Orthogrid Systems Inc., of Salt Lake City, has received a green light from the U.S. FDA for the latest application on its intraoperable PhantomMSK platform, this one for use in orthopedic trauma cases. The new PhantomMSK Trauma application, which Orthogrid plans to formally roll out next spring, joins currently available applications for total hip and hip preservation. The Trauma application is an orthopedic surgical software that helps surgeons achieve and confirm the alignment of bone fractures and improves intraoperative efficiency via artificial intelligence-trained and augmented reality-based decision support and assistance for the placement of surgical instruments. Read More
The mechanical removal of clots from the brain has become increasingly standard in ischemic stroke cases. Last year, the American Heart Association/American Stroke Association guidelines expanded the recommended window for its use up to 24 hours an event. Aspiration-based device stroke treatment startup Imperative Care Inc. has now raised an $85 million series C round to back the marketing of two recently cleared products on this front. Read More
BEIJING – Chinese transcatheter heart valve developer Venus Medtech (Hangzhou) Inc. on Tuesday saw its share prices jump around 20% on its debut on the Hong Kong Stock Exchange (HKEX), an excellent start for a prerevenue med-tech IPO. Read More
The FDA has lost a product jurisdiction case in DC district court to Genus Medical Technologies LLC over its barium sulfate contrast agent. The judge in the case ruled that the agency violated the Administrative Procedures Act in ruling that the product is a drug, but the FDA will have another crack at the matter as the application for the product has been remanded to the FDA. Read More
TORONTO – Synaptive Medical Inc. has completed the first round of a new preferred equity investment totaling $25 million led by Guelph-Ontario-based Linamar Corp., which also entered into a manufacturing agreement with Synaptive, and Calgary’s Audible Capital Corp. Read More
ORLANDO, Fla. – Two preclinical presentations at the 61st American Society of Hematology (ASH) annual meeting could pave the way for using hematopoietic stem cell transplants (HSCT) in patients who are currently too sick to tolerate the procedure, as well as in indications where its toxicities preclude its use. Read More
