The US Food and Drug Administration (FDA) has granted clearance to ZetrOZ Systems’ sustained acoustic medicine device, the sam 2.0 wearable ultrasound unit, broadening its use for various medical conditions.
ZetrOZ’s sam is a low-intensity, long-duration, daily ultrasound treatment designed to reduce the need for surgery and pain medication.
The latest decision by the FDA marks a significant step in making the technology more accessible for patients suffering from soft tissue injuries and knee osteoarthritis.
Efficacy trials of the device supported the latest FDA indications for treating knee osteoarthritis, upper back myofascial pain, and tendinopathy in the shoulder, elbow, and ankle.
ZetrOZ Systems’ medicine technology, documented in more than 40 studies, has been widely used by athletes across different levels for sports injury treatment.
The FDA’s clearance extends the device’s application to more common conditions, potentially benefiting the 32 million individuals in the US affected by knee osteoarthritis.
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ZetrOZ Systems founder and CEO George Lewis said: “We’re thrilled that the sam wearable ultrasound unit is now FDA-cleared for expanded medical indications.
“Dozens of studies over the last decade have shown that our sustained acoustic medicine technology effectively treats numerous types of injuries. This FDA clearance will make it easier for doctors and their patients to utilise our ultrasound treatment to speed injury healing without the need for oral medication, corticosteroids, or surgery.”
Said to be the only FDA-cleared wearable ultrasound unit approved for daily home use, the sam 2.0 device is protected by 46 patents in the US and documented in 42 peer-reviewed publications and 20 clinical studies across various levels.
The development of ZetrOZ’s technology was partially funded by institutions, including the National Institute of Health, the National Science Foundation, the Department of Defense, and Nasa.