Thermo Fisher Scientific’s clinical sequencing business and AstraZeneca announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca’s expanding portfolio of targeted therapies.
A federal appeals court on Aug. 16 revived nearly 6,000 lawsuits alleging that a widely used device produced by 3M Co. to keep surgical patients warm caused them to develop infections.
The U.S. Food and Drug Administration approved Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke.
Scientists from the University of California, San Francisco have developed a tool that would give paralyzed persons who are unable to speak the ability to communicate through text that appears on a screen.
St. Jude Medical, which was acquired by Abbott Laboratories in 2017, agreed to pay $27 million to settle allegations the company knowingly sold defective heart devices, the U.S. Justice Department said on July 8.
Abbott’s Xience family of stents received U.S. Food and Drug Administration approval for one-month (as short as 28 days) dual anti-platelet therapy labeling for high bleeding risk patients in the United States.
GALIEN DIGITAL HEALTH WEBINAR SERIES The Incubators of Innovation: Academic Medical Centers As Digital Health Champions THURSDAY, JUNE 24, 2021 1:00 PM – 2:00 PM ET Register Academic medical center incubators are launching pads for digital health, medical device and health information startups as they develop and prepare their ideas and innovations for market entry. […]
Clinical Ink’s white paper discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations, and a Phase III case study.
The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
AbbVie Inc.’s Allergan Aesthetics announced the acquisition of Soliton Inc. in a definitive agreement that is valued at $550 million. Allergan Aesthetics will pay $22.60 per share for each outstanding Soliton share.