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HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first histotripsy platform available in the U.S. Read More
Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing authorization by the FDA. Read More
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