Dexcom Inc. ends 2022 on a high note with broad clearance from the U.S. FDA for its G7 continuous glucose monitoring system (CGM). The long-awaited 510(k) clearance encompasses use in people with all types of diabetes age two and older, positioning Dexcom to take advantage of expanded coverage of CGMs to include individuals on basal insulin-only for Medicare beneficiaries as proposed by CMS in October. Read More
The conviction and sentencing of Elizabeth Holmes and Sunny Balwani of Theranos Corp. might be seen as an example of retribution for testing technology that didn’t exist and thus endangered patients, but that perception doesn’t stand up to scrutiny. Read More
Minze Health NV closed on $4.1 million of seed funding to develop its digital solution for the treatment of urinary tract problems. Three major Belgian funds participated in this seed round, led by White Fund SA, a private equity fund focusing on med-tech. Capricorn Partners NV joined White Fund via its Digital Growth fund, alongside Flemish investment company PMV NV. Read More
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests. Read More
When a drug prevents bacteria from synthesizing their own folate, an essential compound for their survival, they take it directly from the host. This antibiotic resistance mechanism had not been detected until now because bacteria behave differently in the laboratory than they do in vivo during an infection. Read More
New hires and promotions in the med-tech industry, including: Altoida, Edwards Lifesciences, Eyenovia, Neogenomics, Novacyt, Pison Technology, Podimetrics, Verasonics, Verge Genomics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Alto Neuroscience, Onward Medical, Sight Sciences, Vida Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acoustiic, Aetion, Acuity Surgical, Endoclot, Integra, Mainz Biomed, Olympus, Surgical Innovation. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endomag. Read More
