Quote:Amid ongoing scrutiny and regulatory challenges since its June 2021 recall of certain CPAPs, BiPAPs, and ventilators, Philips Respironics is discontinuing the sale of sleep diagnostic and certain respiratory care products, including the Alice NightOne home sleep test and DreamStation Go CPAP, in the United States and US territories.

According to a portfolio update on its website,

“Philips Respironics will focus on the sale of consumables and accessories, including masks, and
will not return to the sale of hospital ventilation products, certain home ventilation products,
portable and stationary oxygen concentrators and sleep diagnostic products.”

“We have streamlined our portfolio to enable us to focus on programs that are best suited to changing market dynamics and will most effectively serve patients and customers in the future. We will be here to support customers and patients through the end of service for these products as well as products that will continue to be actively sold. Customers will be contacted directly regarding any order cancellations resulting from our portfolio changes.”

According to the notice, changes to Philips’ commercial portfolio will not affect the company’s “commitment to the remediation of devices impacted by the June 2021 recall of certain CPAP, BiPAP and mechanical ventilator devices.”

Quote:Mr. McGinnis was widely revered as the progenitor of the first mass-produced breathing machine in the United States — a device that has treated millions around the world who suffer from sleep apnea, a chronic and potentially deadly condition in which breathing starts and stops intermittently during the night.

Quote:"Philips recall crisis casts a shadow over legacy of Respironics founder"
CPAP inventor Gerald McGinnis says the recall is a 'disappointment and embarrassment'
Pittsburgh Post-Gazette  |  December 30, 2023

In an extensive interview — his first in the aftermath of the recall — the 89-year-old engineer described his profound disappointment in what happened to the brand that he created as well as concerns about company practices that risked the safety of millions. “If you hurt somebody, the game is over,” he said. “You’ve got to take responsibility.”

Quote:In 1976, company (Respironics) founder Gerald McGinnis opened the company's first manufacturing facility for anesthesia masks near Pittsburgh, Pennsylvania. The company introduced the first continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea in 1985. In 1992, Respironics received a patent for bi-level technology. This technology was originally intended as an improvement on CPAP, however, its use has expanded into the treatment of other breathing disorders such as chronic obstructive pulmonary disease (COPD).

• The CPAP machine was first invented by Colin Sullivan (Australia) in 1980, 5 years before the start of Respironics' production of CPAP machines in the U.S. Dr. Sullivan first conceived of the concept while working with another physician while at the University of Toronto (Canada). Upon returning to Australia, Dr. Sullivan implemented his technology concept and began his initial application of his CPAP concept. https://en.wikipedia.org/wiki/Colin_Sullivan_(physician)
  
  
• One might say that Respironics founder Gerald McGinnis was to CPAP what Henry Ford was to the mass production of the automobile. Although Gerald McGinnis was not the initial inventor of the first CPAP machine, Mr. McGinnis and Respironics (est. 1976) was also an inventor of additional respiratory products and technologies, some of which predate the invention of the CPAP machine in Australia.
  
  
• In 2007, Respironics announced it entered into a merger agreement with Philips for $5.1 billion.
  

(01-29-2024, 09:37 AM)btreger Wrote: "Philips will not sell new devices to treat sleep apnea in the U.S. in the coming years"

[CNBC]  “We believe it will be very difficult for Philips to recover its U.S. Respironics market position.”

(01-29-2024, 02:35 PM)btreger Wrote: [Fierce Biotech] "Outside of the U.S., meanwhile, where sales of CPAP and BiPAP machines have recently restarted in the wake of the 2021 recall, the company will be able to continue selling its respiratory devices"

(01-29-2024, 02:46 PM)WakeUpTime Wrote: I'll be very surprised if the Health Agencies in many western countries (U.K., Australia, Canada, France, etc.) don't follow the U.S. FDA's actions.  If I were in another country and learned that the U.S. FDA requested a halt of production for year(s) based on potential quality issues that could impact patients' health, I'd react very quickly or face significant criticism, ridicule, or liability down the road for not acting in a similar way.  It's also much cheaper for them to do that than to conduct their own country's internal investigation into the quality of currently manufactured DreamStations.  I'll be very surprised if this event becomes exclusive to the U.S.

(01-29-2024, 03:10 PM)SuperSleeper Wrote: So, basically NO MORE Phillips CPAP machines are going to be sold for the foreseeable future.

But, yeah... this is a "WOW" moment for the CPAP market.