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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
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approaches to developing and modifying clinical outcome assessments (COA) for clinical trials of medical devices, in a draft guidance released yesterday.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
Endologix said it is preparing to submit its Detour percutaneous bypass system for the FDA’s premarket approval, following the successful outcome of a pivotal study. Read More
Failure to treat all medical device complaints as complaints is among the leading pitfalls related to Medical Device Reporting (MDR), according to Pamela Forrest, a former FDA official who is now a partner in the law firm Covington & Burling. Read More
Insightec’s Exablate ultrasound cancer therapy is safe and effective against prostate cancer, according to the results of a multisite study reported in The Lancet Oncology. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) announced strategic priorities for 2022 to 2025 earlier this year that will mean some challenges as well as potential benefits for devicemakers, including increased attention to diversity in clinical trials, according to one prominent regulatory attorney. Read More
Many digital health startups have the online sizzle without the clinical evidence steak, suggests a new study that shows fewer than half of companies surveyed have ever reached the point of clinical trials or regulatory filings. Read More