The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation ...

President Trump’s 2025 executive order establishing artificial intelligence (AI) in pediatric cancer as a national priority marks a turning point in medicine. For decades, childhood cancer treatments ...

The Service+Tech model embeds AI into the workflow of regulatory experts rather than treating technology as a standalone tool; an approach allowing organizations to adopt AI immediately, with no risk ...

The collaboration aims to deliver real-time image processing, robotic control and cloud-enabled intelligence in a unified architecture. “By powering our visualization, control and secure cloud ...

Rejected by leading customers Physicians as customers/intermediary complicates adoption pathways. Emerges in niche/small markets Sophisticated epidemiology and real-world data allow larger initial ...

For over three decades, Sunrise Labs stood at the forefront of engineering excellence and medical innovation. Today, the company unveils its new identity: Suntra MedTech Solutions™, a bold evolution ...

Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial ...

Having enjoyed tremendous success and growth in value-based care models, I am passionate about helping other primary care practices thrive in the shifting healthcare climate. I help healthcare ...

A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting ...

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, ...