Remote patient monitoring: the certified landscape 2026
Camera-based vital signs, hospital-at-home patches, smart rings and monitoring platforms: 72 tools individually assessed against the FDA register, EUDAMED and the German DiGA directory.
Six findings
- The camera became a medical device. Five software products measure pulse rate, and some also breathing rate, from a short face video, most cleared in 2025 or 2026: Faceheart, Informed Vital Core, Anura, PanopticAI and SmartSpectra.
- The pace is high. 18 products received their own FDA decision since January 2025: 7 first authorisations and 11 updates, spread over camera software, smart rings, in-ear and wrist sensors, and a smart shirt.
- Hospital at home runs on patches and watches. Continuous vital signs now come from cleared patches (Biobeat, BioButton, VitalPatch, LifeSignals), wrist devices (Corsano), an in-ear sensor (c-med alpha) and a shirt (Hexoskin).
- Platforms claim more than they hold. 8 tools have no FDA clearance we could find, most of them monitoring platforms.
- Oxygen moved to the finger, the wrist and the ring. Masimo W1, Evie, circul and RingConn hold FDA clearances for blood oxygen and pulse rate, often for spot checks rather than continuous alarms.
- Europe is less transparent than the US. Only 11 of 51 tools with an FDA record appear in EUDAMED.
Inside the report
- Executive summary and six findings
- Five segments, one data chain: the market map
- What changed in 2025 and 2026: 7 first authorisations, 11 updates
- Five segment tables (Remote monitoring platforms; Continuous wearable sensors; Pulse oximetry: watches, rings and fingertips; Camera-based and contactless vital signs; Telehealth exam kits and home measurement) 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 remote monitoring 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 72 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 remote monitoring and vital signs tools in the free directory