Tusker Medical’s TULA Pediatric Ear Tubes Awarded Breakthrough Device Designation

Posted in Medical Device

November 26, 2019 • 2 min read

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 Reducer Featured In FOCUS Magazine

Posted in Medical Device

November 26, 2019 • 2 min read

​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...

Favorable Outcomes with TCAR vs. Carotid Endarterectomy in Patients with Carotid Artery Disease

Posted in Medical Device

November 22, 2019 • 2 min read

​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 Receives FDA Breakthrough Device Designation for WRAPSODY Endovascular Stent Graft System

Posted in Medical Device

November 21, 2019 • 2 min read

​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....