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The FDA’s annual announcement of planned enhancements to its electronic medical device report (eMDR) portal advises devicemakers that use the agency’s Electronic Submissions Gateway (ESG) to update their submission systems accordingly. Read More
C&A Tool’s Auburn, Ind. device manufacturing facility received a Form 483 from the FDA for good manufacturing practice issues and other deficiencies observed during a Feb. 28 to March 3 inspection. Read More
French in vitro diagnostics company bioMérieux is contributing its expertise to a joint venture to develop both diagnostics and antimicrobials to fight pathogens that have evolved into antimicrobial resistance (AMR). Read More
Seno Medical Instruments received a Form 483 after the FDA inspected its San Antonio, Texas, facility last February and March, listing inadequate design control procedures and other lapses. Read More
Remidio, an India-based medical device company that develops eye testing technology using AI and telemedicine integrated devices, announced clinical trial results showing that its Medios Al algorithm can help detect patients with “referable” glaucoma. Read More
A Failure Modes Effects and Criticality Analysis (FMECA) begins with planning — and the FMECA plan should define the objectives and scope of the analysis and identify the desired outcome. Read More
The European Commission has issued a regulation for manufacturers of high-risk, Class D in vitro diagnostics, giving them two years to comply with the EU’s In Vitro Diagnostic Regulation (IVDR). Read More
NeuroEM Therapeutics announced that its MemorEM medical device has shown the ability to “re-balance” the immune system in Alzheimer’s Disease patients enrolled in a clinical trial. Read More