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Cell Bio-Systems’ disposable surgical instrument has passed four final tests for biocompatibility, the medical-device developer announced. The completion of the tests clears another hurdle in gaining FDA approval.
It looks like a video game, but a new virtual system is essentially a brain game plan for surgeons to map out brain surgery before a blade even penetrates the skull.
Two independent studies concluded that Given Imaging’s PillCam ESO is an accurate, noninvasive alternative to upper endoscopy, the current “gold standard” for evaluating patients, and the most commonly performed procedure in detecting esophageal varices in cirrhotic patients, according to the January issue of Endoscopy.
Skilled vendors can do a lot for an FDA-regulated life sciences firm -- but if there are problems with their work, the agency will place the burden of responsibility on you and make it tough to shake, an industry expert said.
Legislative uncertainty and costs are slowing adoption of anticounterfeit technology, a new study contends, with only about 10 prescription drug products expected to contain radio frequency identification (RFID) tags on a large scale.
Texas-based LDR Spine received an investigational device exemption (IDE) from the FDA to conduct clinical trials with their Mobi-C artificial cervical disc, the company announced Feb. 1.
Medical device manufacturers, physicians' offices and others involved in the edata chain of patient information are struggling to adopt electronic health records (EHRs) because of cost barriers and a lack of standards, experts told PIR last week.