihealthindex.io/changelog/heartflow aihealthindex.io:change:6a6e7c13d9213f7e7baf7ca4 Mon, 27 Jul 2026 12:00:00 GMT Product / capability Radiology & Imaging AI Clinical Decision Support Diagnostics & Genomics Heartflow PCI Navigator entered commercial use outside of clinical trials, with The Valley Hospital becoming the first U.S. institution to deploy the software. The AI-powered tool provides interventional cardiologists with a personalized 3D model detailing vessel sizing, plaque buildup, and blood flow to plan coronary angioplasty and stent placement before entering the catheterization lab.

Why it matters: This marks the commercial availability of Heartflow's percutaneous coronary intervention planning capability, expanding the platform's utility from non-invasive diagnostics into interventional cardiology. Buyers can now evaluate this tool to gain pre-procedural insights, allowing clinical teams to establish treatment strategies and select device sizes before the procedure begins.

Impact: Medium. Verification: Partially Verified. Type: Product / capability.

Evidence: Trade press

Source: AI Health Index change log. Free to reuse with a link back. Terms.

]]> HeartSciences released MyoVista Insights version 1.3 with an AI-ECG Algorithm Marketplace, making Bunkerhill Health's FDA cleared ECG-EF… https://aihealthindex.io/changelog/heartsciences aihealthindex.io:change:6a5d5f872f886615435ea2de Tue, 02 Jun 2026 12:00:00 GMT Product / capability Diagnostics & Genomics Clinical Decision Support HeartSciences released MyoVista Insights version 1.3 with an AI-ECG Algorithm Marketplace, making Bunkerhill Health's FDA cleared ECG-EF algorithm for detecting reduced left ventricular ejection fraction available through the platform. Both companies are indexed here, making this a distribution relationship between two vendors in this index: Bunkerhill developed and cleared the algorithm, HeartSciences distributes it.

Why it matters: This is a distribution event rather than a clearance, and the distinction matters. The cleared algorithm belongs to Bunkerhill; HeartSciences supplies the platform that delivers it. For a community hospital, critical access hospital, or primary care practice, that is the substantive change: a cleared AI-ECG model detecting reduced ejection fraction becomes reachable without a direct enterprise agreement with the algorithm developer, in a setting where echocardiography is often not readily available. Buyers evaluating MyoVista Insights should be clear that the AI they gain access to today is Bunkerhill's, since HeartSciences' own algorithms for impaired cardiac relaxation and low ejection fraction remain in development and unsubmitted or in pre submission. Assistive AI-ECG assessments are reimbursable under the Hospital Outpatient Prospective Payment System at APC 5734.

Impact: Medium. Verification: Verified. Type: Product / capability.

Evidence: Vendor announcement

Source: AI Health Index change log. Free to reuse with a link back. Terms.

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