The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth.

The parent company of digital health unicorn Everlywell Inc. is expanding its portfolio of women’s health products through the acquisition of Charleston, S.C.-based startup Natalist Inc. The purchase marks Everly Health’s third acquisition of the year following agreements to buy national clinician network PWN Health and home lab testing company Home Access Health Corp. Financial terms of all deals were not disclosed. Headquartered in Austin, Texas, Everly Health will add Natalist’s suite of reproductive products to its existing tests for menopause, fertility hormones and sexual health.

Channel Medsystems Inc. completed a fundraising round to enable the nationwide commercial launch of its Cerene cryotherapy device for treatment of heavy menstrual bleeding thanks to a $26 million investment by Innovahealth Partners LP. The investment is among the largest New York-based Innovahealth has made in any company so far and makes it Channel’s largest shareholder.

Stryker Corp. has made its second acquisition of the year, picking up Gauss Surgical Inc. – the developer of an artificial intelligence (AI) platform for real-time monitoring of blood loss during surgery. Financial terms of the deal were not disclosed. Kalamazoo, Mich.-based Stryker’s shares (NASDAQ:SYK) were trading 5% higher following the acquisition. Menlo Park, Calif.-based Gauss Surgical’s Triton AI technology aims to fill a void in maternal health by enabling early detection of hemorrhage.

A study presented this week at the European Society of Human Reproduction and Embryology (ESHRE) annual conference demonstrated that the noninvasive artificial intelligence (AI) technology developed by Aivf Ltd. can instantly differentiate between genetically normal and abnormal human embryos, increasing the likelihood of successful pregnancy for couples using in vitro fertilization.

Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.

Shenzhen Mindray Bio-Medical Electronics Co. Ltd. plans to release a couple of new imaging solutions this month as part of continued and rapid growth in its home market and globally. The first to be unveiled by the Shenzhen, China-based company is the Resona I9, its latest general imaging diagnostic ultrasound system.

It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.

Renovia Inc. closed a $17 million C-1 equity funding round led by new investor Parian Global Management. Perceptive Life Sciences, Longwood Fund, Ascension Ventures and OSF Ventures added to their existing investments in the company, which develops prescription digital therapeutics for female pelvic floor disorders.

Merck & Co. Inc. telegraphed the future focus of Organon & Co., which will spin off from the pharmaceutical giant as a public company in the first half of 2021, with an announcement of an agreement to acquire Alydia Health Inc. Alydia makes the Jada system, which treats postpartum hemorrhage.