December 18, 2014 by Val Kennedy
The FDA awarded priority review status to Cohera Medical’s surgical sealant Sylys because the product addresses a significant unmet medical need.
Sylys is designed to prevent anastomotic leaks in patients undergoing gastrointestinal surgery. Anastomotic leaks, between sections of surgically joined intestine, are often life-threatening and can lead to septic shock, peritonitis and multiple organ failure. About one-third of deaths following colorectal surgery are associated with anastomotic leaks, according to Cohera. Read more
December 17, 2014 by Val Kennedy
CVRx said yesterday that it won a humanitarian device exemption from the FDA for its Barostim neo legacy device, to treat drug-resistant hypertension.
The watchdog agency issues HDE approvals for devices that show promise in treating conditions that affect fewer than 4,000 Americans. The approval means that while the device’s effectiveness has yet to be determined, the agency believes its probable benefits outweigh any risks. Read more
December 18, 2014 by Mark Hollmer
Italy’s Sorin Group nailed down FDA clearance for a new surgical implant designed for use in mitral valve repair.
Sorin, a cardiac device company, obtained regulators’ signoff for its Memo3D ReChord, which is a semi-rigid annuloplasty ring. Its arrival reflects Sorin’s focus on expanding in the U.S. in a key area, Michael Darnaud, president of Sorin’s cardiac surgery business, said in prepared remarks. Read more
December 19, 2014 by Mark Hollmer
Massachusetts startup Bio2 Technologies plans a limited rollout in 2015 of its high-tech bioactive bone scaffold wedges, following the FDA’s recent 510(k) clearance of the product.
Reaching the regulatory finish line follows 4 years of research and pre-clinical testing of the company’s CLM bioactive scaffold, Bio2 said. CLM, made of bioactive glass, is resorbable and implantable and helps produce a material in the body that facilitates reconstruction and growth of new, healthy bone, Bio2 said. Read more
December 17, 2014 by MassDevice
The FDA yesterday approved a device developed by Cerus Corp. to reduce the risk of infections in blood plasma transmitted during transfusions, such as HIV, hepatitis and West Nile virus, sending company shares up 25%.
The Intercept blood system for plasma uses ultraviolet light and a chemical called amotosalen that inactivates viral pathogens in the blood. The plasma is then purified to remove the chemical and its byproducts. Read more