Myriad Genetics announced that it has launched the EndoPredict® test in the United States for patients with ER+ HER2- early-stage breast cancer. EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.
“Today’s … Continue reading
ViewRay, Inc. announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company’s next generation linear accelerator-based MRI-guided radiation therapy system.
“FDA clearance of the MRIdian Linac is a transformative milestone for ViewRay,” said Chris A. … Continue reading
Scopis, a company specializing in surgical navigation and medical augmented reality, announced today that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) and Health Canada Medical Device License (MDL) for its breakthrough next-generation surgical navigation products for ear, nose and throat (ENT) surgery. … Continue reading
Patients could one day self-administer vaccines using a needleless, pill-sized technology that jet-releases a stream of vaccine inside the mouth, according to a proof-of-concept study conducted at UC Berkeley.
The study did not test vaccine delivery in people, but demonstrated that the technology, called MucoJet, is capable of delivering vaccine-sized … Continue reading
Boston Scientific announced the German District Court of Düsseldorf has determined that Edwards Lifesciences Corporation and its German subsidiary’s Sapien 3™ device infringed two patents of Boston Scientific Scimed, Inc. related to the seals for transcatheter heart valves, specifically the German parts of EP 2 749 254 B1 and EP … Continue reading
FDA issued warning letter to Denttio Inc, in which FDA cited 12 violations to regulations. These regulations include but not limited to
1. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). 2. Failure to establish … Continue reading