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 […]
Women's Health
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 […]
Minerva Surgical closes $30M financing, has new controlling stockholder
Minerva Surgical (Nasdaq:UTRS) announced today that it closed a private placement worth approximately $30 million. Santa Clara, California-based Minerva sold more than 146.6 million shares of its common stock at $0.0246 per share. Accelmed Partners led the private placement with participation by New Enterprise Associates. The financing makes Accelmed the controlling stockholder of Minerva Surgical. […]
Hologic starts the year strongly
Hologic (Nasdaq: HOLX) reported Street-beating first-quarter results, with company officials confident enough to boost full-year revenue and earnings guidance. Revenue from the women’s health and diagnostics company’s COVID-19 assays may be in decline. Plus, there are supply chain challenges related to semiconductor chips in its Breast Health business. Despite the hurdles, sales growth is strong […]
Titan Medical meets with strategic buyers and investors as surgical robot developer considers its future
Titan Medical (Nasdaq:TMDI) met with potential buyers of the surgical robotics company this week in San Francisco. The Toronto-based medical device developer has been considering the best options for investors and the company’s Enos surgical robot. Facing delisting of its stock from the Nasdaq exchange due to its low price last year, Titan Medical announced […]