Insights on Longevity & Healthspan

On January 6, the US Food and Drug Administration (FDA) released two significant updates potentially important for companies operating in the consumer health technology space.

The Centers for Medicare & Medicaid Services (CMS) Innovation Center has announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, a 10‑year voluntary payment model that introduces outcome‑aligned payments (OAPs) to expand access to technology‑supported care for Medicare beneficiaries with common chronic conditions.

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care.

A putative class action against Whoop, the wearable technology company, uses the US Food and Drug Administration’s (FDA) July 2025 warning letter regarding its new blood pressure product feature as a litigation springboard. The case shows how misalignment with regulators’ expectations can quickly cascade from agency scrutiny to consumer litigation.

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication.

When one hears the term “neural data,” a brain implant comes to mind, alongside concerns about these neurotechnologies being able to read our innermost thoughts.