Cardiovascular Systems Announces Large Randomized Trial on Coronary Atherectomy for Calcified Coronary Lesions November 3, 2016 The clinical trial consists of up to 2,000 subjects performed in up to 60 sites. Read More
Hoya Group Pentax Medical Launches HemoStat WideCup November 2, 2016 The device has a larger opening width of 5.8mm compared to the 4mm one available. Read More
CSSi LifeSciences Launches Medical Device CRO November 2, 2016 The company offers specialized regulatory and clinical services. Read More
Health Canada Approves Edwards Intuity Heart Valve November 2, 2016 The device is designed to create more time during the treatment of complex heart failure cases. Read More
FDA Grants E-QURE Approval to Initiate Clinical Trial November 2, 2016 The company was approved based as a precondition to initiating the clinical trial on the first 10 patients. Read More
ResMed Reveals AirFit N20 and AirFit F20 CPAP Masks November 1, 2016 Testing has shown the AirFit N20 fit 99 percent of patients tested. Read More
Neural Analytics Receives 510(k) Clearance for Transcranial Ultrasound System November 1, 2016 The device system is a battery-operated medical-grade tablet. Read More
Tyto Care Receives FDA Clearance November 1, 2016 TytoCare’s modular exam tools and telehealth platform enable a remote examination. Read More
Boston Scientific Puts Hold on Lotus Edge Heart Valve Launch in Europe November 1, 2016 Boston Scientific received reports that in some cases the device could not be fully locked. Read More
Surmodics Launches Serene Single-Coat Solutions October 31, 2016 Serene Single-Coat solutions allow manufacturers to leverage their legacy coating process. Read More
Onkos Surgical Receives FDA 510(k) Clearance for Eleos Limb Salvage System October 31, 2016 The Eleos system is a long-term reconstructive option for oncology patients. Read More
FDA Approves IDE for Balloon Angioplasty Clinical Study October 31, 2016 The study is designed to enroll 232 subjects at up to a total of 50 U.S. and international sites. Read More