FDA Grants IDE Approval to Mitralign to Conduct Study of PTVAS System September 1, 2015 The system is designed to treat tricuspid regurgitation without open heart surgery. Read More
FDA Approves NovaBone MacroFORM MIS Delivery System August 31, 2015 The system enables surgeons to directly deliver bone marrow aspirate to a graft. Read More
Great Basin Submits Staph ID/R Blood Culture Panel to FDA for Clearance August 31, 2015 The submission of the multiplex panel follows a clinical trial that met Great Basin’s objectives. Read More
FDA Clears Bovie’s New J-Plasma Pistol Grip Configurations August 31, 2015 The new configurations include lengths of 15 cm, 33 cm and 45 cm. Read More
FDA Clears MagVenture's MagVita TMS Therapy System August 28, 2015 The system aims to treat depression in adults by stimulating neural tissue. Read More
Veritas Receives CE Mark Approval for Hereditary Breast and Ovarian Cancer Screening Test August 26, 2015 The test sequences the BRCA1 and BRCA2 genes using proprietary gene-targeting technology. Read More
HealthMyne Secures 510(k) Clearance from FDA for Imaging Informatics Platform August 26, 2015 The tools can increase radiologist efficiency by automating both data capture and structured report. Read More
St. Jude Medical Receives CE Mark Approval for MRI Conditional Labeling of Prodigy MRI Chronic Pain System August 25, 2015 System will become the market’s smallest MR-conditional rechargeable implantable pulse generator. Read More
BSI Approves Micell’s MiStent SES for Full-Scale Manufacturing August 24, 2015 Surgical Technologies will be the primary contract manufacturer of the system Read More
FDA Approves Boston Scientific’s Stents Platform August 20, 2015 Designs use materials that don’t disrupt MRI resolution and clarity. Read More
FDA Grants 510(k) Clearance to Tyber for Osteotomy Wedge Systems August 20, 2015 TyWedge system allows for ‘direct visualization of the healing process’ of the foot. Read More
Aurora Spine Receives CE Mark Approval for Titanium Coated Spinal Implants August 19, 2015 Implants are designed to support the entire spine from cervical to lumbar regions. Read More