Daily Archive: April 19, 2024

Philips halts sales of sleep apnea machines over safety concerns

Update: This story has been updated with a statement from Phillips

Medical device maker Phillips formally entered into a consent decree that stops the company from selling sleep apnea machines in the United States over health concerns that include cancer.

The decree − entered in federal court in Pennsylvania on Tuesday − requires the company to hire an independent safety firm, undergo facility testing for five years and face a review of the testing of machines sent to replace recalled machines.

The company must offer a payment option as a part of a remediation plan, a first for a device recalled under a consent decree, according to U.S. Food and Drug Administration officials.

Phillips could be fined up to $20 million annually if they fail to uphold any part of the decree.

Under an settlement agreement with the FDA and Justice Department, Philips will not be able to sell its breathing devices and ventilators used to treat sleep apnea until it meets a number of safety regulations.

Where does Phillips go from here?

The company, which did not admit wrongdoing, first revealed that it had agreed to a consent decree in a January earnings update.

“Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement announcing the decree’s entry. “Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved.”

The company is allowed to manufacture and distribute machines and parts that the FDA determine are “medically necessary.”

“Philips Respironics will continue to prioritize completing the remediation of the sleep and respiratory care devices under Respironics’ voluntary June 2021 recall,” Phillips said in a statement. “Millions of patients are currently using Philips Respironics sleep and respiratory care devices. Philips

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Hudson’s site construction hits milestone with final beam installed, name announced

DETROIT (FOX 2)A major milestone was reached on the Detroit skyline as the final beam was lifted into place at the famed Hudson site.

Standing 681 feet tall, the construction project is Detroit’s largest in half a century and years in the making.

Bedrock, the development firm behind the Hudson site’s build-out, announced the “tipping off” moment on Thursday as work begins on the next phase of construction. That includes installing the glass facade, which will continue into the spring.

To celebrate the occasion, Bedrock also announced the building’s name: Hudson’s Detroit. It was announced on social media a day after the construction milestone was announced.

“The legacy lives on. Defined by Detroit, Built for the World. The name Hudson’s has graced this site since 1891 and we’re not planning on changing it now. Introducing, Hudson’s Detroit,” the company wrote.

Once complete, the Woodward Avenue-located building will offer 1.5 million square feet in retail, office, dining, hospitality, residential, and venue space.

As the second-biggest building in Detroit once it’s completed, Barton Marlow employees said they had always wanted to work on something as big as what the Hudson’s Detroit became.

“To say I was a part of it, and to see it when I am old and retired, it’ll put a smile on my face,” said Matt Menchaca, who worked as the lead tower crane operator. He was there from the beginning of construction.

The run-up to beginning work on the tower included debate over the size of the tax break that Bedrock should get for construction.

The city council approved $60 million in relief. The building was expected to cost $1.4 billion to build.

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Official election results: Fraser’s Downtown Development Authority passes by 1 vote

The area highlighted in yellow on the map are the boundaries of the downtown development authority district now that it was approved by Fraser voters.
Town of Fraser/Courtesy image

Fraser’s ballot issues A and B, which were related to the formation of a Fraser Downtown Development Authority, both passed according to the official election results released April 11 by the town. The unofficial results released April 3 had Question A failing by four votes and Question B tied. Official results may include ballots from citizens and military personnel living abroad known as UOCAVA ballots and returned discrepancy ballots.

The results for trustees and mayor did not change.

Ballot issue A passed by one vote with 43 votes in favor and 42 against. Ballot issue A asked voters to approve an authorization of a total debt amount of up to $25 million over the 30 year lifetime of the downtown development authority.

Ballot issue B passed with 45 votes in favor and 40 against. This ballot issue allows for the formation of a Fraser Downtown Development Authority, which is often referred to as a DDA, to implement a plan of development within the specified area.

What is a downtown development authority?

DDAs are quasi-governmental entities whose primary objective is to create a development plan for the central business district and facilitate the economic development of properties within the district boundaries. They plan and develop public facilities, like streets, sidewalks and parking garages in the district.

At least five, but no more than 11 members serve on the authority. The Fraser Board of Trustees appoints members to serve on the DDA. One member must also be a member of the board. Employees of the town cannot serve on the DDA.

How’s it funded?

Ballot issue A provided a debt authorization for the

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Marketing agency sold as Thoughtmix founder takes over

Peter Watson and Bradley McKenny, former directors of Distract, have sold the Lincoln digital marketing agency to Steve Bryant, founder and managing director of Umbrella Brands Group – the company behind affiliate marketing agency Thoughtmix.

Bryant established Thoughtmix in 2015 and has worked with brands such as cardfactory, National Express and The Couture Club.

He will become the new managing director of Distract, which will transform into a specialist paid media agency.

Bryant will work with Stephanie Henderson, commercial and strategy lead, and Hannah Langton, the delivery lead, to implement a new business strategy and tactics.

Bryant is looking to focus Distract’s services on the B2C E-commerce, B2B and Education sectors.

Bryant said: “I’m excited to lead Distract into its next phase of growth and development. The team deliver some exceptional results for its Clients, and I’m delighted to have been welcomed in to harness their skills and expertise.”

Henderson added: “It’s a really exciting time for Distract. Steve brings a host of knowledge from his experience growing Thoughtmix to one of the largest agencies within the affiliate space. The offerings from both separate agencies complement each other really well and offer the potential for some really unique collaborations.”

Langton said: “Steve’s approach to Distract and the direction he has presented have been very refreshing and give us a clear plan for the future. His experience in affiliate marketing has given the team a new perspective, and we’re all looking forward to the changes being made and the relationship with Steve and Thoughtmix.”

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