In July 2025, FDA told WHOOP that its Blood Pressure Insights feature was an unauthorized medical device. WHOOP disputed FDA’s position and kept selling it. In January 2026, while the dispute was still open, FDA reissued its general wellness guidance. FDA closed the warning letter in June after WHOOP modified the feature and its labeling.
Working through this question for your own product? Request a call with DCN Dx:
https://dcndx.com/wellness
In this episode of Expert Insights, Emily Friedland talks with Blythe Karow, Founder and CEO of The Karow Advisory Group, and Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, about where a product intended for wellness becomes a regulated medical device and why the same line-drawing questions apply to at-home diagnostics. They discuss how risk, intended use, claims, form factor, and presentation can shape FDA’s view of a product.
DCN Dx offers a fixed-fee Wellness Regulatory Assessment. In two to four weeks, you receive a written assessment of how FDA’s current general wellness policy may apply, the likely regulatory path, and whether FDA contact is warranted.
WHAT YOU’LL HEAR IN THIS EPISODE
- What FDA’s January 2026 guidance clarified for noninvasive sensing functions such as blood pressure, and Blythe’s view of its effect on the modified WHOOP feature
- Why a patch that uses a subcutaneous needle falls outside FDA’s low-risk general wellness policy, whatever the marketing language
- Dan’s experience with FDA 513(g) responses for at-home lateral flow assays proposed for wellness uses
- How a claims matrix, a tiered review process, and rules for influencer content can keep marketing language from crossing into medical-device claims
- Blythe’s read on the WHOOP warning letter, the stoplight-color dispute, and the risks of bundling a wellness feature with two cleared medical-device features
Full transcript and show notes:
https://dcndx.com/insights/technically-wellness-gray-zone-between-consumer-health-regulated-diagnostics/
GUESTS
Blythe Karow | Founder and CEO, The Karow Advisory Group
Blythe is a MedTech strategist with twenty-five years across medical devices, wearables, and regulated health technology. She founded The Karow Advisory Group, where she advises CEOs, investors, and executive teams on product strategy, commercialization, and U.S. market entry, from early-stage startups to Fortune 50 companies. She was previously Co-founder and CEO of Evren Technologies, where she led the Phoenix transcutaneous vagus nerve stimulation device to FDA Breakthrough Device Designation in 2021, and Head of Digital Health Strategy for spinal cord stimulation at Boston Scientific. She writes The Device Files, a widely read Substack on MedTech strategy and the regulation of wearables and consumer health, whose readership grew sharply through her coverage of the WHOOP case. She is an Entrepreneur in Residence at Yale and holds a biomedical engineering degree from Johns Hopkins and an MBA from the University of Virginia’s Darden School.
Dan Simpson, RAC | Director of Regulatory Affairs, DCN Dx
Dan is Director of Regulatory Affairs at DCN Dx and a RAC-credentialed, ASQ-certified medical device auditor with more than 15 years in IVD and medical device regulatory and quality roles. Before DCN Dx he led regulatory affairs at ERI Group and spent 14 years running quality and regulatory affairs at Corgenix Medical Corporation. He works with IVD manufacturers on FDA 510(k), De Novo, and PMA submissions as well as IVDR conformity assessment, across point-of-care, OTC, companion diagnostics, and high-complexity assays.
HOST
Emily Friedland | VP of Clinical Research, DCN Dx
ABOUT DCN DX EXPERT INSIGHTS
DCN Dx Expert Insights examines the technical, regulatory, clinical, and manufacturing decisions that shape the development and commercialization of in vitro diagnostics.
