FDA Authorizes Breakthrough Tango Belt Device That Reduces Hip Fractures by 91% in Older Adults
核心洞察
ActiveProtective (搜索) has received FDA marketing authorization for the Tango Belt (搜索), a wearable device that deploys airbags during falls to protect older adults from hip fractures.
In a multicenter clinical study, the prescription-only Tango Belt (搜索) demonstrated a remarkable 91% reduction in fall-induced hip fractures when used alongside standard care protocols.
The device, which earned FDA Breakthrough Device Designation, features motion-tracking sensors and a companion app that alerts caregivers when falls occur, potentially transforming fall prevention in at-risk elderly populations.
ActiveProtective (搜索) Technologies Inc. (APT) announced on April 15, 2025, that it has received U.S. Food and Drug Administration (FDA) marketing authorization for its Tango Belt (搜索), a wearable medical device designed to prevent hip fractures in older adults at risk of fall-related injuries.
The Tango Belt (搜索), which previously received FDA Breakthrough Device Designation, is now authorized as a prescription-only device intended to be used as an adjunct to standard care for reducing hip fracture (搜索) or dislocation risk in vulnerable elderly populations.
Revolutionary Technology Shows Exceptional Clinical Results
The innovative device utilizes specialized sensors to monitor motion and automatically deploys airbags during serious hip-impacting falls. In a multicenter premarket clinical study, the Tango Belt (搜索) demonstrated remarkable efficacy, achieving a 91% reduction in fall-induced hip fractures compared to standard care alone.
"Today marks a crucial step forward in addressing fall-induced hip fractures, a devastating injury that impacts countless lives of older adults every year," stated Wamis Singhatat, CEO of ActiveProtective (搜索). "With the FDA's marketing authorization and Breakthrough Device Designation of the Tango Belt (搜索), we are proud to introduce an innovation that sets a new standard for safer mobility and fall injury mitigation for at-risk older adults."
Practical Design with Connected Features
The Tango Belt (搜索) has been engineered for practical daily use, with a design that allows it to be comfortably worn both day and night. The device is complemented by a companion mobile application that automatically alerts family members and care staff when a fall or impact is detected.
The mobile app features an intuitive dashboard that displays important metrics including balance confidence and adherence, providing caregivers with valuable insights into the wearer's mobility patterns and potential risk factors.
Addressing a Critical Healthcare Challenge
Hip fractures represent one of the most serious fall-related injuries for older adults, often leading to significant disability, loss of independence, and increased mortality. The economic burden of hip fractures on the healthcare system is substantial, with extensive hospitalization, rehabilitation, and long-term care costs.
The Tango Belt (搜索) aims to address this critical healthcare challenge by providing a proactive intervention that can significantly reduce the incidence of these devastating injuries. By preventing hip fractures before they occur, the device has the potential to preserve quality of life for older adults while reducing healthcare expenditures associated with fall-related injuries.
Market Strategy and Availability
ActiveProtective (搜索) is now seeking partnerships with senior living owner/operators, healthcare systems, and providers, particularly those operating under Value-Based Care models that emphasize proactive risk screening and intervention strategies.
The company's focus on these healthcare segments aligns with growing industry trends toward preventive care approaches that aim to mitigate risk and avoid costly episodes of care, particularly for vulnerable elderly populations.
Development Background
The Tango Belt (搜索) represents the culmination of over a decade of research and development by ActiveProtective (搜索)'s team of developers and clinicians. The company's mission centers on redefining the standard of care for preventing fall injuries in at-risk older adults, with an initial focus on hip fractures as a leading cause of disability and death.
"This is the culmination of over a decade of unwavering dedication by our team of developers and clinicians," Singhatat noted. "We are grateful to our partners and investors for making this vision a reality."
Clinical Implementation Considerations
Healthcare providers considering implementation of the Tango Belt (搜索) should note that the device is intended as an adjunctive therapy to be used alongside existing fall prevention protocols and standard care practices. The company advises that users refer to the instructions for use supplied with the device for complete information on indications, contraindications, warnings, and precautions prior to implementation.
As the aging population continues to grow globally, innovative technologies like the Tango Belt (搜索) may play an increasingly important role in addressing the challenges of fall-related injuries and supporting healthy aging in place for vulnerable older adults.