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Software › Digital Health › Healthcare

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Foley & Lardner LLP

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

Foley & Lardner LLP on

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more

McDermott Will & Schulte

Digital Health Solutions are Key to Success under Health Care Payment Innovations

McDermott Will & Schulte on

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more

Fenwick & West Life Sciences Group

More Digital Health Device Makers Expected to Seek FDA Clearance

Fenwick & West Life Sciences Group on

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation. Until recently, some investors shied away from companies targeting the...more

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