The authors of a recent journal article see problems with the FDA’s approach to premarket review of artificial intelligence (AI) algorithms, including an undue reliance on single-site algorithm development. Regulatory attorney Brad Thompson told BioWorld, however, that hospital administrators want algorithms that maximize accuracy for their populations and are not averse to in-house development of just such an algorithm, thus creating a source of tension between what hospitals want and what the FDA expects. Read More
COVID-19 has caused a surge in telemedicine, increasing access to health care without having to physically visit a doctor. In similar ways, it is changing things in the operating room, where advanced technology platforms enable surgeons and specialists to observe or weigh in on surgeries and allow manufacturer reps to assist in procedures using new devices. Read More
NASA is ready to begin testing the E-Nose COVID-19 screening device prototype developed by subcontractor Variable Inc., of Chattanooga, Tenn. NASA received $3.8 million from the Department of Health and Human Services to enhance E-Nose, which was originally developed to measure air quality inside spacecraft. The updated version is intended to facilitate screening for SARS-CoV-2 by "sniffing out" the signature volatile organic compounds (VOCs) in the breath of infected individuals. Read More
HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions. Read More
While strong financial markets could create merger and acquisition headwinds for med tech, the volume of both M&As and deals are rising above each of the prior three years, indicating a growing industry interest that is not always clear in the financials. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig Technologies, Control Bionics, Genetic Technologies, Infinity Biologix, Lucira Health, Numotion, Outset Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Activ Surgical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage. Read More
Keeping you up to date on recent developments in neurology, including: Blood test for depression, bipolar disorder developed; Specialized hydrogel helps repair circuitry in severe TBI; Using AI to diagnose neurological diseases based on motor impairment. Read More
