Medtronic Subsidiary Pays Over $17 Million for Alleged Device Kickbacks March 14, 2019 Kickbacks include offers or payments made “in kind,” the DOJ said. Read More
FDA Clears Catalyst OrthoScience’s Uncemented Humeral Implant March 13, 2019 The implant restores joint motion in the shoulder. Read More
Boston Scientific Receives CE Mark for New Version of Anti-Stroke Implant March 13, 2019 The new implant offers customized placement. Read More
J&J Earns CE Mark for Photochromic Contact Lens March 13, 2019 The company calls the lens an “entirely new category.” Read More
CDRH Warns of Potential Medical Device Shortages Following Sterilizer’s Suspension March 13, 2019 The FDA said it doesn’t know of any device shortages yet, it stated that the sterilizer’s facility’s… Read More
Sonavex’s Blood Flow Monitor Cleared by FDA March 12, 2019 The device uses deep learning algorithms with 3D ultrasound imaging to measure a patient’s blood flow after surgery. Read More
Alcyone Lifesciences Gains Breakthrough Device Designation for ThecaFlex March 12, 2019 The device is designed for patients who cannot undergo lumbar punctures. Read More
Admedus Gains CE Mark for Collagen Bioscaffold March 12, 2019 The bioscaffold reduces the need for hemostatic agents. Read More
FDA Clears Epithelial Thickness Mapping for Cirrus Platform March 12, 2019 The device helps identify patients eligible for refractive surgery. Read More
Belluscura Scolded for Supplier Evaluations March 11, 2019 The firm also failed to properly evaluate two suppliers. Read More
FDA to Release Surgical Stapler Draft Guidance March 11, 2019 Between 2011 and 2018, medical stapes have been associated with 41,000 adverse events, the agency said. Read More
Agfa Receives 510(k) Clearance for Imaging System March 11, 2019 The software can reconstruct images in less than a minute. Read More