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Boston, Mass.-based Global Protection has received de novo authorization from the FDA to expand the intended use claim of its ONE and myONE brand condoms to include anal sex, with the agency stressing its commitment to the needs of diverse populations. Read More
An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Read More
To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may be related to the device problem. Read More
The FDA has issued a Form 483 to Becton Dickinson (BD) Caribe based on an inspection last November of the devicemaker’s facility in Juncos, Puerto Rico. 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
Dyad Medical’s Libby IAAA automatically does sensitive in vivo (within the heart) assessments for preclinical and clinical evaluations to optimize the design of the drug-eluting stents used to treat coronary artery disease. Read More