Dept. of Health & Human Services (HHS) Archives - Page 2 of 4

Biden administration orders home COVID-19 tests

The U.S. Defense Dept. announced today that it awarded Ellume $231.8 to onshore production capacity of its Ellume COVID-19 home test.

In coordination with the U.S. Dept. of Health and Human Services (HHS), the DoD contract is an industrial base expansion to allow Ellume to increase the production capacity of its home test by 640,000 tests per day by December 2021.

The expansion includes the procurement of 8.5 million tests to be distributed across the U.S. in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness policy established January 21, 2021, according to a news release.

Valencia, Calif.-based Ellume’s COVID-19 home test is the first FDA-authorized fully at-home diagnostic for detecting symptomatic or asymptomatic COVID-19, having received emergency use authorization (EUA) in December. The test’s development was supported by the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnos…

HHS could make permanent pandemic-related exemptions for some devices

HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.

In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.

Get the full story on our sister site, Medical Design & Outsourcing.

HHS seals plan to sunset regulations 10 years or older

(Image by Michael Longmire on Unsplash)

The U.S. Department of Health and Human Services (HHS) today issued a final rule giving it five years to review and potentially sunset regulations that have been in place for at least 10 years.

With some exceptions, the agency will look into whether regulations cause financial harm to a substantial number of small entities. It will also do a more detailed review to determine whether the regulation is still needed, is too complex, has drawn complaints, duplicates or conflicts with other rules, and whether technological, economic and legal changes have passed it by.

Get the full story on our sister site, Medical Design & Outsourcing.

MedTech 100 roundup: Stocks top pre-pandemic high

After weeks of flirting with the heights hit before COVID-19 ravaged the markets, medtech stocks finally topped the pre-pandemic high last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — spiked up to 93.11 points on Sep. 2, nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.

Medtech stocks had hit a previous mid-pandemic high of 91 points last week, hanging around there before the sudden rise to 93.11, which was followed by a quick dip to 90.64 points 24 hours later.

The index dipped from that peak, though, sitting at 89.29 points at the end of last week (Sep. 4). Overall, medtech stocks saw a -1.6% decrease from the 90.78-point total at the same time a week prior (Aug. 28).

The most recent high mark represents a 0.9% rise from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -3.3% decrease from that pre-pande…

Report: Feds to send Abbott’s rapid tests to states for school reopenings

Abbott’s BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]

The U.S. government is reportedly set to use rapid COVID-19 tests it purchased from Abbott (NYSE:ABT) for school reopenings.

Reuters reported that the feds will send an “overwhelming majority” of Abbott’s tests to governors and state territories to support school reopenings and other critical tasks, according to a Trump administration official. The administration struck a $750 million deal with Abbott for 150 million of its tests last week.

A day before the deal was announced, Abbott received FDA emergency use authorization (EUA) for its BinaxNow COVID-19 Ag Card — a speedy antigen test for the virus that can be directly read off the testing card. The test is designed to display a result 15 minutes following a nasal swab: one line for a negative result and two for a positive result.

The test will be accompanied by…

Report: U.S. ventilator stockpile is full

Philips Trilogy EVO portable ventilator (Image courtesy of Philips)

The U.S. Dept. of Health and Human Services (HHS) is reportedly terminating more ventilator contracts as the national stockpile is full.

The Hill reported today that HHS is throwing out some of the contracts that totaled $3 billion as the U.S. government sought to supply as many ventilators as possible during the first surge of the COVID-19 pandemic.

This news follows a recent announcement from Royal Philips (NYSE:PHG) that it would not be supplying the remaining 30,700 ventilators it was slated to manufacture by December to the Strategic National Stockpile, with HHS canceling the contract after the Amsterdam-based company delivered 12,300 total bundled ventilator configurations supplied to the stockpile through August, falling in line with the stipulations of the contract.

