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Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

 
• By Derrick Gingery

Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.

artificial intelligence
THE FDA ALSO IS PART OF THE COALITION FOR HEALTH AI, WHICH IS WORKING TO ADVANCE THE TECHNOLOGY IN HEALTH CARE. • Source: Shutterstock

Identifying and fighting bias in artificial intelligence will be one of many priorities for the US Food and Drug Administration going forward as it enhances its regulatory capacity for the technology.

The FDA’s drug, biologic, and device centers, as well as its Office of Combination Products, will collaborate to ensure regulatory...

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Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 
• By Natasha Barrow

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

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• By Shubham Singh

Corify Care’s CEO said the company aims to submit its 510(k) application to the US FDA by year-end, targeting market clearance in 2026. The company hopes its collaboration with the Mayo Clinic will help speed adoption of ACORYS, a noninvasive mapping technology for use in complex cardiac ablations.

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• By Marion Webb

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.

UK Center To Develop Brain Stimulation Devices Opens

 
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Backed by £50m of UK government funding, the new research center will delve into neural dynamics to develop novel devices ranging from brain implants to wearables.

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No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
• By Marion Webb

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.

UK Center To Develop Brain Stimulation Devices Opens

 
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Backed by £50m of UK government funding, the new research center will delve into neural dynamics to develop novel devices ranging from brain implants to wearables.

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.