Digital heart care: the certified landscape 2026
From smartwatch ECG to AI that reads coronary CT: 78 digital heart tools individually assessed against the FDA register, EUDAMED and the German DiGA directory, with a verification level for every FDA entry.
Six findings
- The wrist became a cardiology device. Six consumer wearables carry an FDA-cleared ECG feature: Apple, Samsung, Fitbit, Garmin, Withings and, since 2025, WHOOP.
- The pace is high, and it is in AI. 16 products received their own FDA decision since January 2025: 7 first authorisations and 9 updates.
- Blood pressure leaves the cuff, carefully. Aktiia (sold as Hilo) received FDA clearance for optical blood pressure monitoring in 2025, and Apple for a hypertension notification.
- Europe has momentum in software for heart failure. Several of the newest heart failure tools in our directory are European software: voice analysis (Noah Labs Ark) and remote monitoring (Seerlinq HeartCore) hold CE certificates without an FDA record, and Germany reimburses ProHerz as a permanent DiGA.
- The record often carries another name. The Kardia 12L was cleared as "Impala", ScanWatch as "Scan Monitor", the PMcardio model as "Queen of Hearts".
- Europe is less transparent than the US. Only 19 of 60 tools with an FDA record appear in EUDAMED.
Inside the report
- Executive summary and six findings
- Seven segments, one care pathway: the market map
- What changed in 2025 and 2026: 7 first authorisations, 9 updates
- Seven segment tables (Smartwatches and smartphone rhythm checks; Personal and handheld ECG; Ambulatory ECG patches and monitors; AI and point-of-care cardiac diagnostics; Digital stethoscopes and heart sounds; Blood pressure and vascular health; Heart failure, remote care and cardiac fitness) with FDA route, first and latest decision, reference numbers and verification level for every tool, plus EU class, notified body certificate evidence from EUDAMED and DiGA status
- Seven ways a heart label can mislead
- What it means for pharma, insurers, care providers and primary care
- Method, verification levels and counting rules
What the full report adds to the free directory
Our free directory shows which tools are certified. The report shows the proof, and what it means.
- Evidence for every tool. The FDA record number, whether that record names this exact product, only its product family or only related hardware, the first and latest decision, and the notified body certificate evidence visible in EUDAMED. None of this is in the directory.
- What it means. The findings, the label traps, the white spaces in the market, and what the landscape means for pharma, payers, hospitals and clinicians.
- A document you can defend. Dated, externally reviewed and citeable in a strategy or procurement file. The organisation licence adds the Excel data file and the right to share it internally.
Order the full report
The full report (PDF, 14 pages) for one reader, personalised with your name and email on every page. For your own use, not for sharing.
Buy nowThe full report without personal marking, to share across your organisation, on your intranet and in internal presentations. Plus the Excel data file with all 78 tools, their FDA and EU references and certificate details, and an updated edition after six months.
Buy nowEverything in the organisation licence, plus a one-hour briefing with Prof. Koen Kas for your team on what the landscape means for your strategy.
RequestSee all certified heart and circulation tools in the free directory