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Wire · opportunities

FDA digital health leader departs after 21 years

8 September 2026 · By · Wire by Fusion42

Published

8 September 2026

Topic

opportunities

◆ Sectors

Healthtech Infrastructure

◆ Geography

United States

◆ Source

Read at beckershospitalreview.com →

◆ Verified

Fusion42 · 9 September 2026 · Fusion42 review

Anindita Saha, leader of the FDA's Division of Digital Health Outreach and acting associate director for data science and AI policy, has left the agency after over 21 years, marking a significant leadership change in the FDA's Digital Health Center of Excellence which directs regulation of software as medical devices, wearables, and AI-enabled tools.

This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure.

◆ ◆ The Wire takeaway

Leadership turnover at the FDA's digital health unit means regulatory approaches might shift, so you need to reassess your compliance and engagement strategies now to retain market access in US digital health.

◆ Coverage

1 source · 8 Sep 2026

◆ Related on Wire

◆ Topics

Healthtech Infrastructurefdadigital-healthai-policyhealthtechregulatory-change