The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Telemedicine Association, Heraeus, Zimmer Biomet.
Glympse Bio has closed an oversubscribed $46.7 million series B financing, with an eye toward boosting its novel biosensor platform in fibrotic diseases, including nonalcoholic steatohepatitis (NASH), oncology and infectious diseases.
Novasight Ltd. has scooped up $8 million in a series A financing that’s intended to get the company through a pivotal study of its first U.S. indication, Curesight, as well as to advance other pipeline products. The Israeli startup is tackling a range of pediatric vision disorders using artificial intelligence and eye-tracking technology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.AI, Corneat Vision, Dante Labs, GI Supply, Hd Medical, Qubyx, Revamp Medical, Vela Diagnostics, Vitls, Viveve.
If there’s a readily visible upside to the COVID-19 pandemic, it may be that telehealth is not only much more accessible, it’s also supremely topical among policymakers. However, privacy concerns are still a significant source of drag in some respects, a consideration that extends to digital medicine as well in the context of contact tracing used to corral the SARS-CoV-2 virus.
TORONTO – Edmonton’s University of Alberta is lending its neuromotor research smarts to a wearable, machine learning driven sensors platform developed by Menlo Park, Calif., and Calgary, Alberta-based Protxx Inc. for better managing the future care of patients suffering from neurodegenerative conditions such as multiple sclerosis (MS).
Infervision Technology Co. Ltd. has received the green light from the U.S. FDA for its Inferread Lung CT.AI product. The artificial intelligence- and deep learning-based technology automatically performs lung segmentation and identifies and labels different types of lung nodules. According to the 510(k) notification, Inferread Lung CT.AI “is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infervision.
Biointellisense Inc. received an FDA clearance in January for its Biosticker to monitor patient vital signs at home for as long as 30 days. It was just starting to launch, when along came the novel coronavirus. Now, the Band-Aid-sized monitor is being used to monitor COVID-19 patients at home, as well as chronic disease patients.
HONG KONG – Hong Kong’s emerging med-tech sector is getting a boost from a government-funded program aimed at sharing technology with other jurisdictions, a program driven in part by the need to contain the COVID-19 pandemic and continue opening regional economies.
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