explore -WSS

explore

author：hotspot 2025-10-02 14:03:26 - browse：2

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： Anesthesiologist group: stop taking Ozempic before surgery
Next article： Treatments for cramps don't cut it. Why aren't there better options?

hotspot

focus

WSS

Meta looks to target Twitter with a rival app called Threads

Surge in Apellis stock fueled by confidence in safety of its eye drug

A new study asks: Are we harming blood donors by taking blood?

Dozens dead from Maui wildfires: What we know about the victims

Community addresses injustice for Long Island mothers

Judge sides with young activists in first

leisure time

explore

This article is exclusive to STAT+ subscribers

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

focus

New air purifier tech could be key to improving indoor air quality

Inside the fall of star MIT scientist David Sabatini

Sports medicine is finally prioritizing gender equality

Bacterial infection may be ‘key event’ in endometriosis, study says

Psychedelics group wrestles with new pharma identity

Van's Gluten Free Original Waffles recalled for possible wheat allergen

Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

Community addresses injustice for Long Island mothers

Continuity nursing helped my family in our darkest PICU moments

Yogurt drink instead of a colonoscopy? CRISPR bacteria are tested

entertainment

Dozens dead from Maui wildfires: What we know about the victims

Patients, digital health players weigh in on FTC's data privacy plan

Senators push IRS to launch nonprofit hospital probe

Health AI: on the border between health care and tech

Bacterial infection may be ‘key event’ in endometriosis, study says

Aspartame and sugar

hotspot

focus

focus

hotspot