Article source: Global Regulatory & Consumer Insights
New Zealand medical tech startup Alimetry has claimed an FDA approval for a wearable device that can be used to diagnose gastric disorders non-invasively.
The Gastric Alimetry device will be marketed and distributed in the US by a new Minneapolis-based subsidiary, said the company, which has also secured approval for the product in New Zealand as well as the UK.
The device (pictured above) – Alimetry’s first commercial product – uses a stretchable high-resolution sensor to non-invasively map digestive patterns by measuring electrical signals through the skin, and delivers clinical reports via the cloud to inform the diagnosis and classification of gastric disorders.
Gastric Alimetry is due to be launched in the US next month, with the help of a recent fundraising at the Auckland company which raised NZ$16 million (around $10 million). It has also had a limited rollout in New Zealand and the UK.
The testing is performed in a clinical setting, rather than at home, with recordings from the skin surface taken before and after a meal while patients log symptoms into a companion app.
“Diagnosing gastric symptoms has been a deeply challenging clinical problem,” said Alimetry’s chief executive and founder Greg O’Grady, a professor of surgery at the University of Auckland.