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The FDA has issued a Form 483 to Elite Biomedical Solutions citing problems with its complaint records, process and nonconforming product documentation, and validation procedures. Read More
The EU’s Medical Device Coordination Group (MDCG) clarifies in a new guidance that seemingly minor changes can make it necessary for a device manufacturer to assign a new UDI-DI to a product. Read More
The company also reported that another of its rapid COVID-19 antigen assays, the LumiraDx SARS-CoV-2 Ag Test, has received an Emergency Use Listing from the World Health Organization. Read More
Devicemakers are asking for more time to implement the FDA proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More
San Diego, Calif.-based Illumina has secured a CE mark in Europe for its TruSight Oncology (TSO) comprehensive assay that can now be used as a companion diagnostic to identify cancer patients with a rare gene mutation for treatment with Bayer’s Vitrakvi (larotrectinib). Read More
Boston Scientific’s Acurate neo2 transcatheter heart valve showed a “significantly lower” frequency of cardiac complications than earlier versions of the device, Italian researchers reported in the journal of the American College of Cardiology. Read More
Vibrant Gastro is touting positive results from a late-stage study of its drug-free treatment for adults with chronic idiopathic constipation (CIC). Read More
The incubator will be used first by the UK’s National Health Service in a pilot program to help maintain the core temperature of babies being moved around hospital sites. Read More