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Las matemáticas, a menudo percibidas como una disciplina abstracta, están en el corazón de la lucha contra las enfermedades. Desde la predicción de epidemias hasta la personalización de tratamientos, los números y las fórmulas se han convertido en her …

A 510(k) submission now planned for this quarter sets up a potentially faster clearance than the de novo pathway originally planned, the company said.

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.