Japan Clears Foundation Medicine’s Genomic Profiling Assay January 3, 2019 The assay can identify gene rearrangements that have been found to spur cancer growth. Read More
Edwards Lifesciences’ Heart Valve Approved January 3, 2019 The enhanced valve includes a new delivery system. Read More
FDA Approves Teva’s Digital Inhaler January 3, 2019 The inhaler is indicated to treat or prevent bronchospasms in patients aged four years or older. Read More
Chinese Devicemaker Hit for Complaint Handling January 2, 2019 The firm’s complaint records failed to include evaluations of each complaint to determine their adverse event reportability. Read More
Japan Approves Coronary Orbital Atherectomy Device January 2, 2019 The device reduces calcium in a patient’s arteries and enables successful stent delivery. Read More
CDRH Posts List of Proposed Guidances for Fiscal 2019 January 2, 2019 Draft guidance topics include labeling for surgical staplers, cybersecurity and medical device servicing. Read More
FDA Will Continue Overseeing Discontinued Birth Control Device January 2, 2019 The agency will require blood tests of patients participating in follow-up visits during the post-market study. Read More
MHRA Calls for Labeling Updates for Emollient Creams December 28, 2018 The agency warned users to avoid smoking and approaching open flames when using emollients due to the risk of severe burns. Read More
Canada Issues Medical Device Action Plan to Improve Device Safety December 28, 2018 Health Canada expects to launch the main elements of its action plan in early 2019. Read More
InnovHeart Picks Medical Device Veteran as New CEO December 28, 2018 Bottiglieri previously served at Invatec, which was acquired by Medtronic and turned into its peripheral vascular business unit. Read More
Miris’ Human Milk Analyzer Cleared to Market by FDA December 28, 2018 The analyzer is intended to help parents and healthcare providers meet the nutritional needs of infants. Read More
AMRA Receives FDA OK for Magnetic Resonance Diagnostic Software December 27, 2018 The profiler enables an accurate assessment of a patient’s metabolic status. Read More