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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

March 29, 2022

View Archived Issues
Evo Visian ICL illustration over eye

Future comes into focus for Staar Surgical with FDA approval

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. Read More
Biobeat smartwatch and patch

Biobeat adds new FDA clearances to remote monitoring device

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. Read More
CMS-medicare-reimbursement.png

Withdrawal of Medicare coverage a crucial feature for successor to MCIT program

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. Read More
DNA-dollars.png

Nalagenetics raises $12.6M for preventative care gene testing

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. Read More
U.K. flag and capsules

Clinicians outline UK plan for integrating pharmacogenomics into prescribing

Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug. Read More

New legislation tackles debate over remanufacturing of medical technology

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. Read More
Microscope

Experts: Using march-in ‘blowtorch’ on drug prices threatens US research enterprise

Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities. Read More

Appointments and advancements for March 29, 2022

New hires and promotions in the med-tech industry, including: Augmedix, Enzo Biochem, Sense Biodetection, Paragon 28. Read More

Financings for March 29, 2022

Med-tech firms raising money in public or private financings, including: Qure.ai, Vascular Therapies. Read More

In the clinic for March 29, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Carthera, Focalyx Technologies, Lucira Health. Read More

Other news to note for March 29, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 8chili, Apria, Aventyn, Bausch Health, Caredx, Carmat, Fusion Orthopedics, Glassbeam, Maximbio, Owens & Minor, Phantom Healthcare, Pixium, Recor Medical, Treace, Valeant. Read More

Regulatory actions for March 29, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cellmyx, Envista. Read More

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