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Quebec, Canada-based OxyNov has filed a 510(k) submission to the FDA for its FreeO2 device that automatically adjusts a patient's oxygen flow. Read More
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
Six EU countries have turned up the heat on medical product sponsors who haven’t shared the findings of their clinical trials, with significant success, a new analysis finds. 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In comments on the third installment of the FDA’s draft guidance on patient-focused drug development, AdvaMed has recommended that the guidance not apply to medical devices — although the industry association says it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