The US Food and Drug Administration (FDA) has granted marketing authorisation for ActiveProtective Technologies’ (APT) Tango Belt, a prescription-only wearable medical device designed to safeguard older adults from hip fractures caused by falls.
The device, which has gained breakthrough device designation from the agency, is intended as an adjunct to standard care for at-risk individuals.
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According to APT, the belt has shown a 91% decrease in hip fractures that occurred due to falls when used with standard care in a multi-centre premarket trial.
The device detects critical hip-impact falls and is said to deploy airbags to minimise the impact.
It leverages sensors for motion tracking and can be worn both day and night.
Additionally, the device comes with a mobile app that notifies family and healthcare providers in the event of a fall.
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By GlobalDataThe mobile app features a dashboard that provides essential metrics such as adherence and balance.
APT stated that it is looking for senior living operators, healthcare systems and interested providers, especially those involved in value-based care models that screen and intervene for risk mitigation.
With the Tango Belt, the company claims to enable safer mobility and independence for this vulnerable population, addressing a major cause of death and disability among older adults.
ActiveProtective CEO Wamis Singhatat said: “With the FDA’s marketing authorisation and breakthrough device designation of the Tango Belt, we are proud to introduce an innovation that sets a new standard for safer mobility and fall injury mitigation for at-risk older adults.
“This is the culmination of over a decade of unwavering dedication by our team of developers and clinicians. We are grateful to our partners and investors for making this vision a reality.”
