Medical apps, treatment planning software, and even firmware for ultrasound devices: software is legally classified as a medical device if it is used for medical purposes. This includes diagnosing, ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical ...

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.

SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (ALMDT) announces today that the company has received feedback from the United States Food and Drug Administration (FDA) ...

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both ...

China FDA has issued guidelines on registering medical device software that took effect this month that require detailed reporting as part of registration and supervision. The Chinese-language notice ...