A new tool for mobile devices can diagnose stroke as accurately as an emergency medicine specialist in just minutes, enabling patients to get brain-saving therapies in time for maximum benefit. According to researchers from Pennsylvania State University and Houston Methodist Hospital, the artificial intelligence (AI)-based tool could counterbalance physician biases, reducing both overuse of CT scans and underdiagnosis of mild and moderate stroke. Read More
Drug and medical device manufacturers have several compliance matters to deal with under the False Claims Act (FCA), only one of which is the Anti-Kickback Statute (AKS). Nonetheless, the AKS might be a good area for members of industry to emphasize, given that it accounted for the vast majority of federal enforcement actions in fiscal year (FY) 2019, according to a new report by Gibson, Dunn & Crutcher LLP. Read More
Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours. Read More
Researchers at Ontario’s University of Waterloo have developed a palm-sized device that uses radio waves to read blood glucose levels, as well as artificial intelligence (AI) software to get near instantaneous results. Read More
The Chinatrials roundtable went virtual this year and drew clinical trial experts to discuss state-of-the-art clinical trial design strategies, which are increasingly important in a more competitive clinical landscape. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nuclear Regulatory Commission issues advisory letter to INIS; HHS authorizes pharmacy interns to test for COVID-19. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1health.io, Arc Bio, Genesprint Group, Holo Surgical, IMEC, Infrawear, Remote Medical International, Royal Philips, Suralign Holdings, TÜV Rheinland. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GI Supply. Read More
Keeping you up to date on recent developments in neurology, including: MIT develops wearable sensor for ALS patients; Cord blood DNA can hold clues for early ASD diagnosis and intervention; ENIGMA consortium offers hope for improving treatment of brain injuries. Read More