The De Novo classification pathway provides a streamlined FDA approval process for novel medical devices.

IoT enables these devices to collect real-time data, transmit it to healthcare providers, and even make autonomous decisions!

We are proud to announce that Rx Device Consulting played a key role in securing FDA clearance for Happy Health's "Happy Ring."

Neurostimulation devices are at the forefront of innovation in treating neurological disorders, offering promising new treatments!

AI-powered SaMD products are designed to perform a variety of medical functions, from diagnosing diseases to recommending treatment plans.

AI has the ability to more quickly, precisely, and accurately process vast amounts of data and support the development of diagnostic tools!

This article explores key components and recent advancements in regulatory strategy development for medical devices.

Our recent collaboration involved a cardiology startup identifying critical lesions to facilitate precise placement of cardiac stents.

Our recent collaboration involved an international startup developing a digital health device for obstructive sleep apnea (OSA) / snoring.

One of our recent collaborations involved a pioneering startup focused on developing a wearable device for epilepsy management.

Our recent collaboration involved a groundbreaking neurology startup developing a portable device capable of quantifying CNS reflex time!