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This European Edition of Quick Notes includes guidelines from WHO for pharmaceutical quality control laboratories, UK launch of the Innovative Devices Access Pathway pilot, European Commission (EC) unannounced antitrust inspections at a medical device company and an open letter to the EC about MDR and IVDR. Read More
Despite positive and sometimes emotional testimony from diabetes patients, an FDA advisory committee voted Thursday to uphold CDER’s recommendation that the new drug application for ITCA 650 (exenatide in DUROS device), Intarcia Therapeutics’s diabetes drug/device combo, be denied approval. Read More
In this edition of Quick Notes, we cover innovative medical devices including a mixed reality system for surgical navigation, robotic system for use in an MRI, a headband EEG and a point-of-care system to detect cardiac disease. Read More
Creating a new medical device classification, the FDA has granted Xenex Disinfection Services’ LightStrike+ high-intensity, broad-spectrum ultraviolet (UV) light robot a De Novo marketing authorization. Read More
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
Withings’ Body Scan health station received FDA clearance for its weight-scale style device that provides users a home electrocardiogram (ECG). Read More