hotspot -WSS

hotspot

author：fashion 2025-09-27 21:27:34 - browse：7956

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： Activists slam private health insurers over coverage restrictions
Next article： VC firm General Catalyst wants to buy a health system

entertainment

WSS

FDA rejects Alnylam's heart disease treatment over insufficient data

7 more heat

Mass General totes up its waste in a move to tackle climate change

Hospitals struggle to profit from CAR

Sana to lay off nearly a third of staff, de

Wife of Gilgo Beach murder suspect files for divorce, court filing shows

hotspot

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+.

hotspot

After affirmative action ruling, medical educators look to 'holistic review'

Wildfires rage amid heat wave in Greece, prompting evacuations and call for European support

Drug repurposing or repositioning? The language matters

DeSantis talks Trump, trans issues and 'what wokeness is'

Duchenne breakthrough therapy leaves behind pioneering families

Affordable Connectivity Program vital to health care, experts say

Drug repurposing or repositioning? The language matters

FDA authorizes Novavax’s updated Covid

United colonoscopy coverage change 'may cost lives,' doctors say

Histogen: Failed biotech offers rare public look inside

Wikipedia

Senate committee advances SCOTUS ethics bill after alleged justice misconduct

Chemotherapy drug shortage eases slightly but still widespread

Chan Zuckerberg Biohub Chicago to focus on inflammation

Why Congress must ban federal programs from using QALYs

In $4.8 billion deal, Bristol Myers Squibb to buy cancer player Mirati

Senate committee advances SCOTUS ethics bill after alleged justice misconduct

hotspot

entertainment

explore

focus