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 […]
Gynecological
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 […]
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. […]
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 […]
Minerva Surgical CEO retires, former Activ Surgical head Todd Usen named as replacement
Minerva Surgical (Nasdaq:UTRS) announced that it appointed Todd Usen to replace retiring President and CEO David Clapper. Clapper served as president and CEO of the abnormal uterine bleeding (AUB) treatment developer since 2011. Minerva selected Former Activ Surgical CEO Todd Usen to take over those roles and become a member of the board, effective Jan. […]
Medtronic enrolls first patients in Hugo surgical robot clinical trial
Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand URO U.S. clinical trial for the Hugo surgical robot. Dr. Michael R. Abern at Duke University Hospital (Durham, North Carolina) performed the procedure. He used the Hugo robotic-assisted surgery (RAS) system for a robotic-assisted prostatectomy procedure. “This is an exciting moment,” said Abern. […]
FDA clears RF Medical radiofrequency ablation system
RF Medical announced today that the FDA cleared its Mygen M-3004 generator and specialized electrodes, including Myoblate. The Korea-based thermal ablation system manufacturer made both products commercially available in the U.S. According to a news release, the technologies help to modernize the standard of care for minimally invasive practices. “The world’s medical device market is […]
Olympus launches power morcellator with FDA-advised changes
Olympus today announced the U.S. market launch of its Moresolution power morcellator, saying it supports the safe use of the gynecologic devices under FDA guidance. In 2020, the FDA issued final guidance on power morcellators after the devices faced questions about potentially spreading cancer. The agency recommended limiting laparoscopic power morcellation (LPM) to use with […]
Study backs FEMSelect meshless pelvic floor fixation system
FEMSelect announced positive results from a four-year prospective follow-up evaluation of its EnPlace system. Newark, Delaware-based FEMSelect designed its EnPlace system as a minimally invasive, meshless approach to pelvic floor ligament fixation. The device attaches sutures to ligaments of the pelvic floor. It represents an alternative to heavily scrutinized pelvic mesh devices. Medical investigators found […]