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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with laparoscopic power morcellators (LPMs) — including testing for permeability, burst strength and leakage — in a new draft guidance.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
Cyberattacks have become a routine occurrence, prompting radical changes in the way device manufacturers think about the problem, all the way back to the design stage, according to a panel discussion Tuesday at the Food and Drug Law Institute’s annual conference. Read More
The Verifying Accurate Leading-edge IVCT Development (VALID) Act was included as part of user fee reauthorization legislation that passed through the Senate Committee on Health, Education, Labor and Pensions (HELP) Tuesday in a 13 to 9 vote. Read More
The EU’s Medical Device Coordination Group (MDCG) is warning device companies that they risk not being able to market their previously approved products in Europe if they are not in compliance by the time the transitional period for the Medical Device Regulation (MDR) ends on May 26, 2024. Read More
A user of SoClean’s device for cleaning continuous positive airway pressure (CPAP) devices is seeking a federal class action lawsuit against the company, claiming that the cleaning machine leaks toxic ozone gas. Read More
The FDA’s Special 510(k) application review can offer devicemakers the path of least resistance to market clearance, an official from the FDA’s Center for Devices and Radiological Health (CDRH) said, as long as the device meets specific criteria. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic drug-device combination products if the generic product’s user interface is substantially different from the original product. Read More