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San Mateo, Calif.-based Cala Health’s Trio device reduced essential tremor (ET) an average of 71 percent in patients in a two-year real-world evidence study, according to results published in the peer-reviewed journal Tremor and Other Hyperkinetic Movements. Read More
Med Pen Concepts’ Plasma MD and Plasma +, products intended to improve the appearance of skin by stimulating the production of collagen, are not approved by the FDA and are not manufactured using current good manufacturing practice requirements, the agency said in a warning letter to the company. Read More
The FDA will focus its regulatory authority on a subset of software functions that are medical devices and could pose a risk to patient safety if they do not act as intended, the agency said in a final guidance published Wednesday. Read More
The FDA said it won’t enforce former Federal Food, Drug and Cosmetic Act (FD&C) requirements for certain medical device data systems (MDDS), medical image storage devices or medical image communication devices, in a final guidance released yesterday. Read More
In comments on the third installment of the FDA’s draft guidance on patient-focused drug development, AdvaMed has recommended that the guidance not apply to medical devices — although the industry association says it supports the overall use of patient experience measures as clinical trial endpoints. Read More
The version of FDA user fee legislation that’s slated to get attached to a continuing resolution (CR) later this week — just days before the end of the agency’s fiscal year — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Read More
The FDA clarifies its regulatory approach to clinical decision support (CDS) software and gives examples of what it considers non-device CDS software in a final guidance published yesterday. Read More
The FDA is now prioritizing its review of Emergency Use Authorization (EUA) requests on a smaller subset of experienced developers applying for tests that are likely to have either a significant public health benefit or fulfill an unmet need, according to final guidance released by the agency Tuesday. Read More
Artivion’s study of its On-X mechanical aortic valve with the anti-clotting drug apixaban rather than warfarin was halted early for futility. Read More
Observations from the FDA’s Software Precertification Pilot Program confirmed that the rapidly evolving device software category needs a new “regulatory paradigm,” the agency said in a report on the now-completed pilot. Read More