Hepatiq’s PHM Index Gains Expanded Clearance July 13, 2016 The index is intended to “correlate future adverse events.” Read More
Health Canada Greenlights Cynosure’s SculpSure July 13, 2016 The device is designed to treat non-invasive lipolysis of the abdomen and flanks. Read More
FDA Approves Amgen’s Repatha Pushtronex System July 13, 2016 The device delivers 420 mg of the PCSK9 inhibitor Repatha. Read More
FDA Grants Expanded Clearance to Getinge’s Sterizone VP4 Sterilizer July 12, 2016 The system uses dual-sterilants of vaporized hydrogen peroxide and ozone. Read More
Essential Medical Gains IDE Approval for Manta Clinical Study July 12, 2016 The study will assess the safety and efficacy of the vascular access closure device. Read More
BioLytical Lands CE Mark Approval for HIV Self-Test July 12, 2016 The test is an OTC version of the company’s INSTI HIV-1/HIV-2 antibody test. Read More
Alafair Biosciences’ VersaWrap Tendon Protector Wins FDA Clearance July 12, 2016 The product is “ultrathin” and “sutureless.” Read More
QT Vascular’s Chocolate Heart Drug-coated Balloon Wins CE Mark Clearance July 11, 2016 The balloon features a “nitinol-constraining structure.” Read More
St. Jude Medical’s SyncAV CRT Software Scores FDA Approval July 11, 2016 The latest addition bolsters the company’s cardiac resynchronization therapy portfolio. Read More
FDA Gives Thumbs Up to Corneal Implant July 8, 2016 The corneal implant is designed to improve near vision in patients with presbyopia. Read More
Prism’s ProteXsure System Scores FDA Clearance July 6, 2016 The system only requires one hand to operate. Read More
Luminex Gains FDA Clearance and CE-IVD Mark July 6, 2016 The system will be presented at the AACC Annual Scientific Meeting & Clinical Lab Expo. Read More