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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
The test detects antibodies of treponemal (TP) bacteria associated with syphilis as well as nontreponemal (nTP) antibodies that indicate active or recent infection. Read More
A proposed regulation issued by the FDA today would amend current Good Manufacturing Practice (cGMP) rules for combination products containing medical gases, focusing on requirements for standardized labeling and manufacturing procedures specifically for drug-device combinations. Read More
In a recently promised update on medical device reports (MDR) associated with suspected foam breakdown in certain Philips Respironics devices, the FDA reports it received more than 21,000 MDRs, including 124 reports of deaths, from April 2021 through April 2022. Some of the injuries noted by the FDA include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules and chest pain. Read More