HHS has not divulged details on any terms of their can…

Ventec, GM complete HHS ventilator contract

(Image courtesy of Ventec)

Ventec Life Systems and General Motors announced today that they completed their government contract to produce 30,000 ventilators.

The two companies kicked off mass production of Ventec’s V+Pro critical care ventilator at GM’s Kokomo, Ind., plant in April, having received a $489.4 million contract from the U.S. Dept. of Health and Human Services to deliver 30,000 ventilators by the end of August amid the COVID-19 pandemic.

Following yesterday’s shipment to complete the delivery, GM has formally turned over operational control of the Kokomo manufacturing operation to Ventec, which will produce its VOCSN multi-function critical care ventilators there and in Bothell, Washington, to continue to meet demand for ventilators as the COVID-19 pandemic roars on.

Ventec’s monthly ventilator production increased by 80 times during the pandemic, the compan…

Philips ends ventilator distribution deal with HHS

Royal Philips (NYSE:PHG) announced today that the U.S. Dept. of Health and Human Servies partially terminated its ventilator manufacturing contract.

Amsterdam-based Philips received the termination notice from HHS after agreeing to a contract in April to deliver 43,000 bundled EV300 ventilator configurations to HHS through December 2020 amid the COVID-19 pandemic.

News of the contract termination follows a congressional report from July accusing the Trump administration of bungling plans to obtain ventilators early in the coronavirus pandemic, claiming that federal officials squandered more than $500 million in a contract with Philips.

The company will complete its deliveries for August, which will result in 12,300 total bundled ventilator configurations supplied to the Strategic National Stockpile, falling in line with the stipulations of the contract. The remaining 30,700 ventilators the company was contracted to manufacture will not be supplied to the…

HHS to release 1.5M N95 respirators to nursing homes

HHS will release 1.5 million N95 respirators from the Strategic National Stockpile for distribution to approximately 3,336 nursing home facilities across the United States.

The respirators, made in the U.S. by the Halyard business of Owens & Minor (NYSE:OMI), will go to select nursing homes that recently reported only enough supplies for only zero to three days of operations, according to the announcement, posted yesterday. Shipments start Aug. 28.

“President Trump and Secretary Azar remain fully committed to caring for our nation’s most vulnerable citizens, and that means ensuring nursing homes have the equipment and supplies they need to treat patients safely during the pandemic,” said Dr. Robert Kadlec, the HHS Assistant Secretary who oversees the SNS. “This additional federal supplement of N95 respirators from the SNS will immediately help those nursing homes prevent the spread of COVID-19 and keep the patients they care for safe during this pandemic.”

HHS pulls FDA back from regulating some COVID-19 tests

[Photo by Fusion Medical Animation on Unsplash]

FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website.

Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision posted Aug. 19.

The decision stated: “The Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts.”

Get the full story on our sister site Medical Design & Outsourcing.

Report: Ventilators are piling up in government stockpiles

(Image courtesy of Ventec)

As the COVID-19 pandemic roars on, the government stockpile of once-in-demand ventilators has reportedly turned into a collection of unused devices.

The Washington Post reports that, following the panic caused by an anticipated ventilator shortage and subsequent rush to add to the stockpile after President Trump invoked the Defense Production Act, the approach to treating COVID-19 changed and continued efforts to produce ventilators may come too late.

According to the report, the U.S. Dept. of Health and Human Services (HHS) said it distributed 15,057 ventilators as of last Friday, with 95,713 ventilators remaining in the stockpile, among which 94,352 had come from contracts signed since the pandemic began.

When the pandemic began, ventilators were highly sought after, but, more than five months in, The Washington Post said medical experts claim intubation for COVID-1…

Feds ink COVID-19 vaccine distro deal with McKesson

The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a COVID-19 vaccine distribution deal with McKesson.

Under Operation Warp Speed, McKesson will become a central distributor of future COVID-19 vaccines and related supplies needed to administer the pandemic vaccinations, according to a news release.

Get the full story at our sister site, Pharmaceutical Processing World.