STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter ...

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry ...

Saluda Medical announced that it closed a $100 million financing to support its novel closed-loop, dose-control ...

Just a heads up, if you buy something through our links, we may get a small share of the sale. It's one of the ways we keep ...

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

The Biden Administration has announced the rollout of the “cybersecurity label for interconnected devices, known as the U.S.

The White House this week introduced a voluntary cybersecurity labeling program for technology products so that consumers can have some assurance their smart devices aren't spying on them.

The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...

The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...