Tag: RemSleep
REMSleep patent approved
September 5, 2024HME News Staff
CLEARWATER, Fla. - REMSleep Holdings has announced that another utility patent for its Nasal Ventilation System has been allowed by the U.S. Patent and Trademark Office. The company expects to receive the patent approximately eight weeks after it files the necessary paperwork. REMSleep is now waiting for the delivery of silicone raw materials, expected during the first week of October, to produce inventory for market launch. Immediately after the launch of the Deltawave, REMSleep intends to submit...
In brief: NCART appeals, REMSleep clears, AOPA awards
July 19, 2024HME News Staff
WASHINGTON – NCART has submitted a HCPCS coding application to formally appeal CMS’s decision to only increase the fee schedule for seat elevation systems by about $13 to $2,013.96. “While we appreciate CMS’s willingness to listen to our concerns and review the follow-up information we provided, they indicated it could not be considered, since it was not part of the public meeting process last year,” said Wayne Grau, executive director of NCART. “In addition, we...
REMSleep receives clearance, details marketing plan
July 18, 2024HME News Staff
CLEARWATER, Fla. – REMSleep Holdings has been awarded 510(K) clearance from the U.S. Food and Drug Administration for its new Deltawave CPAP Pillows Interface mask. With the clearance, the company has begun preparing the Deltawave for market by updating its website and ordering a large inventory. REMSleep has also announced a strategic marketing plan for Deltawave that includes identifying key distributors, providing comprehensive training to those distributors, expanding its reach, and...
In brief: RemSleep milestone, Medtrade ‘surge’
September 6, 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 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 receives OTCQB status
July 13, 2022HME News Staff
TAMPA, Fla. – RemSleep Holdings has received approval to be uplisted to OTCQB status with otcmarkets.com. “This is a great milestone for RemSleep and our shareholders,” said Tom Wood, CEO. “We could not be more excited for where we are currently positioned and the trajectory of where we are going. Uplisting to OTCQB status provides next level accountability from us as a company with higher reporting standards and more comprehensive compliance requirements.” RemSleep...
RemSleep seeks OTCQB status
June 14, 2022HME News Staff
TAMPA, Fla. – RemSleep has officially filed its application for OTCQB status with otcmarkets.com and expects to receive a decision in about three to four weeks. The company believes the move to the OTCQB will provide enhanced investor benefits, including higher reporting standards, greater access to analyst coverage and news outlets, and more comprehensive compliance requirements. The U.S. Securities and Exchange Commission considers the OTCQB an “established public market” for...
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...
RemSleep engages investor relations firm, news service
January 25, 2022HME News Staff
TAMPA, Fla. – RemSleep Holdings has partnered with Preya Co. and MCAP Mediawire to maximize its communication and exposure with current and potential shareholders, as well as refine and broaden its overall messaging and outreach. The move comes as the company prepares to get its DeltaWave nasal CPAP interface approved by the U.S. Food and Drug Administration and launched to market. “We feel we owe it to our current and future investors to have partnered with a gold star firm to assist...