Author name: Leonardo Arias

Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.

Humana is giving investors an early look at stars data after a CMS slip-up led some information to be inadvertantly shared online. The results are in line with expectations but still unsatisfactory, Humana said.

Implementing artificial intelligence requires significant human labor and technical expertise, threatening to create a digital divide between highly resourced health systems and safety-net providers.

The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for growth.

The coverage landscape for the privatized Medicare plans will look significantly different next year, giving smaller players a chance to snap up market share but likely creating confusion for seniors.

Regulatory documents show how 89bio’s board pushed Roche hard for a deal valued at $20 per share in upfront and milestone payments.

“We’ve worked hard, but have not made as much progress as is needed,” CFO Daniel Morissette said about the company’s 2025 financial results.

In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.

Looking for a biopharma job in Boston? Check out the BioSpace list of six companies hiring life sciences professionals like you.

The clearance gives Distalmotion, which sees opportunity in ambulatory settings, a third robotic procedure category in the U.S. Elsewhere, AiM Medical Robotics raised $8.1 million.