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Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
Patients with herniated discs enjoyed considerable pain relief after surgery using Hoogland Spine Products’ MaxMoreSpine endoscopic system, the company reported, citing a study by researchers in the Netherlands and the New York-Presbyterian Weill Cornell Brain and Spine Institute in New York. Read More
High-risk “class D” in vitro diagnostics (IVDs) should get specialized handling from their manufacturers and the third-party notified bodies authorized to approve them on behalf of the EU, said the Medical Device Coordination Group (MDCG), which is made up of experts appointed by EU member states. Read More
The best way for Congress to help the FDA address its concerns about reports of a high level of false-positive results from noninvasive prenatal testing (NIPT) is to pass new legislation, the FDA said in a Feb. 11 letter to lawmakers. Read More
San Francisco, Calif.-based Sirona Medical has acquired two FDA-cleared products from Nines, another California radiology software developer, expanding its portfolio of products that use artificial intelligence (AI) for analysis of radiographic images. Read More
The FDA has released its long-awaited proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More
UK-based Parasym’s neuromodulation device significantly improved cardiac mechanics and inflammation in heart failure patients in a clinical trial at the University of Oklahoma. Read More
Devices and replacement parts that are “printed” using new three-dimensional printing technologies must meet the same quality benchmarks as traditionally manufactured devices, trade groups emphasized in written comments to the FDA. Read More
It's problematic that the FDA’s recently released device software draft guidance lacked input from the Center for Drug Evaluation and Research (CDER), two industry groups said in written comments to the agency. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has recommended several diagnostic devices for use in biopsies for suspected prostate cancer. Read More
The FDA doesn’t want any part of regulating the “sanitation tunnels” that have popped up in certain commercial settings as a response to the COVID-19 pandemic. Read More