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Regulatory Oversight › Medical Devices › Technology

McDermott Will & Schulte

FDA teases faster approval times with new agency-wide AI tool

McDermott Will & Schulte on

The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces AI Councils Amid Calls for Greater Agency Transparency

Akin Gump Strauss Hauer & Feld LLP on

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more

Faegre Drinker Biddle & Reath LLP

Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Faegre Drinker Biddle & Reath LLP on

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more

Hogan Lovells

"Make in India" Initiative Extends to Medical Devices - India's New Medical Device Rules Are Now in Effect

Hogan Lovells on

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more

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