Carr Tech Corp, a Maryland-based medical device startup founded by pharmacist-turned-entrepreneur Sue Carr, proudly announces ...

CGBIO(CEO Hyun Seung Yu), a leading Korean company specializing in bio-regenerative medicine, proudly announces that its ...

Tim Boreham sharpens his knifes to look under the hood at cardiac pacing device innovator EBR Systems after its US FDA ...

The legislation would allow the FDA to approve drugs and devices that have already been approved in other industrialized ...

HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...

The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among ...

Alibaba Group's Damo Academy has received FDA endorsement for its AI-powered cancer detection tool, marking a significant ...

Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...

After 20 percent of the agency’s work force was cut, federal health officials have decided to bring back some experts and ...

When developing clinical tools, it's essential to prioritize clinical relevance. Get experienced clinicians involved early in ...

U.S. Food and Drug Administration approvals ... the agency's premarket approval database. Devices approved for commercialization under this rigorous process include Medtronic's adaptive technology ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...