Wearables Hit $93B Market
The wearables market reached $93 billion with projections to surpass $200 billion by 2033, led by Aura expecting $1 billion revenue in 2025 — double the previous year. HHS Secretary RFK Jr. champions wearables under the 'Make America Healthy Again' agenda, with January 2026 regulations reclassifying most devices as 'general wellness products' for easier oversight. Aura ramped up lobbying spending to over $1 million in 2024.
The broader wearables market is dominated by established tech giants. In the second quarter of 2025, Apple, Huawei, Samsung, and Xiaomi were among the top five companies in terms of units shipped worldwide. Ear-worn devices represent the largest share of shipments, accounting for over 60% of the market, while smartwatches contribute a significant portion with over 38 million units shipped in the same period. The "Make America Healthy Again" (MAHA) initiative is a wide-ranging public health movement championed by HHS Secretary Robert F. Kennedy Jr. Established by executive order in February 2025, the MAHA commission focuses on the root causes of chronic illness, scrutinizing diet, environmental chemicals, and overmedicalization. Kennedy has stated a vision of having every American using a wearable device within four years. The January 2026 deregulation significantly expands the FDA's definition of "general wellness products." This change allows devices using non-invasive sensors to estimate physiological parameters like blood pressure, oxygen saturation, and blood glucose without undergoing stringent medical device oversight, provided they are marketed for wellness purposes. This policy shift follows previous regulatory friction. In July 2025, the FDA issued a warning to wearable brand WHOOP, asserting that a feature estimating blood pressure blurred the line between a wellness tool and a medical device, which is the type of regulatory obstacle the new guidance aims to remove. Aura's rapid growth has been fueled by significant sales and investor confidence. The company has sold over 5.5 million rings since its founding in 2015, with more than half of those sales occurring in the last year alone. A recent $900 million funding round boosted the company's valuation to approximately $11 billion. While the government push aims to increase adoption, it raises significant data privacy questions. Health information collected by most commercial wearable apps is not protected by the Health Insurance Portability and Accountability Act (HIPAA), leaving concerns about how consumer data is collected and shared unresolved.
