The U.S. FDA's two-day advisory hearing on industrial ethylene oxide (EtO) sterilization of medical devices wrapped up with a discussion of how duodenoscopes can be made safer. The conclusion was largely that employee churn, training and work conditions were the biggest challenges – issues over which the FDA has nearly zero leverage. Read More
Penumbra Inc. reported final results from its IDE trial of the Indigo Aspiration system at the Vascular Interventional Advances (VIVA) annual meeting in Las Vegas. The Alameda, Calif.-based company said that the EXTRACT-PE trial met its primary endpoints in patients with acute pulmonary embolism (PE). Read More
Preclinical animal and cellular models are notoriously bad at predicting drug candidate toxicity in humans. Animal biology is often fundamentally different on this front than in humans, while cells in the lab can't be counted on routinely to replicate the bodily response. Read More
TORONTO – On average, radiology specialists diagnose fewer than 50% of cases of collapsed lung or pneumothorax using chest X-rays, said systems design engineer Hamid Tizhoosh. The Insignio system developed at Tizhoosh's Kitchener, Ontario-based Kimia Lab has gone further by identifying 75% of cases of collapsed lungs using artificial intelligence (AI) to search a database of 550,000 patients and compare 30,000 cases of pneumothorax there to X-rays of new patients with unknown conditions. Read More
PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently. Read More
For more than two decades, the BioWorld team has understood that there's a vital need to know to stay competitive, to bring your novel ideas forward through the long cycle of development, testing and commercialization. Now we've upgraded our presentation of news and analysis. On Nov. 19, we're migrating to a fantastic new platform. Read More
