Butterfly Network Receives 510(K) Clearance for Chip-Based Imaging System October 31, 2017 The company develops artificial intelligence applications. Read More
FDA Designates Zealand Product as Orphan Drug October 31, 2017 Short-bowel syndrome can result in complete loss of intestinal function. Read More
DHS Warns of Cybersecurity Risks in Boston Scientific Cardiac Systems October 30, 2017 The products are used worldwide to communicate with implanted pacemakers and defibrillators. Read More
FDA Publishes Guidance for Developing Gastroesophageal Reflux Treatments in Children October 30, 2017 Sponsors should at least address the entire pediatric age range. Read More
Magellan Diagnostics Distributed Unapproved Testing Systems, FDA Says October 27, 2017 Magellan, a subsidiary of Meridian Bioscience, received a Form 483 after an FDA inspection revealed significant violations. Read More
Alzheimer’s Drug Put on Fast Track October 27, 2017 The target population could be expanded in further investigations of the treatment. Read More
Renishaw Wins FDA Approval for Neurosurgery Planning Software October 26, 2017 Neurosurgeons can use the software to create plans based on procedure type. Read More
FDA Approves Shingrix for Shingles October 26, 2017 Shingrix is a non-live, recombinant subunit vaccine for shingles and its complications, such as postherpetic neuralgia. Read More
Abbott Wins Marketing Clearance for First Smartphone-Compatible Cardiac Monitor October 25, 2017 The data collected are transmitted to a physician via a mobile app. Read More
FDA Approves New Diabetes Drug Formulation for AstraZenaca October 25, 2017 Bydureon is indicated for adults with type-2 diabetes. Read More
CDRH Extends Experiential Learning Program for 2018 October 24, 2017 The program gives the FDA staff a better understanding of the products they review. Read More
Celgene Drops Crohn’s Disease Drug October 24, 2017 Celgene said it will continue development of other drugs for Crohn’s. Read More