Lab IoT adoption is growing, and recent innovations make it more promising than ever. See how IoT advances can unlock new ...

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries.

Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching ...

Angioplasty and stenting procedures (or percutaneous coronary interventions/PCIs) are performed more than four million times around the world every year to open up blockages in coronary arteries to ...

Wearables are changing the game for health monitoring. From smartwatches and rings to skin patches, glasses, and even bras, companies are in a race to bring the latest innovations to market. But as ...

Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a potential ban across the European Union. Such a ban would introduce a need ...

Introduction: A Wake-Up Call from Recent History In the world of MedTech, traditional development processes often slow down innovation. Medical device manufacturers face an environment where global ...

As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with ...

Cardiovascular conditions are the leading cause of death. Fortunately, industry leaders are discovering innovative ways to diagnose and treat them. See how mobile apps and AI will change this field in ...

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The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would ...