hotspot -WSS

hotspot

author：knowledge 2025-10-01 18:23:15 - browse：6323

Person wearing a smart watch. -- first opinion coverage from STAT — Adobe

The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.

Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.

The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Sports medicine is finally prioritizing gender equality
Next article： Former reverend arrested for allegedly killing 8

WSS

Steward Health Care has deal to sell doctor network to UnitedHealth

Will generative AI in health care meet the fate of IBM's Dr. Watson?

What to watch for from Zogenix and Amicus clinical trials

The haunting brain science of long Covid

Will the FTC rein in IQVIA's health data empire?

Roche subsidiary Foundation Medicine opens new headquarters

Wikipedia

hotspot

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

knowledge

DIEP, the 'gold standard' of breast reconstruction, is under threat

Readout Newsletter: Merck, Vertex, and Viking updates

Trump demands the U.S. pay no more for drugs than other countries … again

Supreme Court mifepristone arguments center on docs' right to sue

Duchenne breakthrough therapy leaves behind pioneering families

How doctors’ personal politics affect patients

Jerome Adams on the need for new antivirals for Covid

Roche subsidiary Foundation Medicine opens new headquarters

23andMe had bad news about my health. I wish a person had delivered it

Covid vaccine financial winners and losers, from Pfizer to Novavax

Wikipedia

UHS says company favors patients whose insurance pays more

Abortion pill case raises question: who can sue the FDA?

Truvian presents data for its desktop blood

Food as medicine: Medically tailored meals may get standardized

States should stop sabotaging methadone treatment reform

Vertex Pharmaceuticals may move headquarters in Boston

explore

leisure time

explore

leisure time