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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approaches to developing and modifying clinical outcome assessments (COA) for clinical trials of medical devices, in a draft guidance released yesterday.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
The FDA offers recommendations on nonclinical assessments of containment systems used with laparoscopic power morcellators (LPMs) — including testing for permeability, burst strength and leakage — in a new draft guidance. Read More
GI Dynamics’ announced final data from a multisite clinical study of its experimental EndoBarrier system, saying it met its endpoints in glycemic control efficacy and serious adverse events (SAE). Data also show clinically significant weight loss, the Boston-based company said. Read More
The FDA’s Center for Device and Radiological Health (CDRH) has released final guidance on what technical performance assessment and user information should be included in a premarket submission for radiological devices with quantitative imaging functions. Read More