STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing that the FDA in a letter dated December 6, 2019, stated that it has determined that STAAR has...
RTI Surgical Holdings (Nasdaq: RTIX), a global surgical implant company, today announced Terry Rich has joined RTI as president of Global Spine. Rich brings to RTI decades of deep spine leadership and commercial success. The company also announced the promotion of Olivier Visa to president of Global OEM...
After a successful study which evaluated the in-office placement of tympanostomy tubes in approximately 300 children ages 6 months through 12 years old, the FDA has awarded Tusker Medical breakthrough device approval for their Tula (Tubes Under Local Anesthesia) system, which delivers tympanostomy tubes (ear tubes) to young children with recurrent ear infections, in a physician’s office and under local anesthesia....
Neovasc, Inc. (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina...
InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, today reported on updated registry study data presented at the 2019 VEITH Symposium, which was held November 19-23 in New York City....
Alphatec Holdings, Inc. (Nasdaq: ATEC), a medical device company dedicated to revolutionizing the approach to spine surgery, announced today the commercial release of the SafeOp Neural InformatiX System (“SafeOp”)...
BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in the advanced non-invasive treatment of brain disorders, today reported financial results for the quarter ended September 30, 2019, and provided an operational update....
Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the VEITHsymposium. In a headline presentation, Dr. Mahmoud Malas of the University of California...
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the Merit WRAPSODY Endovascular Stent Graft System....
Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT AV drug-coated balloon (DCB)...