Tag: SoClean
SoClean: There is now a way to regulate performance
September 13, 2024Liz Beaulieu, Editor
PETERBOROUGH, N.H. – SoClean’s Bob Wilkins says the company is trailblazing a new path for bacterial reduction devices for CPAP hoses and masks with its new clearance from the U.S. Food and Drug Administration.
The company announced in August that its SoClean 3+ now has de-novo clearance from the FDA for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device.
Here’s...
In brief: Mobility study, ADS-StrideMD partnership, SoClean clearance
August 21, 2024HME News Staff
PITTSBURGH – Clinical investigators from the University of Pittsburgh and the Medical University of South Carolina recently published a study that shows different types of mobility devices and certain characteristics of people with limited mobility are associated with reported falls.
The study, published in the journal Disability & Rehabilitation: Assistive Technology, and based on an analysis of more than 11,000 deidentified cases from the Functional Mobility Assessment and Uniform...
FDA grants auth to SoClean device
August 19, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has granted a marketing authorization to SoClean for its SoClean 3+ bacterial reduction device for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device. The SoClean 3+ does not replace the cleaning steps recommended by manufacturers of CPAP devices. To date, there are no FDA cleared or approved devices for cleaning, disinfecting or...
In brief: Philips sues SoClean – again, AAH re-engages lawmakers, Enos re-enters sleep market
May 17, 2024HME News Staff
PITTSBURGH – Philips has sued SoClean in a bid to get the company, whose ozone cleaners it says “attacks” the foam in its CPAP devices, to pay part of its recently announced $1.1 billion settlement.
Philips announced the settlement in April to resolve the personal injury litigation and the medical monitoring class action related to a recall of certain sleep and respiratory devices in the U.S.
“(SoClean’s) negligent and intentionally misleading...
Philips wants SoClean to pay part of settlement
May 16, 2024HME News Staff
PITTSBURGH – Philips has sued SoClean in a bid to get the company, whose ozone cleaners it says “attacks” the foam in its CPAP devices, to pay part of its recently announced $1.1 billion settlement.
Philips announced the settlement in April to resolve the personal injury litigation and the medical monitoring class action related to a recall of certain sleep and respiratory devices in the U.S.
“(SoClean’s) negligent and intentionally misleading...
Philips countersues SoClean
January 5, 2024HME News Staff
PITTSBURGH – Philips on Jan. 5 filed a counter lawsuit against SoClean and its private equity owner, DWHP, arguing they "recklessly and unlawfully” marketed their ozone cleaning devices as compatible with its CPAP and BiPAP devices.
“Contrary to SoClean’s repeated representation of compatibility, SoClean knew that its ozone cleaners had the potential to eat away at Philips Respironics’ PAPs from the inside,” the company states in the lawsuit filed...
In brief: SoClean field correction, HCD CEO, reimbursement relief efforts
November 29, 2023HME News Staff
PETERBOROUGH, N.H. – SoClean on Nov. 16 issued an urgent medical device field correction that provides clarifications to the user manuals for its SoClean2 and SoClean 3 and notifies users of the availability of a hose and mask adapter for the maintenance systems.
SoClean is revising its labeling to incorporate additional warnings and contraindications, as well as proper and consistent device setup instructions, including use of a hose and mask adapter to reduce potential risks associated...
SoClean issues field correction
November 27, 2023HME News Staff
PETERBOROUGH, N.H. – SoClean on Nov. 16 issued an urgent medical device field correction that provides clarifications to the user manuals for its SoClean2 and SoClean 3 and notifies users of the availability of a hose and mask adapter for the maintenance systems.
SoClean is revising its labeling to incorporate additional warnings and contraindications, as well as proper and consistent device setup instructions, including use of a hose and mask adapter to reduce potential risks associated...
In brief: SoClean complaint, Drive recall, Woman of the Year announcement
December 10, 2021HME News Staff
PETERBOROUGH, N.H. – SoClean has filed an amended complaint in its lawsuit against Philips that takes into account a new inspection report from the U.S. Food and Drug Administration.
The company highlighted the following points in the amended complaint:
“Philips has known for years that the company’s products created a serious risk of harm to consumers.”
“The FDA report also confirmed that Philips had been receiving customer complaints...
SoClean amends complaint
December 6, 2021HME News Staff
PETERBOROUGH, N.H. – SoClean has filed an amended complaint in its lawsuit against Philips that takes into account a new inspection report from the U.S. Food and Drug Administration.
The company highlighted the following points in the amended complaint:
“Philips has known for years that the company’s products created a serious risk of harm to consumers.”
“The FDA report also confirmed that Philips had been receiving customer complaints...