While artificial intelligence can improve upon state-of-the-art diagnostic procedures, such as for detection of breast cancer, it can also promote the broader use of new diagnostic techniques. Recent […]
Read More… from Artificial Intelligence In Ultrasound Diagnostics & A New FDA AI Software Guidance
The historical model of breakthrough medical device and pharmaceutical development is built on the findings of foundational research. An example is the advent of nano-pore […]
Read More… from Leveraging Real-World Data for Foundational Research
Five years ago I wrote about the new MEDDEV 2.7/1 Rev. 4 guidance document for preparing CERs. When that guidance was issued, Notified Bodies widely […]
There was a tragic car crash two months ago involving a Tesla Model S while the driver had the car in its “Autopilot” mode. The […]
Read More… from The Fatal Tesla Crash and Medical Device Risk
Imagine a pioneering surgeon inventor and entrepreneur dedicated to proving that his latest medical device is safe by implanting it within the muscle of his […]
Over 20 years ago, a doctor phones a medical device company’s technical service group from nearly half a world away, and is in a panic. […]
Read More… from Can You Reduce Device Risk Just By Informing the User?
