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 […]
Women's Health
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 turns to Eagles rookie Kelee Ringo and his mom to raise mammograms awareness
Hologic (Nasdaq:HOLX) today announced a new partnership with recently drafted NFL quarterback Kelee Ringo and his mother. The partnership with Ringo and his mother, breast cancer survivor Tralee Hale, aims to provide education around breast health. That includes the importance of prioritizing annual mammograms and other key health screenings. Last month, the Philadelphia Eagles drafted […]
Shockwave Medical launches new coronary IVL catheter
Shockwave Medical (Nasdaq:SWAV) today announced full commercial availability for its C2+ coronary intravascular lithotripsy (IVL) catheter. The company designed its C2+ coronary IVL catheter to treat severely calcified coronary artery disease using pulsatile sonic pressure. Santa Clara, California-based Shockwave, which has been subject to recent acquisition speculation, launched the catheter in select international markets. Shockwave C2+ is […]
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 […]
Innoblative Designs wins FDA breakthrough nod for ablation device
Innoblative Designs announced today that it received FDA breakthrough device designation for its SIRA RFA electrosurgical device. Chicago-based Innoblative Designs designed SIRA for use in breast cancer patients undergoing BCS (lumpectomy). The company plans to present data supporting its breakthrough nod this week. It’s presenting at the Annual Meeting for The American Society of Breast […]
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 […]
Minerva Surgical names Kaile Zagger chief commercial officer
Women’s health company Minerva Surgical (Nasdaq:UTRS) announced that it appointed Kaile Zagger as its new chief commercial officer. Zagger’s role includes helping to guide the strategic growth of the company as it advances in the women’s healthcare space. “We are excited to have Kaile as our new Chief Commercial Officer for her proven track record […]
BD wins FDA clearance for high-throughput infectious vaginitis diagnostic
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Vaginal Panel diagnostic on the COR system. The comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis. It uses the BD COR, the company’s high-throughput molecular diagnostic platform for large laboratories. Franklin Lakes, New Jersey-based BD originally received marketing […]
FDA approves BD HPV assay for use with Hologic ThinPrep Pap test
BD (NYSE:BDX) announced today that it received FDA approval for its Onclarity HPV assay for use with the ThinPrep Pap test. The ThinPrep Pap test, developed by Hologic (Nasaq:HOLX), offers Pap and HPV testing from one vial. It accompanies the BD SurePath liquid-based Pap test vial as the most commonly used vials by labs in […]
Hologic NovaSure V5 endometrial ablation device wins European, Canadian approval
Hologic (Nasdaq:HOLX) announced today that Canadian and European officials approved its NovaSure V5 global endometrial ablation (GEA) device. Marlborough, Massachusetts-based Hologic designed the device to treat a wide range of cervical and uterine anatomies. It offers treatment for abnormal uterine bleeding. In a news release, Hologic cites 97% patient satisfaction with NovaSure. The device also […]