Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Outlook, Roche, Uroviu, Zenflow, Zoll.
Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills.
Rhythm Diagnostic Systems SAS (RDS) raised €14 million (US$16.6 million) in a series A funding round for Multisense, its wearable device that continuously monitors key physiological parameters of patients in hospital or at home. Already CE-marked and deployed in approximately 15 hospitals across France, Belgium and Germany, the funds will enable RDS to expand its commercial and customer support teams and prepare reimbursement filings in key European markets, Elie Lobel, CEO of RDS, told >BioWorld.
Up to 71% of people carry at least one pathogenic variant that could contribute to development of a heritable disorder in offspring, but until now, prospective parents often had to undergo multiple tests to understand their risks. Pacific Biosciences of California Inc. (Pacbio)’s expanded Puretarget portfolio provides a quicker and more streamlined solution as it covers all challenging tier 3 genes identified in the American College of Medical Genetics technical standard.
Bard Peripheral Vascular Inc., agreed to pay $7.2 million to settle allegations that two photoplethysmography products it distributed were the subject of illicit Medicare claims, a problem the company inherited when it decided to do business with Semler Scientific Inc. of Campbell, Calif.
The U.K. National Institute for Health and Care Excellence unveiled a plan that is designed to provide less cumbersome market access for medical technologies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aria Diagnostics, Electrocore, Eli Lilly, Embleema, Hologic, Minicarm.com, Resonetics, Tandem, Vivos.