Transvaginal mesh used to repair pelvic organ prolapse (POP) has long been the subject of patient complaints, regulatory investigation, lawsuits and skeptical media reports. The U.S. FDA has been slowly throttling the category since 2011, requiring makers to pull products unless they opted to submit for premarket approval (PMA) by July 2018.
Innovative approaches to weight loss have fallen flat in recent decades, even as almost 40% of U.S. adults are obese and an additional 30% are overweight. Startup Gelesis Inc. has gained an FDA clearance for the first prescription weight loss treatment in years, a hydrogel pill known as Plenity (formerly Gelesis100).
Innovative approaches to weight loss have fallen flat in recent decades, even as almost 40% of U.S. adults are obese and an additional 30% are overweight. Startup Gelesis has gained an FDA clearance for the first prescription weight-loss treatment in years, a hydrogel pill known as Plenity (formerly Gelesis100).
Investors are starting off bullish on the largest eye care device company, Alcon. In the first day of trading for the Novartis AG spinoff, in early U.S. trading the company was valued at $28.5 billion. Its share price was about $58 (NYSE:ALC), above the roughly $40 to $50 share price range that had been anticipated.
Ann Arbor, Mich.-based startup Histosonics Inc. has raised a $54 million series C round to get its Robotically Assisted Sonic Therapy (RAST) platform through regulators in U.S. and Europe, conduct further clinical testing and launch the platform. The platform is based on histotripsy, which uses sound energy to generate pressure to liquify and destroy targeted cells as a subcellular level. The technology is expected to improve treatment precision, eliminate radiation exposure and provide faster healing to patients.