The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Updated August 4, 2014 at 11:30 a.m. with comments from panel members.
The FDA’s General & Plastic Surgery Devices Advisory Panel today narrowly recommended approval for Cohera Medical‘s polyurethane-based TissuGlu adhesive for the approximation of tissue layers to bind subcutaneous dead space between the tissue planes in large flap surgical procedures, including abdominoplasty.
An FDA panel convened last week to consider the use of a controversial procedure to remove uterine fibroids failed to come to a clear decision on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees.
Scores of speakers expressed outrage before a panel of FDA experts gathered at a public meeting yesterday and today to discuss the future of laparoscopic power morcellators (LPMs), devices used to break up and extract tissue during minimally invasive gynecologic surgeries.
A panel of FDA experts today was divided on whether the federal watchdog agency should approve the AcuFocus Kamra Inlay, a 1st-of-a-kind permanent corneal implant for the improvement of near and intermediate vision in patients with presbyopia, a form of age-related far-sightedness.
An FDA advisory panel voted last week to recommend approval for Staar Surgical‘s (NSDQ:STAA) Visian Toric implantable collamer lens for myopic astigmatism, sending STAA shares up nearly 17% today.
