Building FDA submissions like a solid house requires early collaboration, proactive planning, and a clear regulatory story.

Peijia's TaurusTrio TAV system wins NMPA approval, revolutionizing severe AR treatment with Jenavalve's locator technology.

The Senate has rejected bipartisan ACA subsidy bills as millions face doubled premiums when financial assistance expires at ...

The medtech job market faces major shifts in 2026 due to federal layoffs, AI adoption, and M&A activity. Versatile skills ...

Ajinomoto launches CELLiST AAV Production Supplement 1, boosting gene therapy viral vector productivity by 1.3-2x.

CMS AI Playbook v4 mandates prompt safeguards and auditable data lineage for generative AI in hospitals. Non-compliance risks ...

Intuitive's da Vinci SP system secures FDA clearance for hernia, gallbladder, appendix surgeries amid growing competition.

This week's Medtech in a Minute features news about Teleflex and an update on Alcon's efforts to buy Staar Surgical amid ...

Neuralink hires FDA executive David McMullen as head of medical affairs to advance brain-computer interface development.

And each year, MD+DI editors take the time to look at the companies and segments of the industry that have the biggest gains and the biggest losses. This time, we’re looking at the biggest winners in ...

Montagu and Kohlberg will acquire Teleflex Medical OEM for $1.5B in a carve-out deal, closing in 2026. Private equity firms ...

Medical LSR molding simulation prevents defects, reduces costs, and ensures regulatory compliance for device manufacturers.