Agency’s decision signifies that ZetrOZ’s sustained acoustic medicine technology is safe and effective for promoting injury healing in wider range of medical conditions.
TRUMBULL, CT / ACCESSWIRE / January 9, 2024 / The sam® 2.0 long-duration wearable ultrasound unit from ZetrOZ Systems was cleared by the the U.S. Food and Drug Administration for expanded indications to treat soft tissue injuries and knee osteoarthritis, a decision that will make the sustained acoustic medicine device more readily available to patients with a wider range of medical conditions.
Specifically, sam® 2.0 clinical efficacy studies supported the new FDA indications for the treatment of knee osteoarthritis, upper back myofascial pain, and shoulder, elbow, and ankle tendinopathy.
With its effectiveness documented in more than 40 studies, ZetrOZ Systems’ sustained acoustic medicine has been popular with professional, college and amateur athletes for the treatment of a variety of sports injuries. The FDA’s clearance of expanded indications for the sam® device means it may be safely and effectively used in more conditions that affect the general population. Knee osteoarthritis, for example, affects an estimated 32 million people in the United States.
FDA clearance also has significance for health care providers and health insurance companies, indicating to physicians that they can prescribe the ZetrOZ sam® device with confidence and paving the way for insurers to eventually cover the treatment.
“We’re thrilled that the sam® wearable ultrasound unit is now FDA-cleared for expanded medical indications,” said George K. Lewis, founder and CEO of ZetrOZ Systems. “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.”
The effectiveness of sam® in treating soft tissue and other injuries has been documented in 42 peer-reviewed publications and 20 Level 1-5 clinical studies and is protected by 46 U.S. patents. ZetrOZ’s sam® devices are the only FDA-cleared wearable ultrasound units approved for daily use at home. ZetrOZ’s technology was developed, in part, with funding from the National Institute of Health, National Science Foundation, Department of Defense, and NASA.
For more information on ZetrOZ Systems and the revolutionary sam® 2.0 ultrasound device, please visit www.samrecover.com.
About ZetrOZ Systems
ZetrOZ Systems is leading healing innovations in sports medicine, developing wearable bioelectronic devices for the delivery of sustained acoustic medicine (sam®). Researched and funded by the federal government, ZetrOZ is built on the proprietary medical technology of 46 patents and is the exclusive manufacturer and developer of the sam® product line, which is designed for the treatment of acute and chronic musculoskeletal conditions.
Contact Information
Maria Penaloza
maria.penaloza@newswire.com
SOURCE: ZetrOZ Systems
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