Oxford Nanopore Technologies plc and Biomérieux SA launched Ampore-TB, a research use only test that can rapidly detect mutations linked to antimicrobial resistance in tuberculosis. With multidrug-resistant TB affecting an estimated 400,000 people annually and increasing risks of morbidity and mortality, this assay could help with earlier diagnosis of drug resistance in patients. Read More
The U.S. FDA’s attempts to harmonize with other nations on quality management received a dose of good news recently when the International Organization for Standards decided to stand pat on ISO 13485, which also leaves the FDA’s Quality Management System Regulation intact. Read More
The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft. Read More
Psychiatry has struggled to enter the precision medicine era. But through a mix of innovations and bootstrapping, progress is coming to the field. Scientists are working on improving diagnoses by investigating potential biomarkers and collection methods. Read More
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqua Medical, Co-Diagnostics, Medical Microinstruments, Polyactiva, Raresight, Xtant Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma Group. Read More
