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THE TAPE
Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register
The Directory // Women's Health

Women's Health

Fertility, maternal health, pelvic and breast health devices. 6 companies listed.

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.

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.

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.

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.

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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