Tag: Consent Decree
Philips consent decree outlined
April 8, 2024HME News Staff
PITTSBURGH – The provisions of a consent decree between Philips Respironics and the U.S. Department of Justice were outlined in an April 4 filing in federal court, including selecting and retaining an independent expert to conduct inspections at certain facilities for several years.
The expert will conduct audit inspections every six months for a period of two years and then once every year thereafter for a total of five years at four facilities in Pennsylvania and one facility in...
Philips now has ‘clarity’ to rebuild
January 31, 2024Liz Beaulieu, Editor
AMSTERDAM – With a consent decree nearly finalized and a more streamlined product portfolio, Philips believes its sleep and respiratory care business “bottomed out” at EUR 1 billion in revenues for 2023 and will "build back from there,” says CEO Roy Jakobs.
The company announced on Jan. 29 that it has agreed on the terms of a consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory...
Philips agrees to terms of consent decree
January 29, 2024HME News Staff
AMSTERDAM – Philips has agreed on the terms of a multi-year consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory care devices, providing clarity and a roadmap to demonstrate compliance and to restore the business, the company says.
In the U.S., Respironics will continue to service sleep and respiratory care devices already with health care providers and patients, and supply accessories (including patient...
Philips previews Q3 performance
October 12, 2022HME News Staff
AMSTERDAM – Philips expects to record a EUR 1.3 billion non-cash charge in the third quarter for the impairment of goodwill of its Sleep & Respiratory Care business due to revisions to the financial forecast of the business.
The company says the drivers for the revised forecast include current assumptions regarding the estimated impact of the proposed consent decree and changes to the pre-tax discount rate.
Philips announced in July that it had begun discussions with the U.S....
Philips ‘recovery subject to consent decree’
July 29, 2022Liz Beaulieu, Editor
AMSTERDAM – Philips has established a “recovery trajectory” for its sleep and respiratory care business, but discussions with the U.S. Department of Justice on a proposed consent decree to resolve identified issues could impact the company’s plans.
The company’s trajectory includes an estimated EUR 600 million in sales of Respironics sleep systems by 2025, up from an expected EUR 200 million in 2022 and more in line with the EUR 700 million in 2019, pre-recall.
“This...
Invacare reduces workforce
December 8, 2017HME News Staff
ELYRIA, Ohio - Invacare will reduce its workforce by about 110 employees to generate $8.5 million in pre-tax savings, the company announced Dec. 7.The move, which affects employees in North America, is part of a multi-year strategic plan to transforms Invacare into a more clinically focused company, says Matthew Monaghan, chairman, president and CEO.“This reduction in force, while difficult, is an essential part of the second phase of our transformation toward becoming a more sustainably profitable,...
Invacare looks to hire again
October 26, 2017HME News Staff
ELYRIA, Ohio - After a consent decree with the U.S. Food and Drug Administration forced Invacare to reduce its workforce a number of times in the past few years, the company is ready to hire again.Invacare is hosting a job fair today at its corporate headquarters, with an eye toward hiring workers skilled in computer numerical control, welding, assembly, sewing and machine operation, according to The Chronicle Telegram.Invacare's Lara Mahoney told the local newspaper that the company is looking to...
Invacare looks to stabilize in second half of 2017
August 8, 2017HME News Staff
ELYRIA, Ohio - Invacare reported $233.5 million in net sales for the second quarter of this year compared to $275 million for the same period last year, a 15.1% decrease.For the North America/HME business segment, it reported $77.7 million in net sales compared to $110.7 million, an 86.4% decrease.“As indicated previously, we expected net sales to continue to decline through the first half of 2017 before stabilizing sequentially later in the year,” said Matthew Monaghan, chairman, president...
Invacare: Ready to earn back your business
July 28, 2017Liz Beaulieu, Editor
ELYRIA, Ohio �- Invacare looks forward to re-introducing providers to a “different company” now that it has the green light to resume full operations at its corporate headquarters and Taylor Street facilities.
The U.S. Food and Drug Administration notified Invacare in a letter dated July 24 that the company has satisfied requirements under a consent decree that has limited its ability to make and sell products from the facilities for nearly five years, since December 2012.
“When...
FDA lifts Invacare's consent decree
July 25, 2017HME News Staff
ELYRIA, Ohio - Invacare has the green light to make and sell products again from its Taylor Street manufacturing facility and corporate headquarters here, the company announced July 25.
A consent decree with the U.S. Food and Drug Administration has limited Invacare's ability to make and sell products from the facilities for nearly five years, since December 2012.
“Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United...