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The FDA issued Advanced Facialdontics a Form 483 for lacking a complete design history file and other deficiencies observed during an inspection of the company’s East Islip, N.Y., facility in July. Read More
The FDA has granted Emergency Use Authorization (EUA) to Winnipeg, Canada-based PADM Medical’s biodegradable, plant-based face mask for use in healthcare and medical settings. Read More
Federal juries in Texas and Arkansas have found in favor of Johnson & Johnson’s Ethicon subsidiary in two lawsuits over the company’s pelvic mesh product used to treat stress urinary incontinence in women, finding that the device had no design defect. Read More
The FDA has pushed back once again on Supernus Pharmaceuticals’ New Drug Application (NDA) for its investigational apomorphine infusion device, designed to continuously treat motor fluctuations in Parkinson’s disease (PD). Read More
The Centers for Medicare and Medicaid Services (CMS) will draft a proposed rule that would create an expedited Medicare coverage pathway for medical devices, according to a CMS op-ed piece published in JAMA Internal Medicine. Read More
Quality management in the supply chain relies on traceability of and accountability for device components and finished products anywhere in the world, according to one supply chain management authority. Read More
DNA sequencing giant Illumina is teaming up with AstraZeneca to seek out potential new drug targets using Illumina’s genomic analysis artificial intelligence (AI) technology. Read More
Microbot Medical has purchased Nitiloop’s FDA-cleared microcatheters, used in minimally invasive endovascular surgery to thread guidewires to damaged blood vessels, beyond stenotic lesions, and remove blood clots. Read More
OrthoGroup was handed a Form 483 after an inspection of its Rancho Cordova, Calif., facility found incomplete device history records (DHR), missing corrective and preventive action (CAPA) records and multiple procedures not being followed. Read More