Digital

“We remain fully committed to the integrated growth strategy that has enabled us to deliver significant growth and value creation, over the better part of the past decade,” says CEO Shailesh Jejurikar as firm reports net sales up 1% in latest quarter.

Medable pivots to agentic AI targeting clinical development's 80% manual labor bottleneck, aiming to double CRA efficiency and unlock capacity for 9,000 waiting drug candidates.

FDA updates pair of guidance documents relaxing its posture on how it regulates general wellness devices and clinical support software. Industry mostly welcomes changes, agreeing with agency’s view that lighter regulation will help spur innovation.

FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.

India’s moves on digital data protection don’t pose a hurdle to patient recruitment, but on the wish list of global innovators is permission for first-in-human (FIH) trials and removal of certain commercialization requirements, says Parexel’s India head

During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.

The rise and fall of US tariffs and the chill headwind from China’s state procurement policies have blown onto medtech’s radar. But how to monetize AI is the dominant concern up and down the industry.

Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.

The rise and fall of US tariffs and the chill headwind from China’s state procurement policies have blown onto medtech’s radar. But how to monetize AI is the dominant concern up and down the industry.

During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?