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6 must-have properties of AI as a Medical Device and how to approach the FDA guiding principles
In the ever-evolving landscape of modern healthcare, a profound transformation is taking place at the intersection of...
Developing Machine Learning-enabled digital medicine – Sleep Management case study
Foreword: the growing need for advanced digital healthcare As healthcare faces mounting pressures, there is a growing...
The Medtech Conference 2022 – Top 5 issues for new product innovation
Every year Sagentia Innovation participates in The Medtech Conference, Boston, and Rob Morgan, VP Medical, would like...
When should you contact FDA about a new medical device?
Medical device companies often ask us about the best time to contact FDA for regulatory guidance. There’s a delicate...
FDA IVD review process has changed; how should manufacturers adapt?
A surge in premarket submissions during Covid-19 led the FDA to realign its review process for IVDs. Consequently, many...
Holding medical devices hostage
As medical devices become increasingly connected, security is emerging as a major issue, prompting device companies and...
How 3D printing could be shaping our bodies and our futures
The recent guidelines released by the FDA are confirmation of a growing industry which incorporates 3D printing into...
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