FDA creates new category for ultrasound pain management device


The US Food and Drug Administration created a new category for ZetrOZ's Acoustic Medicine device

ZetrOZ, a medical technology company that produces wearable ultrasound devices to reduce pain and inflammation, now comes under a new FDA category, created for just these types of therapeuties.

ZetrOZ's sustained acoustic medicine device is an at-home, long-duration ultrasound therapy instrument, where patients, such as teenage and adult athletes recovering from sports injuries get trained on the use of the device, and then can apply it directly at home. The device can treat inflammation, pain, and other unresolved medical issues such as cartilage degeneration, miniscus injuries and ankle sprains. The localized treatment allows healing without a surgical procedure, and is typically applied once a day for 6 to 8 weeks.

The FDA initially cleared ZetrOZ's sustained acoustic medicine device in 2013, with expanded indications in 2020.

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