The Medicare coverage story of the Cardiomems device has a Homeric air about it, spanning nearly a decade starting with an adverse local coverage determination in 2016. Abbott Park, Ill.-based Abbott Laboratories finally brought the story full circle with a successful national coverage determination that gives the device nationwide coverage for Medicare patients without the need to wrangle with Medicare administrative contractors. Read More
A global commission has proposed a fundamental change to the way obesity is defined and diagnosed. If the change is implemented, obesity would be considered a health risk in some contexts, and a disease in others. “The commission is reframing obesity... in a way that allows for the nuanced reality of obesity,” Robert Eckel told reporters at a press briefing announcing the proposal, which was published online in The Lancet Diabetes & Endocrinology on Jan. 14, 2025. Read More
Natera Inc., a developer of cell-free DNA testing, provided an update on its product portfolio at the J.P. Morgan Healthcare Conference on Jan. 15. The company disclosed a new version of the Signatera assay that leverages the genome. Natera said the test, now available for research and clinical use, enables bespoke assay design from a whole genome sequence of a patient’s tumor. Read More
Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal. The U.S. FDA recently provided a glossary of terms under the heading of recall – a move that comes short of industry’s preference that the term be jettisoned altogether. Read More
Esocap AG aims to transform the treatment of eosinophilic esophagitis with its drug delivery technology, ESO-101, designed to increase mucosal contact time and drug deposition in the esophagus. Data from the recent ACESO study showed that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in patients with active eosinophilic esophagitis. Read More
BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the financing trends of the past year and the regulatory actions likely to affect med-tech into 2025. Read More
BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alamar, Buttium, Firefly Neuroscience, GE Healthcare, Guardant, Helix, Henry Schein, Intech, Kryptos Biotechnologies, Lady Technologies, Microbix, Microsoft, My Own Med, Nextbiomedical, Nextstim, Nvidia, Pison, Resolve Surgical, Respondhealth, Sapient, Siemens Healthineers, Sinaptica, Smith & Nephew, Stmicroelectronics, Synchron, Tyber Medical, Vaxxas, Virtuoso, Visby, Viz.ai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobot Surgical, Icotec. Read More
