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The FDA issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue and on the use of LPM containment systems. Read More
Failure to establish procedures to control product that did not conform to specifications, as well as procedures to ensure equipment is routinely checked, were among the deficiencies uncovered during an FDA inspection of contract manufacturer Apical Instruments of Redwood City, California. Read More
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Read More
The FDA has released a new action plan that outlines a potential approach to premarket reviews for artificial intelligence (AI) and machine learning-(ML) software modifications. Read More
The FDA is introducing a new review program for medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
Toland’s first task will be to steer the commercialization of the company’s Symani Surgical System, a two-arm robotic microsurgery platform cleared in the EU in 2019. Read More
The software is now included in Swoop’s standard software package, taking just minutes after scanning to assess and annotate the brain images. Read More
Among other observations, the FDA investigator found a lack of evidence demonstrating if a sterile barrier is maintained in packaging when the product is stored under worst-case conditions. Read More
Corrective and preventive actions were also found to be inadequate because they didn’t ensure that the root cause of nonconformances was identified during investigation, the Form 483 said. Read More