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The California company received complaints about patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device. Read More
The agency has authority to exempt class II devices from requiring 510(k) submissions if it can determine that a 510(k) clearance is not necessary to assure their safety and effectiveness. Read More
Current resources in Europe are too limited to ensure the new regulatory regime will be successfully implemented within the desired timeframes, according to MedTech. Read More
Maquet Cardiovascular filed a patent infringement lawsuit with the U.S. District Court for Massachusetts against Abiomed over the company’s intravascular blood pumps. Read More
The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Read More
China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to… Read More
The guidance covers the use of recognized standards, drug-device combination products, investigator-sponsored investigational testing, and stages of product development. Read More
The new guidance provides details on the clinical trial data needed to assess safety and efficacy of medical devices and in vitro diagnostics intended for registration in China. Read More