Eko Health

The algorithms are unambiguously the product of SENSORA, and they carry their own clearances, but they are inseparable from Eko's hardware business and that is the buyer relevant fact. SENSORA analyses data captured by an Eko digital stethoscope; it is not device agnostic. The stethoscopes themselves sell as functional products without any AI, offering digitally enhanced audio, active noise cancellation, waveform display and exam storage, so there is a real non AI business underneath. That coupling is the sharpest contrast with AccurKardia, indexed here, where the algorithm is deliberately device agnostic and the model is the whole product. Same structural distinction this index draws in pathology between scanner coupled and platform independent clearances. Graded B: the AI is genuinely the differentiator and the reason a health system buys SENSORA, and it also cannot be bought on its own.

The clearest oversight disclosure on this sourcing list and one of the better ones in the index, because Eko publishes three things most vendors publish none of. First, a mandatory human gate stated plainly: physician or qualified healthcare professional review and interpretation is required for every SENSORA analysis prior to clinical use, and the software is intended to support the physician rather than serve as a sole means of diagnosis. Second, an explicit NEGATIVE scope statement, that the software does not identify arrhythmias other than atrial fibrillation, which tells a clinician what the absence of a flag does not mean. That is the disclosure most detection vendors omit and the one that prevents a false sense of coverage. Third, and unusually candid, the company states that billing under CPT 0962T requires a documented provider over read, which ties the oversight requirement to the economics rather than leaving it as guidance. A buyer cannot claim reimbursement without performing the review. Publishing the condition that constrains your own revenue is the behaviour this axis is meant to reward.

Materially more disclosed than most cleared algorithm vendors and short of the top grade only on method. Eko publishes the training basis for its low ejection fraction algorithm, more than 100,000 paired electrocardiogram and ultrasound examinations, and it publishes the resulting performance: approximately 74.7 percent sensitivity and 77.5 percent specificity. Those are honest rather than flattering numbers, meaning roughly one in four cases with reduced ejection fraction will not be flagged, and publishing them rather than a rounded accuracy figure puts Eko on this index's roster of vendors that publish the unflattering half alongside AZmed and VUNO. The company also states which signals each output derives from and what intervals are computed. Held at B because no model card, architecture description or evaluation protocol is published, and the performance disclosure is detailed for low ejection fraction but not equivalently stated for the murmur and atrial fibrillation algorithms.

Among the strongest evidence records in this index, and the only one on this sourcing list with a randomised controlled trial. Three separate publications in major journals, none of which is a vendor white paper. A randomised controlled trial spanning more than 200 NHS primary care practices was published in The Lancet and is described as the largest randomised trial of AI in cardiology conducted to date, which is the right study design for a screening tool because it tests whether earlier detection actually happens in routine practice rather than whether an algorithm scores well retrospectively. An independent clinical validation in Circulation found the structural murmur algorithm doubled sensitivity for structural heart disease compared with an analogue stethoscope, a direct head to head against the incumbent method. A Lancet Digital Health study of more than 1,000 patients addressed low ejection fraction detection in primary care specifically. Real world deployment corroborates the research: more than 100 UK clinics through the NHS and Imperial College London. The low ejection fraction algorithm was developed with Mayo Clinic and a pulmonary hypertension algorithm with Brown University Health System's Cardiovascular Institute. The one caution worth recording: several of these studies involve institutional partners who are also collaborators, which is normal in device development but means the evidence is not wholly independent of the company.

No product specific statement on patient data handling, retention, de identification or model training use was located. The platform captures and stores heart sound recordings and ECG traces tied to identified patients, and the company markets exam storage and sharing of recordings for second opinions as a feature, so retention and secondary use are live questions that nothing published addresses in either direction.

No HIPAA compliance statement or business associate agreement terms were located publicly. As an enterprise platform sold into United States health systems Eko will be operating under institutional agreements, and it also operates across the NHS where UK data protection law applies, but nothing publicly verifiable was found for either regime.

