FDA Clears Thornhill Medical's Portable Emergency Life Support System June 8, 2017 The system has a built-in oxygen concentrator. Read More
AngioDynamics Wins FDA Clearance for Solero Microwave Tissue Ablation System June 8, 2017 The Solero MTA system is not intended for cardiac use. Read More
Zebra Wins CE Mark for Its Deep Learning Imaging Analytics Engine June 7, 2017 The device provides automated analysis of imaging data. Read More
Hologic's Genius 3D Mammography Exam Gets FDA Clearance June 7, 2017 The 3D device can detect up to 65 percent more invasive breast cancers. Read More
FDA Awards Marketing Clearance to Eko’s Heart Monitor June 7, 2017 The Duo is a handheld screening tool. Read More
FDA Clears Gore’s Preperitoneal Biomaterial Hernia Repair Device June 7, 2017 The kit includes three layers. Read More
3M’S Tegaderm CHG I.V. Gets FDA Clearance for Expanded Indication of Securement Dressing June 6, 2017 The dressing is a translucent gel pad. Read More
OrbusNeich Gains FDA Clearance for Coronary Dilatation Catheters June 6, 2017 The devices allow entry through tight lesions. Read More
Boston Scientific Wins CE Mark for the Vercise Primary Cell Deep Brain Stimulation System June 6, 2017 The device provides DBS therapy. Read More
FDA Approves Expanded Indication for Sapien 3 Artificial Heart Valve for High-Risk Patients June 6, 2017 The valve-in-valve procedure offers an alternative to repeat surgery. Read More
TGA Pulls Philips’ IntelliVue MX40 Patient Monitors June 5, 2017 The monitors are worn by patients in hospitals to record and generate alarms for heart rate, oxygen saturation and other functions. Read More
CFDA to Exempt 130 In-Vitro Tests From Clinical Trials June 5, 2017 China has historically granted few exemptions for such devices. Read More