For example, IEC 62304 Medical Device Software — Software Life Cycle Processes is an international standard that provides a framework for developing and maintaining SaMD and software within ...

The US Food and Drug Administration (FDA) has granted de novo authorisation to Artera’s ArteraAI Prostate software.

Alphabet's life sciences arm Verily laid off staff and eliminated its entire devices program as AI and data infrastructure ...

The Boston wearables firm says the software tool doesn't meet the definition of a medical device and shouldn't be regulated ...

Medtech in 2023 keeps bringing exciting solutions to health challenges, with a range of tools expanding to robotics, smart devices and user data-driven software.

AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision and personalizing treatments at a level that was unimaginable a decade ago.

Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with ...

Median to showcase its artificial intelligence Software as a Medical Device for lung cancer screening at the European Congress of Radiology.

The ArteraAI prostate test uses artificial intelligence and biomarkers to predict if standard hormone therapy will be ...