FDA

FDA approves 'smart belt' to prevent hip fractures

April 16, 2025

ActiveProtective received FDA marketing authorization for the Tango Belt, a wearable device designed to prevent fall-induced hip fractures in older adults, that uses sensors to monitor motion and deploy airbags during serious falls. In a multicenter premarket clinical study (NCT05245097), the device demonstrated a 91% reduction in hip fractures compared with standard care alone. Tango Belt, which received Breakthrough Device Designation by FDA, is intended to be used alongside standard care to enhance fall injury prevention. The prescription-only belt can be worn day and night and includes a companion mobile app that alerts family and care staff when a fall is detected. According to its news release, ActiveProtective is now seeking partnerships with senior living facilities and healthcare providers to implement this innovative solution.

Sources:

(2025, April 9). FDA. Device Classification Under Section 513(f)(2)(De Novo). DEN240021. Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240021

(2025, April 15). ActiveProtective Technologies, Inc. ActiveProtective Receives FDA Market Authorization for the Tango Belt, a Breakthrough-Designated Wearable Device for the Prevention of Fall-Induced Hip Fractures in Older Adults. [Press release]. https://www.tangobelt.com/articles-2/2025/4/15/activeprotective-receives-fda-market-authorization-for-the-tango-belt-a-breakthrough-designated-wearable-device-for-the-prevention-of-fall-induced-hip-fractures-in-older-adults