Tag: CPAP Device

NASHVILLE, Tenn. - SleepRes, developer of the V̇-Com, has announced Bernard Hete, PhD, as its chief technology officer to oversee future research and development. He was a senior engineer at Philips Respironics for 30 years. “Bernie [Dr. Hete] was always the smartest guy in the room, who always kept our ideas at Respironics to the laws of physics,” said Eugene Scarberry, a retired senior engineer at Philips who got the first FDA approval for CPAP back in 1985. “I have known Bernie...

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...

SAN DIEGO – About 52% of Americans reported snoring or being told they snore, but only 33% are concerned about the associated health implications, according to ResMed’s 2022 Global Sleep Surveys.  “Sleep quality can be impacted by lifestyle changes and poor habits, but many people are struggling with undiagnosed conditions that may be the root cause,” said Carlos M. Nunez, M.D., ResMed’s chief medical officer. “Sleep apnea is a serious health concern, but...

AMSTERDAM, the Netherlands – Philips does not anticipate a delay to its recall or replacement program as a result of a recent report from the U.S. Food and Drug Administration, the company told its provider customers in a Nov. 23 letter.  The FDA recently published the results of its inspection of Philips’ manufacturing facility, noting the silicone-based foam used in a singular, similar CPAP/BiPAP device marketed outside of the U.S. failed one safety test for the release of volatile...

BIRMINGHAM, Ala. – Provider Woody O’Neal did his homework when it came to opening CPAP Plus – a division of O’Neal Medical that focuses on sleep therapy and portable oxygen concentrators – which has helped to put the new company in a good position, despite the Philips recall.  CPAP Plus is located in an area of Birmingham where one-third of O’Neal Medical’s existing customers reside, a local hospital has announced expansion plans and seven sleep centers...

WASHINGTON – Industry stakeholders are pushing back on a CMS alert that, they say, makes it seem like patients can get CPAP devices and ventilators affected by a recent Philips recall replaced or repaired right away.  The alert states: “If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than five years old. If the equipment is more...

YARMOUTH, Maine – CGS has updated its FAQ on the Philips recall, adding two new questions and revising three questions. The two new questions are: If a beneficiary with a patient-owned recalled device refuses warranty support or chooses to purchase a replacement device out of pocket, will the DME MACs honor an executed ABN that holds the beneficiary responsible for replacement (outside of warranty) as same or similar to equipment previously purchased be Medicare? The DME MACs will...

CAMBRIDGE, Mass. – Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of the company’s sleep and respiratory care devices.  “The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone, and certain environmental conditions involving high humidity and temperature,” the company stated...

SAN DIEGO – ResMed is positioning a new online shop as a way for the manufacturer to be a “strong partner” for its HME provider customers.  The company last week launched shop.ResMed.com to sell its AirMini travel CPAP devices to cash-paying customers.  “By setting a benchmark for the online patient experience, we’re maximizing patients’ awareness of and demand for the products and services HMEs provide,”...

YARMOUTH, Maine - Two of the largest manufacturers of CPAP devices say using ozone to clean and sanitize their products may affect warranties. Philips Respironics In a letter responding to a customer's request for written guidance, Philips Respironics said using SoClean on its DreamStation will not automatically void the warranty, but the company “reserves the right to void a warranty if it is determined that the use of SoClean caused a defect for which a device otherwise under warranty...