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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
Virpax said it expects to complete stability testing, human factors testing for medical devices, safety studies and supplementary in-vitro studies. 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
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
Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) accused leading device manufacturers of trying to "undermine" the availability of over-the-counter hearing aids, in a newly published report. Read More
The FDA is proposing to reclassify two high-risk, class III devices — optical diagnostic devices for melanoma detection and electrical impedance spectrometers — into class II (special controls) subject to 510(k) clearance. Read More
The Office of Management and Budget has belatedly posted its Spring regulatory agenda for the federal government, including the following medical device-related proposed and final rules that the FDA is aiming to release. Read More
Sunnyvale, Calif.-based Aerin Medical’s VivAer Stylus treatment for nasal airway obstruction due to nasal valve collapse showed positive four-year results in a postmarket study. Read More
Real-world evidence (RWE) can be especially difficult to gather for medical devices, the UK’s National Institute for Health and Care Excellence (NICE) points out in a new “framework” document on the topic. Read More
The FDA emphasizes the need for high-quality approaches to developing and modifying clinical outcome assessments (COA) for clinical trials of medical devices, in a draft guidance released yesterday. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it is planning new device regulations aimed at improving patient safety and encouraging innovation. Read More