By including so many healthcare-related features in its much-anticipated iWatch, Apple is apparently discovering what established medical device companies have known for a long time: The FDA’s ways make the timetable for releasing a ...
Tags: Apple's iWatch, FDA
Will Google ever be a healthcare company? The answer to that question appears to be "not really," based on the tenor of a recent interview between Larry Page and Sergey Brin and investor Vinod Khosla. In that conversation, Khosla hinted ...
In a development that is being hailed as a significant milestone in the field of in vitro fertilization, Auxogyn Inc. (Menlo Park, CA) has announced that its Eeva System test has received clearance from the FDA. The test is the first ...
Tags: Certification, Service, Health, Medicine, FDA
Edwards' Sapien XT transcatheter aortic heart valve (Courtesy Edwards Lifesciences) Edwards Lifesciences Corp. (Irvine, CA) has announced both the FDA approval and the U.S. launch of its next-generation Sapien XT transcatheter aortic ...
Tags: Health, Medicine, heart valve
FDA's Circulatory System Devices Advisory Panel has submitted a unanimous approval recommendation for C.R. Bard's Lutonix Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) catheter. If FDA follows the recommendations ...
Tags: Health, Medicine, FDA, Certification
As part of the ongoing process begun by the 2012 Medical Device User Fee Amendments (MDUFA III),FDA has released its Implementation Plan for Priority Recommendations. This plan is intended to improve the efficiency of the device submission ...
AccessClosure's Mynx Grip extravascular closure device (Courtesy AccessClosure Inc.) Dublin, OH–based Cardinal Health Inc. has announced that it has completed its acquisition of privately-held AccessClosure Inc. (Santa Clara, ...
Tags: Accessclosure Takeover, Cardinal
An FDA news release has announced that the agency has given de novo approval to the Deka Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram ...
Tags: Bionic Arm, medical device
Ryan Heniford, Business Development Director at Secant Medical,Ryan Heniford. His presentation will highlight Secant Medical's research and development in biomaterials and advanced textile structures for regenerative medicine applications. ...
Blood glucose test strips sold in these packages have been declared misbranded by FDA and should not be used. (Courtesy FDA) FDA has announced the recommendation that use of Shasta Technologies' GenStrip Glucose Test Strips be ...
Tags: FDA, Certification, Health, Medicine
The FDA is providing the Medical Device Innovation Consortium (MDIC) with nearly $500,000 to conduct research to better understand patient preferences, and how to integrate such preferences into the development of medical devices, the group ...
Zimmer Holdings announced Thursday that it will acquire Biomet in a $13.5 billion transaction that will provide it with a leading position in the $45 billion musculoskeletal industry. The merger between the two Warsaw, IN–based ...
Intuitive Surgical stock fell 11.5% in value on Wednesday after a disappointing quarterly earnings report and the FDA raising cancer concerns over how robotic hysterectomies are performed. The Sunnyvale, CA–based maker of da Vinci ...
In a development that sounds as if it was lifted from the storyline of a vampire melodrama, a British research consortium has announced that it is well on its way to producing human blood on a scale that makes transfusions into real people ...
The FDA appears to be issuing another Class I designation involving Abbott Laboratories' voluntary recall of diabetes products. Back in January, the FDA said FreeStyle and FreeStyle Lite test strips could cause serious injury or death ...