Clarius Mobile Health Corp. received U.S. FDA clearance for the Clarius OB artificial intelligence biometric measurement tool, which is designed to improve access to accurate prenatal monitoring in low-resource regions. The system automatically estimates fetal age, weight and growth intervals critical to assessing fetal health and early identification of potential issues and multiple pregnancies.

A new non-invasive device which enables women to test themselves at home for signs of the cancer-causing human papillomavirus strains in menstrual blood, has been developed with support from the Venture Builder Incubator at the University of Edinburgh.

Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.

The first patenting from San Francisco-based Ananya Health Inc. describes its development of a closed-loop cryoablation platform to freeze abnormal cells before they become cervical cancer. The company’s device achieves ablative temperatures without consumable gas, making the procedure portable, battery-powered, and ten times cheaper than traditional cryoablation.

Amber Therapeutics Ltd. has raised $100 million in a series A funding round to further develop its implantable closed-loop bioelectrical therapy to treat women suffering from mixed urinary incontinence. The financing is one of the largest series A rounds ever seen in Europe’s medical technology space and comes at a time when many med-tech companies are struggling to raise funds.

The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.

Nuvo Group Ltd. recently completed a business combination with Los Angeles Media Fund (LAMF) Global Ventures Corp, a special purpose acquisition company, and became a listed company in a bid to bring its Invu pregnancy monitoring and management platform to as many women as possible. “We are totally focused on women's health and trying to drive better outcomes through pregnancy care,” Rice Powell, CEO of Nuvo, told BioWorld.

May Health SAS closed a $25 million series B financing round to advance its Ovarian Rebalancing therapy for polycystic ovary syndrome (PCOS)-related infertility. The round brings the total funds raised by the Paris-based company to date to $35 million, May Health CEO Anne Morrisey told BioWorld.

Tiumbio Co. Ltd., of Seongnam-si, Gyeonggi-do, reported positive phase IIa top-line data on May 8 for Merigolix, its lead asset to reduce pain in female patients with moderate to severe endometriosis.

Tiumbio Co. Ltd., of Seongnam-si, Gyeonggi-do, reported positive phase IIa top-line data on May 8 for Merigolix, its lead asset to reduce pain in female patients with moderate to severe endometriosis.