The approval was based on the findings from sam 2.0 clinical efficacy studies for the treatment of knee osteoarthritis, upper back myofascial pain, and tendinopathy of the ankle, elbow, and shoulder
sam product range is designed for acute and chronic musculoskeletal conditions treatment. (Credit: Newswire/ ZetrOZ Systems)
US-based ZetrOZ Systems has received expanded indication approval by the US Food and Drug Administration (FDA) for its sam 2.0 long-duration wearable ultrasound unit to treat soft tissue injuries and knee osteoarthritis.
The sustained acoustic medicine (sam) product range is designed for acute and chronic musculoskeletal conditions treatment.
According to ZetrOZ, the approval is expected to make the device easily accessible to patients with a vast range of medical conditions.
The approval was based on the findings from sam 2.0 clinical efficacy studies for the treatment of knee osteoarthritis, upper back myofascial pain, and tendinopathy of the ankle, elbow, and shoulder.
ZetrOZ Systems’ sustained acoustic medicine has been widely used by professional, collegiate, and amateur athletes to treat a range of sports injuries.
The efficacy of the device has been demonstrated in over 40 trials, the American technology company said.
The FDA approval of its expanded indications will allow the safe and effective use of the device in more conditions that affect the general public.
In addition, the approval is important for healthcare providers and health insurance companies, giving doctors the confidence to recommend the ZetrOZ sam devices and opening the door for treatment coverage by insurers.
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 utilize our ultrasound treatment to speed injury healing without the need for oral medication, corticosteroids, or surgery.”
Sam is covered by 46 US patents and is successful in treating soft tissue and other injuries in 20 Level 1–5 clinical studies, 42 peer-reviewed publications, and other settings, said the company.
The device is also said to be the only FDA-approved wearable ultrasound device that is permitted for regular use at home.
The only FDA-approved wearable ultrasound devices that are permitted for regular use at home are ZetrOZ’s sam devices.