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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Women's Health

Women's Health

Fertility, maternal health, pelvic and breast health devices. 15 companies listed.

London, UK  ·  Est. 2020  ·  Series A  ·  $100M raised  ·  Submission pending

Developing Amber-UI, an adaptive neuromodulation implant that senses as well as stimulates, for mixed urinary incontinence in women. Spun out of Oxford University research.

San Francisco, CA  ·  Est. 2020  ·  Unknown

Makes a portable cryoablation device that lets nurses and community health workers treat precancerous cervical cells at the point of care in primary care clinics.

Nazareth, Israel  ·  Unknown  ·  510(k) cleared

Makes LapBox, a bag-in-bag tissue containment system for laparoscopic morcellation. Both the manual and the power versions are FDA cleared.

Atlanta, GA  ·  Est. 2022  ·  Unknown  ·  In development

Developing Maternal aRMOR, a wrist worn monitor that uses laser and camera sensing of red blood cell flow to detect postpartum hemorrhage. Won the MedTech Innovator 2025 grand prize.

Sunnyvale, CA  ·  Unknown  ·  510(k) cleared

Sells devices for office-based gynecology, including the HERizon Vista hysteroscopy platform and the Symphion tissue removal system. It distributes Porter Instrument's Nitronox Plus nitrous oxide system to US gynecology practices.

BBy
New York, NY  ·  Est. 2015  ·  Seed  ·  Not a regulated device

Makes a condensing device that turns breast milk into a shelf-stable powder for hospital NICUs, removing frozen storage and defrosting from the nursing workflow.

Boston, MA  ·  Series B  ·  $43M raised  ·  De Novo granted

Sells Clairity Breast, FDA-authorized software that estimates a woman's five-year breast cancer risk from an existing screening mammogram. Now also offered directly to patients through Everlywell.

Mountain View, CA  ·  Unknown  ·  De Novo granted

Develops the Claria System, a contained tissue removal device for minimally invasive hysterectomy, funded by NSF and NIH grants.

San Francisco, CA  ·  Est. 2016  ·  Unknown

Makes a compact automated scanner that captures a 3D ultrasound volume of the breast in about a minute, with machine learning applied to flag abnormal masses.

Minneapolis, MN  ·  Unknown  ·  510(k) cleared

Remote prenatal and postpartum monitoring. The M•care System uses the M•wrap wearable and abdominal electrodes to capture fetal and maternal heart rate at home and send it to clinicians.

Mountain View, CA  ·  Series A  ·  $28M raised

Developing a device that stabilizes and closes the cervix to retain amniotic fluid and extend pregnancy in women at risk of preterm birth.

South Portland, ME  ·  Unknown  ·  De Novo granted

Makes the Prapela SVS bassinet pad, which delivers randomized vibration to treat neonatal opioid withdrawal syndrome. Technology licensed from Harvard's Wyss Institute.

Omer, Israel  ·  Est. 2014  ·  Public  ·  De Novo granted

Pulsenmore makes a smartphone cradle that lets pregnant women perform ultrasound scans at home for remote reading by clinicians. It is listed on the Tel Aviv Stock Exchange.

San Francisco, CA  ·  Series A  ·  $45M raised  ·  PMA approved

Sells the Teal Wand, an FDA-authorized self-collection device for at-home HPV cervical cancer screening, with samples run by a partner lab.

Montpellier, France  ·  Est. 2018  ·  Series A  ·  PMA approved

Womed makes a resorbable polymer film that is placed in the uterus after hysteroscopic surgery to prevent adhesions. It also works on intrauterine drug delivery for fibroids and endometriosis.

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