Natural Cycles Fertility App Wins FDA Clearance For Oura Ring Integration

The app, the first to be approved with a birth control indication, can now sync data directly from the Oura Ring, a wearable device that tracks user’s biometrics.

Smiling young woman holding smartphone and wearing Oura Ring.
• Source: Natural Cycles

Women who use fertility management app Natural Cycles can now use an Oura Ring to track their body temperature, putting an end to the need to manually take and record their temperature each day.

That’s thanks to a partnership between Natural Cycles and ŌURA Health announced on 2 August. The US Food and Drug...

More from Regulation

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By 

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

More from Policy & Regulation