Register checked 18 Oct 2026

"FDA cleared"? We checked.

Every health app in this directory was looked up in the official FDA register and in the EU EUDAMED database. You see what holds, what doesn't, and which tools are worth recommending to patients and clients.

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FDA and EUDAMED register check
Latest FDA activity

    Browse by care area

    See what is certified in your field, in the US, the EU and Germany.

    The directory

    Pick an area of care, search by name or condition, and open any tool for the details.

    How we verify

    Certification claims on websites and app stores are often vague or out of date. Every entry goes through the same four checks.

    1. Collect the claimWhat the company says: FDA clearance, CE marking or a German DiGA listing.
    2. Check the registersWe search the FDA 510(k), De Novo and PMA databases and the EU EUDAMED database for the product and its legal manufacturer.
    3. Record the evidencePro members get the FDA reference numbers, dates and a direct link to each FDA record, the EU class with notified body and MDR certificate, plus a note when a listing was wrong or incomplete.
    4. Re-check monthlyNew clearances move up. Claims we cannot confirm move to the watchlist.
    FDA verifiedFound in the FDA register under this product or its manufacturer.
    CE IIaFound in EUDAMED as a medical device of class IIa, IIb or III, which requires a notified body. The CE verified section lists these tools when they have no FDA clearance.
    CE I · self-declaredCE class I: the manufacturer certifies itself, without a notified body. Tools with only this CE class and no FDA clearance have their own tab, CE class I.
    EU DiGAListed in the official German DiGA directory (BfArM) and reimbursed by German statutory health insurance. "Provisional" means listed for a trial period while evidence is collected.
    WatchlistClaimed to be certified, but not found in the FDA register or in EUDAMED. Not a judgement on quality.

    Who is behind this

    Prof. Koen Kas

    Certified Health Apps is curated by Prof. Koen Kas, healthcare futurist, author and keynote speaker. He holds the NN Chair of Lifestyle Medicine and Longevity at Ghent University and is CEO of HealthSkouts.

    Koen has tracked digital health tools that make it through regulators since 2017, when he started the certified app list at HealthSkouts. He has given more than 400 keynotes on the future of healthcare and wrote the books Epic and Your Guide to Delight.

    Why this directory exists: patients, clinicians and coaches keep asking which apps they can trust. Marketing pages rarely answer that. The official registers do, so every entry here is checked against them, with the reference number to prove it.

    Koen Kas on LinkedIn ↗

    Free to browse.
    Pro when you need the proof.

    Pro gives you the evidence behind every entry, for when you need to justify a choice to a patient, a colleague or a payer.

    Free

    €0Always
    • Search all verified tools
    • FDA and CE certification status
    • Filter by area of care
    Browse the directory
    Founding members: first 50 only

    Pro

    €149first year for the first 50 founding members, then €190 per year. Or €19 per month.
    • Monthly evidence file (Excel) with every entry
    • FDA reference numbers, decision years and a direct link to each FDA record
    • EU CE class from EUDAMED, with notified body and MDR certificate
    • Verification notes: wrong company, renamed or outdated listings
    • The reason behind every watchlist entry
    • Cancel any time

    Team

    €2,500per year, excl. VAT. Up to 5 users.
    • Everything in Pro, for up to 5 named users
    • One organisation licence: annual invoice, purchase orders accepted
    • Full data export (Excel and CSV)
    • Quarterly update on what changed in FDA and CE status, for internal sharing
    Request a Team licence

    For larger organisations

    Hospitals, insurers, pharma, consultancies and employer health platforms.

    Professional Team

    €5,000per year, excl. VAT. 6 to 20 users.
    • Everything in Team, for 6 to 20 users
    • A custom shortlist for your care areas
    • Annual briefing by Prof. Koen Kas
    Plan a call

    Enterprise Intelligence

    From €10,000per year, excl. VAT. Organisation-wide.
    • Organisation-wide access rights
    • Custom categories and watchlists
    • Datasets for your own systems and analyses
    • Quarterly briefing by Prof. Koen Kas

    Start with a landscape report: seven care areas, from €295

    Plan a call

    Guides, reports and books

    Deep dives by Prof. Koen Kas: comparative guides to certified digital health solutions, and books on the future of health.

