Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health emergencies and another on software assurance in computer and data processing systems for medical device production.
Staar Surgical Co. reported that its 45-day window shop period ended on Sept. 19 with no competing bids made, and it urged its shareholders to vote in favor of completing the $1.5 billion cash merger with Alcon AG.
A committee of the House of Representatives advanced a bill that if passed will give eligible breakthrough medical devices four years of Medicare coverage.
Goodpath Inc., a virtual provider of whole-person care for chronic conditions, raised $18 million in series A financing, led by Massmutual Ventures with participation from Healthy Ventures and current investors.
Iantrek Inc. reported the close of a $42 million series C financing round, which it said will facilitate the U.S. commercial launch of its Alloflo Uveo, a bio-interventional ophthalmic surgery solution targeting the lightly used uveoscleral pathway, as well as broader pipeline expansion.
Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.
Just two days after reporting the appointment of a new CEO, Instylla Inc. said it received a premarket approval from the U.S. FDA for its flagship product Embrace hydrogel embolic system. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries.
