The PCCP is a framework that allows companies to make modifications to medical devices without needing another FDA submission. This blog outlines how non-AI systems can take advantage of the system to speed up releases.

This post goes into what makes a good medical device submission to the FDA and why Apple gets it right and others get it wrong.

I deep dive into the clinical validation around the recently FDA cleared cuffless BP. monitor by Hilo (previously Aktiia).

Here I deep dive into the Whoop controversy and why the FDA is right.

SpO2 is the most underrated vital. I've reviewed over 1000 hours of raw SpO2 waveforms on very sick patients and SpO2 was the vital the vital that indicated something serious.

This post goes into detail on the issues surrounding current SpO2 monitoring and how to address them.

A deep dive into measuring blood pressure on smart watches and why it is unlikely to be able to.

How will AI disrupt the medical device market business models and why they will change.

How does Generative AI learn and what does that mean for how we use it.

Whats the path to go from 0 to a medical AI being used in the real world.

How do we take an idea for a medical AI, make sure its safe and make the regulators happy.

What are the different regulatory pathways for my medical device and which one applies.