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The FDA said the Banyan Brain Trauma Indicator has the potential “to rule out the need for a CT scan in at least one-third patients who are suspected of having mTBI.” Read More
The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead test results associated with Magellan’s LeadCare test systems. Read More
Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Read More
The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction. Read More
The FDA issued “immediately in effect” guidance for manufacturers of Class I and unclassified medical devices on compliance dates for meeting unique device identification requirements. Read More