Tag: DeltaWave
REMSleep names new CEO
March 11, 2026HME News Staff
BLACKSHEAR, Ga. – REMSleep has announced the passing of its founder and CEO, Thomas Wood, and the appointment of its new CEO, Jeffrey Marshall. Wood, who founded REMSleep and served as chairman of the board and CEO, passed away on Feb. 26. "Tom was more than a founder, he was a visionary and patient advocate who believed that sleep apnea patients deserved better options," said Anita Michaels, who has been elected chairman of the board. "He spent years raising funding to build...
REMSleep secures coding approval for DeltaWave
February 2, 2026HME News Staff
BLACKSHEAR, Ga. - REMSleep Holdings has announced that it has received HCPCS approval from the Pricing, Data Analysis and Coding (PDAC) contractor for its DeltaWave nasal pillow system. This approval allows durable medical equipment (DME) providers to bill Medicare and private insurance payers for all configurations of the DeltaWave system. “This marks a critical milestone for our DME partners who now have everything they need, the...
In brief: Medicare’s improper payments, DeltaWave’s expanded clearance & SleepRes’ new exec
January 21, 2026HME News Staff
WASHINGTON – The Medicare Fee-for-Service (FFS) estimated improper payment rate was 6.55%, or $28.83 billion, compared to the FY 2024 reported rate of 7.66%, or $31.70 billion, according to a new fact sheet from the Centers for Medicare & Medicaid Services (CMS).
The FY 2025 estimate marks the ninth consecutive year this rate has been below the 10% threshold for compliance established by improper payment statutory requirements, the agency says.
The...
REMSleep’s DeltaWave cleared for broadened indicated use
January 19, 2026HME News Staff
BLACKSHEAR, Ga. - REMSleep Holdings, developer of the DeltaWave nasal pillow system, has received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The approval, granted Jan. 15, 2026, significantly broadens DeltaWave’s indicated use beyond home-based CPAP therapy to include institutional settings and a wider range of patient populations.
“Our customers told us they were seeing patients who needed what DeltaWave offers...
RemSleep crosses milestone
September 5, 2023HME News Staff
TAMPA, Fla. – RemSleep has successfully passed testing protocol for 510K clearance of its DeltaWave CPAP mask, including cytotoxity and MLA tests, which were the subject of past issues requiring retesting. The company now expects submit for 510k clearance with the U.S. Food and Drug Administration before the end of September. "This is a substantial and critical milestone for RemSleep and the DeltaWave mask,” said CEO Tom Wood. “It has taken significantly longer to get to this point...
RemSleep applications advances
May 10, 2022HME News Staff
TAMPA, Fla. – RemSleep Holdings says it has responded to the Additional Information request related to its 510(k) application to the U.S. Food and Drug Administration for its patented DeltaWave nasal mask CPAP interface. “This submission is expected to be the final step and pivotal moment for our company,” said CEO Tom Wood. “It will dramatically strengthen the commercialization of our brand and make the DeltaWave a premier product that reinforces our commitment to providing...
REMSleep provides update on DeltaWave
March 29, 2022HME News Staff
TAMPA, Fla. – REMSleep has engaged a new third-party lab to redo testing for its DeltaWave as part of the 510k process for the nasal CPAP interface. The company says it has received a negative result on a cytotoxicity test due to incorrect procedures performed by a previous lab and has failed a re-test due to a faulty analysis by a testing company. “The failed test is not a result of management; we have run into a problem that we had not anticipated,” said CEO Tom Wood. “While...