Digital women's health: the certified landscape 2026
Digital contraception, fertility, home pregnancy monitoring, pelvic health and menopause therapy: 41 tools individually assessed against the FDA register, EUDAMED and the German DiGA directory.
Six findings
- Contraception became software. Natural Cycles (De Novo 2018, latest clearance 2026) and Clue Birth Control (2021) are cleared in the US as contraceptives.
- Pregnancy care is moving home. Home ultrasound read remotely by a physician (Pulsenmore ES, 2025) and remote maternal and fetal heart rate monitoring (Mcare, 2026, launch expected 2027; INVU) are authorised in the US for narrowly defined uses.
- Germany reimburses specific digital therapies. 7 tools are listed as DiGA, each for a defined indication: therapy for endometriosis, period pain, PMS, menopause, vaginismus and stress incontinence.
- Fertility marketing outruns certification. For 5 tools we found no FDA clearance.
- The pace is the slowest of our landscapes. Only 4 products received their own FDA decision since January 2025 (3 new, 1 update).
- Labels mislead, and Europe is less transparent. One tool is authorised only at family level (AirStrip OB) and 2 only through related hardware, including Daye, whose clearance covers the tampon, not the diagnostic test.
Inside the report
- Executive summary and six findings
- Four segments, one life course: the market map
- What changed in 2025 and 2026: 3 first authorisations, 1 update
- Four segment tables (Cycle, contraception and fertility; Pregnancy, birth and early feeding; Pelvic floor and continence; Menstruation, menopause and gynaecology) 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 women's health 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, 11 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 41 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 women's health tools in the free directory