Digital sleep and respiratory care: the certified landscape 2026
Home sleep tests, smartwatch apnea features, digital insomnia therapy and respiratory monitoring: 48 tools individually assessed against the FDA register, EUDAMED and the German DiGA directory.
Six findings
- Sleep testing left the lab, for selected patients. Cleared home sleep apnea tests now use a single chest patch (SANSA, Onera), a finger sensor (WatchPAT, NightOwl, TipTraQ), a chin sensor (Sunrise), a forehead patch (Somfit) or a ring (the Happy Health home sleep test).
- A drug joined the pathway. In December 2024 the FDA approved tirzepatide (Zepbound) for moderate to severe obstructive sleep apnea in adults with obesity, alongside diet and exercise.
- The pace is high. 14 products received their own FDA decision since January 2025: 5 first authorisations and 9 updates, most of them in home sleep testing.
- The watch became the first filter. Samsung (De Novo 2024, version 2.0 in 2026) and Apple (2024) hold FDA authorisations for sleep apnea notifications on their watches.
- Insomnia therapy is digital first. Digital cognitive behavioural therapy for insomnia is authorised in the US (Sleepio 2024, marketed as SleepioRx; Somryst 2020) and reimbursed in Germany (somnio, somnovia, HelloBetter Schlafen).
- Europe is less transparent than the US. Only 11 of 39 tools with an FDA record appear in EUDAMED.
Inside the report
- Executive summary and six findings
- Four segments, one treatment pathway: the market map
- What changed in 2025 and 2026: 5 first authorisations, 9 updates
- Four segment tables (Home sleep testing and apnea screening; Sleep apnea therapy; Insomnia and sleep therapy; Asthma, COPD and lung monitoring) 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 sleep 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, 12 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 48 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 sleep and respiratory care tools in the free directory