Tag: CPAP Mask

AUCKLAND, New Zealand – Fisher & Paykel Healthcare expects operating revenue for the first half of the 2024 financial year, which ends Sept. 30, 2023, to be about $790 million, a 14% increase compared to the same period the previous year.  The company expects net profit after tax to be between $95 million and $105 million.   “For the first four months of the 2024 financial year, revenue from OSA masks was stronger, and revenue from hospital hardware was marginally...

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...

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...

AUCKLAND, New Zealand – Fisher & Paykel Healthcare’s mask revenue was up 28%, or 24% in constant currency, in the second half of the company’s 2023 fiscal year compared to the same period last year, thanks to a boost from its well-received Evora Full mask.  F&P launched Evora in May 2022 in the United States.  “It’s been a significant contributor to mask revenue,” said Lewis Gradon, CEO, during a call to discuss the company’s latest financial...

YARMOUTH, Maine – Oronasal masks are associated with a more collapsible airway than nasal masks, which likely contributes to the need for a higher therapeutic pressure, according to a new study published in the journal Chest. CPAP therapy delivered via an oronasal mask is associated with lower adherence, higher residual AHI and increased pressure compared to nasal masks; however, the mechanisms underlying the increased pressure requirements are not well understood. Researchers found oronasal...

PITTSBURGH – Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body.   The magnetic headgear clips are used to attach the headgear straps to the masks, a commonly used method in sleep therapy devices.  This...

AUCKLAND, New Zealand – Fisher & Paykel Healthcare has launched its Evora Full, a compact full-face mask for obstructive sleep apnea, in the United States. The mask has received FDA 510(k) clearance, paying the way for its sale in the U.S. in early May, following launches in Australia, New Zealand, Europe and Canada. “We welcome this clearance from the FDA and look forward to offering this unique full-face mask to our customers and patients,” said Justin Callahan, president-North...

AUCKLAND, New Zealand – Fisher & Paykel expects full year operating revenue of $1.675 billion to $1.70 billion for its 2022 financial year, which ends March 31.   “Our second half hospital consumables revenue is currently tracking to be similar to the hospital consumables revenue that we reported in the first half of the 2022 financial year,” said Lewis Gradon, managing director and CEO. “This is consistent with reports of the increasing prevalence of the Omicron variant...

MADISON, Wis. – Bleep has been awarded a $1.7 million SBIR grant from the National Institutes of Health to optimize positive airway pressure mask design for use in the home and acute care/hospital settings. The company will use the grant to optimize its Eclipse PAP, which focuses on having no headgear or straps and addressing leaks, and produce the validation data necessary for successful market commercialization. “Eclipse, our generation two product, will not only continue to address...

COLUMBIA, Tenn. - Baxter Management has bought SleepGlad, a cloud-based CPAP mask fitting and initial CPAP management platform for HME providers. The technology, which only requires patients to take a “selfie,” is manufacturer neutral, meaning providers can customize and add preferences from ResMed, Philips Respironics, Fisher & Paykel Healthcare or 3B Medical. “We are excited to have SleepGlad join our family of companies,” said David Baxter, owner. “We look forward...