No SOC 2, HITRUST, ISO 27001 or equivalent attestation, and no trust centre or security page, was located publicly. As with other cleared device manufacturers in this index, quality system obligations under FDA regulation imply more formal engineering controls than this absence suggests, but that is a different framework from an information security attestation and nothing verifiable is published.

A decade of stacked clearances rather than a single milestone, each tied to a specific stated indication. The digital stethoscope was first cleared in 2015, followed by algorithms for structural heart murmur and atrial fibrillation, the Duo combined ECG and stethoscope device, and in 2024 the Low Ejection Fraction tool, developed in collaboration with Mayo Clinic and cleared for detecting an ejection fraction at or below 40 percent in roughly fifteen seconds during a routine examination. What lifts this to A rather than simply recording the clearances is the quality of the indication language Eko publishes alongside them: the detection thresholds are numeric, the computed intervals are named, the limitation that other arrhythmias are not identified is stated, and the requirement for professional over read before clinical use is explicit. Read the individual algorithm clearances rather than treating SENSORA as a single cleared entity, since the platform is a collection of separately cleared functions.

No fairness, subgroup or population performance disclosure was located, and the published sensitivity figure makes the gap concrete rather than theoretical. At roughly 74.7 percent sensitivity for low ejection fraction, approximately one in four affected patients will not be flagged, and the question that matters is whether those misses are distributed evenly. They plausibly are not: heart sound acquisition and ECG morphology vary with body habitus, chest wall thickness, breast tissue and comorbidity, and auscultation quality has documented variability across patient populations. No breakdown of performance by sex, body mass index, ethnicity or age is published for any of the three algorithms. This matters more than usual because of where Eko aims the product. The company explicitly positions SENSORA for underserved communities whose primary care offices lack ready access to echocardiography, which is a genuinely good use of a low cost screening tool and also means any systematic underperformance would land on exactly the population the product is meant to reach.

No electronic health record integration, standard or named platform was located. SENSORA is positioned as an enterprise platform operating within the patient intake workflow and generates results that must reach the record and, given the CPT code, the billing system, but no integration method, EHR partner or reference deployment is documented publicly. For a health system evaluating deployment at intake across many sites, how results and the required provider over read are captured in the record is a first order question with no published answer.

A hardware plus cloud platform deployed at the point of care, usable in physical and virtual settings including telehealth. No hosting provider, region, tenancy model or data residency commitment is published. The gap is worth closing given the company operates at scale in both the United States and the United Kingdom, where NHS deployment across more than 100 clinics would ordinarily carry explicit data residency requirements.

Better than most because Eko discloses the reimbursement side, which is the half of the equation that usually stays hidden. The company publishes that the AMA granted a Category III CPT code, 0962T, for its AI detection algorithms in November 2024, and states the condition attached to billing it, namely a documented provider over read. Naming the code and its condition lets a practice model the revenue side and understand the work required to claim it, and it follows the pattern this index credits in HeartSciences for naming its APC code. Held at B rather than A because no product pricing is published at any level: neither the stethoscope hardware, the SENSORA platform licence, nor whether pricing is per device, per clinician or per analysis. Note also that Category III is a temporary tracking code with no established payment rate, so a buyer should not read the code as revenue.

Deliberately narrow clinically and genuinely broad operationally. Clinical scope is cardiac detection only, covering low ejection fraction, atrial fibrillation and structural murmur, with a pulmonary hypertension algorithm in development with Brown University Health System. Operationally the reach is wider than most cleared devices manage: front line primary care is the primary setting, capture can be performed by medical assistants and nurses rather than requiring a physician, the platform supports both in person and telehealth encounters, and deployment spans enterprise United States health systems and more than 100 NHS clinics in the United Kingdom. The workflow point is the strategic one, since a screening tool that only a physician can operate does not scale to every encounter and this one is designed not to require that.