RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump.
Elucid Bioimaging Inc. has already gained an FDA clearance and a CE mark for its Vascucap artificial intelligence-based software that analyzes CT angiograms (CTA) to characterize and quantify atherosclerotic plaque to predict a patient’s stroke risk. But recent interim data presented on July 2, 2020, at the Society for Vascular Surgery conference found that the AI algorithm is more effective than standard-of-care diagnostics.
Conventional wisdom has it that recent expansions in coverage of telehealth will never be fully reversed. The addition of artificial intelligence (AI) into telehealth could solve several issues faced by doctors and hospitals. There is some concern, however, that the blending of AI and telehealth will industrialize the practice of medicine, dissuading patients from seeking critically needed care.
Hong Kong – Vuno Inc. is looking to access more markets after inking a partnership with Japan’s M3 on June 19. The partnership with M3, a medical data platform which is 34% owned by conglomerate Sony Corp., allows Vuno to tap into the Japanese market. The M3-Vuno tie-up aims to encompass all Vuno’s existing products.
Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics.
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
HONG KONG – Israeli companies have produced some promising med-tech solutions for COVID-19, and the artificial intelligence space is turning out to be a particularly strong area of expertise for that tiny but mighty nation. One of the four health maintenance organizations (HMO) in Israel, Maccabi Healthcare Services, has deployed a new AI-powered algorithm that identifies individuals estimated to be at the highest risk of severe COVID-19 complications due to pre-existing conditions and other health factors.