Hologic announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm. Clearance makes Genius the first and only FDA-cleared digital cytology system combining deep learning-based AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells, according to a news release. Hologic’s clearance […]
Gynecological
Biorithm raises $3.5M Series A for remote maternal monitoring tech
Biorithm announced that it closed a $3.5 million Series A funding round to support its personalized, connected maternity care technology. Adaptive Capital Partners and SEEDS Capital co-led the funding round. Cambridge, Massachusetts-based Biorithm plans to use the funds to fuel its expansion in Southeast Asia and the U.S. It also plans to use the cash […]
Hologic promotes from within to fill COO spot
Hologic announced that it promoted Essex Mitchell to the role of chief operating officer, effective Jan. 1, 2024. Mitchell, 44, originally joined Hologic in September 2017 as VP of sales and commercial excellence for the GYN surgical decision. He currently serves as president of GYN surgical solutions, a post he assumed in August 2020. Mitchell […]
Philips picks up funding from Gates Foundation for AI-powered maternal health ultrasound
Philips announced today that it received a second round of funding from the Bill & Melinda Gates Foundation for its ultrasound technology. The funding goes toward accelerating the global adoption of AI algorithms on the Philips Lumify handheld ultrasound system. Philips’ system utilizes AI to simplify key measurements to identify abnormalities during pregnancy. This can […]
Cooper Companies spends $300M on some Cook Medical product lines
Cook Medical today agreed to sell some reproductive health and otolaryngology product lines to Cooper Cos., the companies announced. The purchase price was $300 million. The products in the sale represent about 2.5% of Cook Medical’s sales. Manufacturing will get transferred to Cooper Cos. over a two-year period. The news comes about three months after […]
FDA grants de novo nod to BlueWind Medical’s neuromod for urinary incontinence
BlueWind Medical announced today that the FDA granted a de novo marketing request for its Revi neuromodulation system. Park City, Utah-based BlueWind designed Revi as a tibial neuromodulation system for treating the symptoms of incontinence. It treats urgency incontinence alone or in combination with urinary urgency. De novo approval for men and women with urge […]
Cooper Companies abandons $875M Cook Medical Reproductive Health business acquisition
The FTC issued a statement announcing that it learned that the Cooper Companies terminated its planned acquisition of a Cook Medical business. In February 2022, Cook Medical signed a letter of intent to sell its Reproductive Health business to CooperCompanies. The deal totaled $875 million. Cooper agreed to pay $675 million at closing and the […]
Invo wins FDA clearance for expanded InvoCell labeling
Invo Bioscience (Nasdaq:INVO) announced that the FDA granted 510(k) clearance to expand the labeling on its InvoCell device. Sarasota, Florida-based Invo’s InvoCell indication now includes a five-day incubation period. Data supporting this clearance demonstrated improved patient outcomes for the device, which previously had a three-day incubation period. The company designed InvoCell to allow fertilization and […]
BD wants to increase education on sexually transmitted infections
Earlier this year, BD shared results from a survey of more than 1,000 U.S. women found significant discrepancies in education around sexually transmitted infections (STIs). Of these women, over 18 years old, 77% identified as knowledgeable about vaginal infections, including yeast infections. However, only 60% said they felt knowledgeable about treatment options for these infections […]
Hologic beats The Street in Q2, raises guidance
Hologic today posted second-quarter results that topped the consensus forecast despite dipping COVID-19-related sales. The Marlborough, Massachusetts-based women’s health and diagnostics company posted profits of $218.5 million. That amounts to 87¢ per share on sales of $1.03 billion for the three months ended April 1, 2023. Hologic posted a 52% bottom-line slide on a sales […]
UroMems picks up FDA STeP designation for smart implant that treats urinary incontinence
UroMems announced that it received Safer Technologies Program (STeP) designation from the FDA for its UroActive smart continence therapy. STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. STeP covers devices that […]