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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
Medical Device Single Audit Program (MDSAP) regulatory authorities (RAs) have extended the program’s remote audit arrangements until Sept. 30. 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
Canadian diagnostics company Nanostics released interim trial data showing its ClarityDX prostate test is 147 percent more specific than the prostate-specific antigen (PSA) blood test for predicting clinically significant prostate cancer. 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 has granted 510(k) marketing clearance to Invictus Sterilization’s Aura Storm hospital-grade ultraviolet medical air purifier. The North Carolina-based company makes surface and air sterilization products that use ultraviolet C light. 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approaches to developing and modifying clinical outcome assessments (COA) for clinical trials of medical devices, in a draft guidance released yesterday.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