Annalise.ai

Deep learning detection across two modalities is the entire product. The enterprise chest X-ray product detects up to 124 findings in under 20 seconds and the head CT product covers up to 130 radiological findings on non contrast studies, which is comprehensive coverage rather than the single indication approach most imaging AI takes. The company has also built a foundation model applied to report generation, positioning the same underlying models beneath both detection and drafting.

Two distinct products with different oversight postures, and buyers should not conflate them. The FDA cleared portfolio is triage and notification, flagging suspected time critical pathology and prioritizing cases within the radiology worklist so the care team treats the most critical patients first, with the radiologist reading every study. The comprehensive enterprise detection product covering 124 or 130 findings operates as clinical decision support alongside interpretation. Neither renders a diagnosis. The report generation work is the direction where oversight questions will sharpen, and no published detail describes how drafted findings are reviewed.

Training data provenance is described with unusual specificity for this category: models are stated to be trained on some of the world's largest and most diverse radiologist hand annotated datasets, and the company names hand annotation rather than leaving labeling methodology vague. A published accuracy figure exists for the head CT product, reported as a 32 percent improvement in diagnostic accuracy averaged across analyzed findings, though the comparator and study design are not detailed in the materials reviewed. Model architecture and per finding performance are not published.

Deployment scale is the strongest evidence and it is substantial: clearance in more than 40 countries with deployment in 15, accessibility to half of radiologists in Australia, and use in processing more than 35 percent of chest X-rays in England, which is national infrastructure scale rather than pilot deployment. The company also reports strong results in an independent United States healthcare AI challenge for report generation. Regulatory validation spans ten separately cleared findings. What is thinner is peer reviewed outcome evidence showing changed patient results, and the 32 percent accuracy improvement claim lacks published study detail.

No published PHI framework or data governance disclosure was located. The company operates across more than 40 regulatory jurisdictions and processes imaging at national scale in at least one health system, which makes stewardship terms a per market question.

No HIPAA or BAA commitment was located in public materials. A United States buyer working with an Australia headquartered joint venture should establish business associate terms and confirm processing location directly.

No SOC 2, HITRUST, or ISO 27001 attestation was located in the materials reviewed, and no trust center was found.

Ten FDA cleared findings in the United States, split five for chest X-ray and five for head CT, built through successive 510(k) clearances beginning February 2022 with pneumothorax triage. The chest portfolio was reported as the highest number of cleared triage findings on chest X-ray in the US market, and the first product to differentiate tension pneumothorax so sites can apply distinct triage rules to the most urgent cases, which is a genuinely useful clinical distinction rather than a marketing one. The company also received the first Breakthrough Device Designation ever granted to a radiology triage device, for obstructive hydrocephalus. Regulatory reach extends to clearance in more than 40 countries.

No formal governance framework was located, but the emphasis on large and diverse hand annotated training datasets, combined with clearance across more than 40 countries and deployment at national scale in health systems with different populations and equipment, implies validation across substantial real world variation. No published subgroup performance analysis addresses demographics or acquisition equipment directly.

Products deploy into radiology worklists and reading workflows, with triage findings flagged for prioritization inside existing worklist tooling, which is the necessary integration surface. No named PACS integrations, standards support, or platform partnerships were enumerated in the materials reviewed.

No hosting, tenancy, or data residency terms were located, which is a notable gap for a vendor operating across 40 plus jurisdictions with differing localization requirements.

No published pricing, but one materially useful reimbursement fact is public: the company holds Medicare New Technology Add on Payment status in the United States, which provides a defined reimbursement pathway and changes the return calculation for a hospital buyer. Knowing NTAP applies is more actionable than most vendors in this index offer. Product structure spans separately licensed triage and comprehensive detection products, and neither is priced publicly.

Broad on both modality and finding count. Coverage spans chest radiography at up to 124 findings and non contrast head CT at up to 130 findings, with US cleared triage across pulmonary and neurocritical indications including a suite of time sensitive stroke findings. Settings span emergency, inpatient, and outpatient reading, and geographic reach covers clearance in 40 plus countries with deployment in 15, including national scale use in a public health system. Few vendors in this index combine per modality depth with this geographic footprint.