HeartBeam has received FDA clearance for its synthesized 12-lead ECG software, making it the first cable-free device of its kind for at-home arrhythmia assessment. The clearance followed a successful appeal of a previous not substantially equivalent determination, the company said…
Supply Chain
The House on Dec. 2 unanimously passed the Made in America Manufacturing Finance Act, a bipartisan bill that would expand federal loan limits for small manufacturers and aims to bolster domestic supply chain resilience. The legislation would increase Small Business…
An FDA advisory panel declined to endorse the Ventura interatrial shunt system, a heart failure device developed by V-Wave, a Johnson & Johnson company, according to a Dec. 5 TCTMD report. Panel members cited a lack of demonstrated benefit and…
Carson City, Nev.-based Carson Tahoe Health has expanded its prime vendor agreement with Medline to include lab distribution. The agreement, signed in August, transitions distribution for a core lab in Carson City and a second location in Minden, Nev., to…
Medtronic received FDA clearance for its Hugo robotic-assisted surgery system for urologic procedures. The clearance allows the system to be used in minimally invasive surgeries, including prostatectomy, nephrectomy and cystectomy — procedures that account for approximately 230,000 cases annually in…
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The FDA has issued an early alert for certain Abbott Diabetes Care sensors over incorrect glucose readings, which have been linked to serious injuries and deaths. The Dec. 2 alert applies to about 3 million FreeStyle Libre 3 and FreeStyle…
Medtronic MiniMed has issued a Class II recall of its CareLink Clinic diabetes therapy management software due to incorrect data display. The recall, initiated Oct. 21, affects software version 4.2B, used for continuous glucose monitor retrospective data analysis, according to…
University of California San Diego researchers found hospitals could “significantly reduce surgical waste” by using AI to optimize supply lists, according to a Nov. 26 news release. The study, published in JAMA Surgery, found that auditing surgical preference cards led…
Hospital supply expenses are surging again, signaling that inflationary pressures and utilization trends remain deeply embedded across the industry. Kaufman Hall’s “National Hospital Flash Report” data collected from 1,300-plus hospitals in September and released in mid-November shows sharp increases across…
Dallas-based o9 Solutions, a supply chain artificial intelligence firm, has filed a lawsuit against SAP and three former executives, claiming they conducted a coordinated scheme to steal trade secrets, according to court documents obtained by Becker’s. The lawsuit, filed Nov.…