Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Cartiheal, Life Spine, Nanovibronix, Optellum, Shockwave Medical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Masimo, O'Brien, Synchron, University of Portsmouth.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig, Caire, Caredx, Curi Bio, Elekta, Hologenix, Keen Eye, Medanex, Medline, Namsa, Quanterix, Stembiosys, Ultivue.
New hires and promotions in the med-tech industry, including: Advanced Ostomy Tools, Contraline, Delfi Diagnostics, Innovheart, M2gen, Tissuevision, Voxneuro.
While the Medicare Coverage of Innovative Technologies (MCIT) program has been formally abandoned, the U.S. CMS has resurrected those policy underpinnings in the form of the Transitional Coverage for Emerging Technologies (TCET) concept. Several speakers on a recent webinar said the TCET paradigm should allow CMS to promptly rescind coverage in the event of a safety signal, including Mark McClellan, who has served as both FDA commissioner and CMS administrator.
The ongoing tension between manufacturers of imaging systems and entities that perform extensive servicing activities has prompted activity on Capitol Hill in the form of H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act.
Nalagenetics Pte. Ltd. has landed $12.6 million in a series A round of financing. The Singapore-based company wants to use the capital to expand on its genetic testing solutions to implement predictive and presymptomatic testing for prevention geared towards chronic conditions in Asia.
After more than 10 years on the market in Europe, Staar Surgical Co. can finally see a brighter future for its newest lenses in the U.S. This week, the company received FDA premarket supplement approval of its Evo/Evo+ Visian implantable lens for the correction of myopia and myopia with astigmatism in patients aged 21 to 45. Made of a proprietary poly(2-hydroxyethyl methacrylate)-based collagen co-polymer the company calls Collamer, the lens is inserted behind the iris in a quick procedure and can be removed, if needed. Unlike laser-assisted in situ keratomileusis (LASIK), the Evo procedure does not remove corneal tissue.
Biobeat Technologies Ltd. reported its remote patient monitoring system received FDA clearance to monitor respiratory rate and body temperature. The wireless chest and wrist monitoring device is already cleared for cuffless blood pressure monitoring, blood oxygen saturation and pulse rate. The artificial intelligence platform utilizes a photoplethysmography-based sensor at the surface of the skin that measures volumetric variations of blood circulation.
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