The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.

A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.

GE HealthCare announced today a new investigational MRI, which will be used in collaboration with researchers at Boston’s Brigham and Women’s Hospital, promises to help researchers better understand complex neurological diseases.

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.

GE HealthCare announced today a new investigational MRI, which will be used in collaboration with researchers at Boston’s Brigham and Women’s Hospital, promises to help researchers better understand complex neurological diseases.

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.

Front Line Medical Technologies Inc.'s new CE marking expands access of its occlusion device COBRA-OS to medical providers in Europe. Adam Power, chief medical officer at Front Line Medical, talked to Medtech Insight about their marketing plans and benefits of the technology. 

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.