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Saturday, July 20, 2024 6:50:18 PM
It is indisputable that the CMS has approved one device for the NOPAIN Act. We proved that with links. The ActiPatch / RecoveryRx device is not approved by the CMS for the NOPAIN Act. Why not? Those BIEL survey studies were published in 2015 and 2019 so what's the holdup? If the BIEL survey studies satisfy the CMS, shouldn't RecoveryRx be cleared already?
Unless BIEL Management is inept and they haven't contacted the CMS? Is THAT your explanation? If not, what is YOUR explanation -- why isn't RecoveryRx cleared by the CMS for the NOPAIN Act yet?
("Seasoned researchers?" Rawe, Staelin, and Koneru? You realize that if independent researchers hadn't done knee osteoarthritis and plantar fasciitis studies, the device STILL wouldn't have FDA clearance for OTC pain, because the FDA rejected the 510(k) applications submitted with only studies from Rawe Staelin and Koneru?)
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