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Medtech Connect Episode 13: Augmented Reality In Surgery

 
• By Hannah Daniel

In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements. 

Medtech Connect
• Source: Citeline/Shutterstock

Further Reading

International Harmonization Has Arrived! FDA Issues Much Anticipated Revamp Of Quality System Regs

Immersive Tech Experts Foresee Bright Future For Apple Vision Pro In Health Care

FDA Launches New Webpage Dedicated To AR And VR Medical Devices

VR Devices Focus Of FDA Patient Engagement Advisory Committee

Market Intel: How Augmented, Mixed And Virtual Reality Tech Unveils New Possibilities For Surgeons

Further Listening

This and all our other podcasts are available on the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

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Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
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FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
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Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

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