Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

When development efforts aren't well managed, appropriately documented, or realistically planned, a company's most innovative product ideas might never make it to market. Brian Kelleher By some ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

WOODBURY, Minn--(BUSINESS WIRE)--A first for the medical device development industry, I-Tek Medical, a Minneapolis, Minnesota based medical device contract manufacturing company, has joined forces ...

Flywheel, the leading medical imaging data management and analysis platform, today announced key milestones achieved in 2025. The company also recently closed on an oversubscribed $25 million ...

While artificial intelligence is a word heard in many industries, investors might be surprised that its use is growing in medical devices, diagnostics, and even drug development. Indeed, in 2022, the ...

“We are excited to commence this critical development with SynCardia, a highly regarded global leader in advanced heart replacement technology,” said Gavin Coote, Executive Chairman of Hydrix. “It ...

The French clinical stage company focused on cardiac innovation received the funds from a Series C funding round and the EC’s ...