Industry representatives, health care providers, patients and caregivers gathered April 29-30 to discuss CDRH labeling activities and the agency’s ideas for the future.
TearScience Inc. isready to go into full-scale commercialization for a new device treatment for the most prevalent form of dry eye. In late February, the young company secured up to $70 million from HealthCare Royalty Partners to help make that happen.
Gynecologists generally have the opportunity to perform in-office procedures for three indications: abnormal uterine bleeding, permanent contraception and uterine fibroids. Hologic had supplied its 460 medical device reps in the US - the largest force in women's health - with the tools to perform two of these procedures, but couldn't offer the third piece of the puzzle, an in-office treatment for fibroids, a gap which, until now, hasn't been filled by any product on the market. Hologic is filling in the missing piece with the acquisition of privately held Interlace Medical, a start-up developing MyoSure, a minimally invasive resection device for submucosal fibroids.