6 min read
Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of...
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5 min read
Bob Bouthillier Director, Electrical Engineering, Veranex
4 min read
Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or usability...
6 min read
Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
6 min read
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...
1 min read
No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
2 min read
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022...
2 min read
Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
5 min read
Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While radiofrequency ablation and...
3 min read
The EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of...
