FDA Allows Marketing of Device for Carbon Monoxide Treatment March 15, 2019 ClearMate makes the patient breathe faster to speed up the rate of carbon dioxide exiting the body. Read More
FDA Grants New Indication for Valve Repair Device March 15, 2019 The new indication is for treating patients with moderate-to-severe or severe mitral regurgitation due to diminished left heart function. Read More
HemoSonics’ Quantra QPlus System Earns De Novo Authorization March 14, 2019 The results can be used in managing critical bleeding after cardiac and orthopedic surgeries. Read More
Personal Genome Diagnostics Gains CE Mark for Plasma-Based Oncology Test March 14, 2019 The test received the FDA’s breakthrough designation in July 2018. Read More
FDA Grants Premarket Approval for BD’s Venous Stent March 14, 2019 The stent is for treatment of both post-thrombotic and non-thrombotic lesions. 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
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