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.

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.

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.

In March, the U.S. FDA reported a major shortage of Rhogam, the anti-D immune globulin most widely used to prevent Rh factor incompatibility in pregnancy. Without treatment, second and subsequent pregnancies can be endangered by antibodies created by the mother. With the shortage, the standard treatment of two shots for all pregnant females with Rh-negative blood can be challenging, but Billiontoone Inc.’s Unity prenatal test can eliminate the need for the immune globulin treatment in 40% of these pregnancies.

Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld.

Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.

The U.S. FDA granted Edap Tms SA breakthrough device designation for its Focal One system to treat deep infiltrating rectal endometriosis. The company believes that the Focal One high intensity focused ultrasound technology can offer relief to the thousands of women suffering from the debilitating condition.

Researchers from Oregon Health and Science University (OHSU) are seeking patent protection for a transcervical delivery device that may provide clinicians with a simple, inexpensive office-based procedure for the assessment of tubal patency or delivery of a permanent contraceptive agent to the fallopian tube.

In a potential godsend for women struggling with infertility and painful periods, Hera Biotech Inc. acquired the endometriosis diagnostic assets of Scailyte AG, consolidating the two leading tissue-based diagnostic programs for the disease. The combination of the companies’ non-surgical diagnostic options could significantly speed time to treatment for millions of women, who on average spend 10 years in search of the cause of chronic pelvic pain before being diagnosed with endometriosis.

Listening to conversations between a mother and her unborn child on the cellular level could inform how the pregnancy is going and prevent complications. Three scientific groups from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in collaboration with Wayne State University and Michigan State University, have used single-cell RNA sequencing techniques to decipher these words, identify the cellular language of these interactions in the placenta and establish a cellular atlas.