The Food and Drug Administration cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.
iRhythm’s Zio AT design changes win FDA clearance Read More »
Demand for the pulsed field ablation device drove the company’s electrophysiology sales up 177% in the third quarter compared to a year ago.
Boston Scientific boosts PFA expectations, citing rapid Farapulse adoption Read More »
Centene is emulating other insurers unhappy with how regulators handled quality ratings for 2025. The flurry of complaints is “symptomatic of what appear to be systemic issues” with CMS calculations, Centene said.
Centene sues HHS over Medicare Advantage star ratings fall Read More »
The company committed to closing the facility, which makes breast health products, in late 2021 and gave most employees the option to relocate to other sites.
Hologic to lay off 86 people in closure of Connecticut facility Read More »
Healthcare organizations will need to test models in their local environments, keep an eye on performance and work together on implementing the technology, panelists said at HLTH.
Thoughtful implementation, ongoing monitoring key to safe health AI Read More »
In the battle over drug prices, one sector of the healthcare industry has risen above all the players as the boogeyman: pharmacy benefit managers. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the lens now focused on PBMs’ business practices.
Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo.
Roche Beats Q3 Sales Estimates as CEO Voices Opposition to Novo Holdings-Catalent Merger Read More »
Yet another therapy with FDA accelerated approval suffers a setback; Sage’s tough year continues; Sanofi drops $326 million in radiopharma while selling its consumer health unit; Novo Nordisk’s positive Rybelsus results in cardiovascular disease; and more.
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
Novo Makes Case to FDA That Semaglutide is Too Complex for Compounders to Produce Read More »
The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.
