Aggregator

Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial Intelligence (AI) , in particular, is playing an increasingly critical role in helping manufacturers meet expanding regulatory expectations.

The post Beyond Automation: How AI Transforms Clinical Evaluation Reports into Strategic Regulatory Assets appeared first on MedTech Intelligence.

The physician has a unique perspective that non-clinical investors don’t: they know firsthand whether a technology will be adopted. They deeply understand if it truly is better for them and their patients.

The post Physician Investment in MedTech Startups Can Be a Tricky Topic appeared first on MedTech Intelligence.

A new EU Commission study on the Deployment of AI in Healthcare makes one thing crystal clear: AI isn’t just a buzzword, it could be the lifeline our systems desperately need.

The post AI in Healthcare – The EU’s Biggest Opportunity & Challenge appeared first on MedTech Intelligence.

Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and intermediate-risk patients with symptomatic, severe aortic stenosis.

The post Expanded approval for Navitor TAVR system – CE Mark in Europe appeared first on MedTech Intelligence.

Company says the system empowers clinical teams to respond to surges, track usage and ease workflows with user-friendly touchscreen technology for telemetry patients on the move.

The post Philips launches smart telemetry platform for cardiac connectivity beyond the bedside appeared first on MedTech Intelligence.

The Globe System, according to the company, achieves highly durable lesions and an excellent safety profile, together with integrated high-density mapping and true single-shot PVI for treatment of atrial fibrillation.

The post Globe® Pulsed Field System receives FDA approval appeared first on MedTech Intelligence.

We stopped squeezing every last patient slot out of our clinicians. Here’s what happened...

The post Curing the ‘Volume-based care’ model appeared first on MedTech Intelligence.

The rise of AI-powered health apps that claim to diagnose conditions in real time is transforming how we approach healthcare. From symptom checkers to wearable ECG monitors and AI stethoscope apps, these tools promise early diagnoses and personalized healthcare at our fingertips. What if they go wrong?

The post How AI health diagnostics could save lives – or create new risks appeared first on MedTech Intelligence.

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 collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.

The post Impact of Combination Products on the Medical Devices Industry Copy appeared first on MedTech Intelligence.