FDA Grants Great Basin’s Strep Test 510(k) Clearance April 22, 2015 The company plans to launch the assay in the second quarter of this year Read More
Medtronic Starts Valiant Mona LSA Study April 22, 2015 The endovascular device treats aortic aneurysms invading the left subclavian artery. Read More
Invivoscribe to Launch Four Diagnostic Assays Following CE Mark Approval April 21, 2015 The tests detect hematologic cancers. Read More
Cardiovascular Systems’ Smaller Diamondback 360 Wins FDA Nod April 21, 2015 The device can treat peripheral arterial disease with smaller incisions at below the knee sites. Read More
MEMS Cannula Wins FDA Clearance for Alycone Lifesciences April 21, 2015 The neurological device is designed to provide optimal biodistribution for central nervous system disorder therapies. Read More
St. Jude Medical Plans to Acquire Spinal Modulation April 20, 2015 The deal will give the devicemaker control of the Axium system for dorsal root ganglion chronic pain. Read More
Syneron Candela’s Picosecond Laser Wins FDA, Health Canada Nods April 20, 2015 The PicoWay can be used for tattoo removal or the treatment of pigmented lesions. Read More
Cardiac Assist’s Emergency Cannula Receives CE Mark April 20, 2015 Treatment using the device reduces death, disability by 31 percent when compared to the standard of care, company says. Read More
Fluxion Biosciences Launches Circulating Tumor Cell Analysis Kit April 17, 2015 The kit uses epithelial and mesenchymal markers for broader cell capture. Read More
Vascular Flow Technologies Announces Spiral Flow Arteriovenous Graft Study Results April 17, 2015 The graft demonstrated higher efficacy than the standard of care. Read More
FDA Requests Modifications for Sunshine Heart’s Counter Heart Failure Study April 17, 2015 The devicemaker plans to submit an amendment early this week. Read More
Ethicon Handed Form 483 Over Complaint Handling April 17, 2015 Surgical products maker Ethicon received a Form 483 for not properly evaluating and investigating complaints of device failures. Read More