    • Cover of Prescribe with Confidence
      Whitepaper · English

      Prescribe with Confidence

      How to recommend health apps without guessing (2026)

      More than one in three health apps claiming FDA status did not check out in the FDA register. A six-page field guide for clinicians and coaches: the certification ladder, a two-minute check and eight questions to ask before you recommend an app.

      Free

      You get the PDF right away, plus our monthly update. Unsubscribe anytime. Download without signing up

    • Cover of Digital diabetes care: the certified landscape
      Landscape report · English

      Digital diabetes care: the certified landscape

      Landscape report, October 2026

      71 diabetes tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of Digital heart care: the certified landscape
      Landscape report · English

      Digital heart care: the certified landscape

      Landscape report, October 2026

      78 heart and circulation tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of Remote patient monitoring: the certified landscape
      Landscape report · English

      Remote patient monitoring: the certified landscape

      Landscape report, October 2026

      72 remote monitoring and vital signs tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of Digital mental health: the certified landscape
      Landscape report · English

      Digital mental health: the certified landscape

      Landscape report, October 2026

      49 mental health tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of Digital sleep and respiratory care: the certified landscape
      Landscape report · English

      Digital sleep and respiratory care: the certified landscape

      Landscape report, October 2026

      48 sleep and respiratory care tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of Digital neurology: the certified landscape
      Landscape report · English

      Digital neurology: the certified landscape

      Landscape report, October 2026

      46 brain and nerves tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of Digital women's health: the certified landscape
      Landscape report · English

      Digital women's health: the certified landscape

      Landscape report, October 2026

      41 women's health tools verified in the FDA register, EUDAMED and the DiGA directory: what is certified, what changed since 2025, and where the gaps are. For pharma, payers and hospitals. Free sample available.

      From €295View report
    • Cover of What the Label Doesn't Say
      eBook · English

      What the Label Doesn't Say

      The state of health app certification, 2027 edition

      What we found when we checked 306 FDA claims and the EU registers one by one. With 14 verified picks, one per care area, the trap to avoid in each, and a recommendation checklist. Includes your first month of Certified Health Apps Pro.

      €19Buy
    • Cover of Digital sleep apnea management
      Whitepaper · English

      Digital sleep apnea management

      Comparative guide to 10 certified solutions (2025)

      Obstructive sleep apnea is one of the most underdiagnosed yet highest-cost chronic conditions. This guide benchmarks 10 certified digital solutions that move OSA care from the sleep lab to the home, cutting diagnostic delays from months to days and per-patient costs by up to 60%.

      €10€18Buy
    • Cover of Certified at-home blood pressure monitoring
      Whitepaper · English

      Certified at-home blood pressure monitoring

      Six next-generation FDA or CE cleared tools

      Validated, regulated digital blood pressure monitors are changing how we measure cardiovascular health. Unlike consumer wearables, these devices are FDA or CE cleared and clinically validated, and fit both personal routines and clinical care pathways.

      €10€20Buy
    • Cover of Nooit meer ziek
      Book · Dutch

      Nooit meer ziek

      Sick No More: the Dutch-language book

      Your guide to tomorrow's healthcare: a digital, mobile, engaging, social, omics-based, quantified, attractive and local vision of personalised medicine, with pioneering ideas from start-ups and leading academic labs. The first book on the promise of digital health.

      €10Buy
    • Cover of Your guide to Delight
      Book · English

      Your guide to Delight

      From reactive sick care to proactive health

      Delight is the experience closest to magic, yet concrete. A strategy and hundreds of examples of how Delight thinking helps innovate towards proactive health, with the digital (AI, sensors, IoT) and biological (genomics) revolutions, and the digital twin as your personal health assistant.

      €15Buy
    Monthly update
    New certified tools and new guides, once a month. No spam.

    Submit or correct a tool

    Missing a certified health app, or is an entry out of date? Send it in. We check every submission against the FDA register, EUDAMED and the DiGA directory before it is listed. Submissions are free and do not guarantee a listing.

    Type of submission