J&J’s Ethicon Releases Harmonic HD 1000i Surgical Shears October 19, 2016 The device has a tapered jaw to enable improved precision access to tissue planes. Read More
Mylan Reaches $465M Settlement of EpiPen Misclassification Charges October 19, 2016 The settlement nearly totals the amount Medicaid and Medicare spent on the allergy treatment in 2015. Read More
Medtronic Recalls Newly Acquired HeartWare Devices October 18, 2016 HeartWare had issued two global recalls due to serious risks associated with its heart ventricular assist devices. Read More
St. Jude Medical, Abbott to Sell Portion of Vascular Closure, Electrophysiology Businesses to Terumo October 18, 2016 The purchase price is about $1.12 billion. Read More
FDA Proposes to Create Database of Class II and III Home-Use Device Labels October 18, 2016 Manufacturers often don’t keep instructions on their websites for products they are not actively marketing. Read More
Improved Cross-Manufacturer Product Quality Data Needed, MDIC Finds October 18, 2016 The report is a product of the Case for Quality Initiative. Read More
Boston Scientific Releases Resolution 360 Clip October 17, 2016 A study revealed that prophylactic clipping can reduce the risk of bleeding from 9.8 percent to 1.7 percent. Read More
Teleflex Achieves FDA Clearance for Arrow Midline with Chlorag+ard Technology October 17, 2016 The catheter is designed to minimize common midline catheter complications. Read More
Disease Rarity, Production Limit Added to Custom Device Definition October 17, 2016 The rule states that production of a custom device must be limited to no more than five units per year. Read More
Draft Guidance Outlines Procedure for Clinical Evaluation of Software as a Medical Device October 17, 2016 The draft guidance addresses stand-alone software designed to produce or extract data. Read More
BTG and Mirada Medical Achieve CE Mark for Simplicit90Y Dosimetry Software in Europe October 14, 2016 This software allows for more standardized and stable dosimetry planning. Read More
Failure to Report Design Change Lands FDA Warning for Collagen Matrix October 14, 2016 Complaints indicated that the porcine material in the syringe was difficult to eject. Read More