United States

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.

Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement. 

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.

Without additional funding from Congress, the FDA’s ORA is facing challenges in retaining and hiring new staff, which will impact inspections, said ORA’s chief Michael Rogers during a webinar. 

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.

Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”

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.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.

A spate of recalls released in recent days follow problems with antibiotic test kits, dialysis tubing, an anesthesia system and infusion pumps. About 4,000 complaints have been reported tied to the recalls.

New guidelines for breast cancer screening age and frequency have been lowered to align with standards from the American Cancer Society, but there are still debates over some of the recommendations. 

The US FDA’s new initiative to create an idea lab for medical device use at home will benefit device manufacturers, patients and policymakers alike.

After much anticipation, the US FDA is set to publish its controversial final rule for regulating laboratory developed tests, which places the tests under the same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.

This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.

The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

People with Parkinson’s often face a “social toll” from the disease, so h2o therapeutics is focused on discreet solutions for the symptom of gait freezing that work with wearable devices.