Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Biosystems, Cardinal Health, Qiagen, Roche.
Neuronetics Inc., of Malvern, Pa., has won U.S. FDA breakthrough device designation for its Neurostar transcranial magnetic stimulation (TMS) device for the treatment of patients with drug-resistant bipolar depression. The news comes as the company reported a strong fourth quarter for 2019, with revenue up 11% year-over-year to $17.4 million.
LONDON – Ibex Medical Analytics is preparing for commercial rollout in Europe after receiving CE-IVD marking for its artificial intelligence (AI) decision support system for automated interpretation of prostate cancer biopsies. Galen Prostate, trained on more than 60,000 samples from multiple institutions, is intended to give a second opinion on digitized slides, following initial assessment by a pathologist.
PERTH, Australia – After more than three years of consultations, Australia’s Therapeutic Goods Administration (TGA) finally has unveiled a new regulatory framework for custom-made and 3D-printed devices that aligns with international standards.
Aerin Medical Inc., an Austin, Texas-based company focused on minimally invasive solutions for chronic nasal conditions, has won U.S. FDA clearance for the Rhinaer Stylus to treat chronic rhinitis. The Rhinaer procedure can be performed under a local anesthetic in an ear, nose and throat (ENT) physician’s office, with no incisions and minimal discomfort.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Clinical Laboratory Association, DNA Technologies, Texas Instruments, Dialog Semiconductors, Telink Semiconductors.
With an eye toward helping those with early stage hepatocellular carcinoma (HCC), Basel, Switzerland-based Roche Group has won a breakthrough device designation from the U.S. FDA for the Elecsys GALAD score. When combined with ultrasound, the Elecsys GALAD score aims to help provide more accurate information for clinicians to treat patients at an earlier stage.
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