The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Telehealth bill resurfaces in 117th Congress; OIG includes telehealth in FY 2021 workplan.
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S.
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S. Ourcrowd, an investment platform that simplifies investment by accredited investors and others in startups, early-stage companies and venture funds, led the round. Other participants included a group of family offices and private investors.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.
Royal Philips NV will close on its $635 million acquisition of Capsule Technologies Inc. in the first quarter of 2021, continuing the expansion of the Dutch company's remote monitoring capabilities. Capsule's Medical Device Information Platform integrates nearly all medical devices used in hospitals with electronic health records in a vendor-neutral system. The deal has already received approval from the U.S. Federal Trade Commission and the Department of Justice.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardiovascular Systems, Cytosorbents, Depuy Synthes, Impulse Dynamics, Medibio, Occlutech, Q Core Medical, Seno Medical, Theralight, Transenterix.
Abbott Laboratories plans to launch its Neurosphere Mypath digital health app in the coming weeks, the latest addition to its Neurosphere Digital Care connected health management platform. The new app will enable chronic pain patients trying out Abbott neuromodulation therapies to track and report their pain relief.
The volume of med-tech deals and M&As in 2020 reached impressive levels, well above 2019, primarily due to the demands of a global pandemic, although the disclosed values of those alliances fell dramatically short. Even so, the spotlight that shined on digital health and diagnostics throughout the challenging year has potentially set up the med-tech industry for an influx of attention going forward.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum.
What is the outlook for investment in digital health over the coming year? A group of investment experts tackled that question during a session of the Digital Medicine & Medtech Showcase, which is being held virtually this week. Although COVID-19 was disruptive, there was a huge increase in health innovation investment last year, with a jump of roughly 56%, said Logan Plaster, director and editor-in-chief at Startup Health.
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