How decontamination could solve the COVID-19 mask shortage problem

With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks.

(Image courtesy of Brian McGowan on Unsplash)

A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks.

Hundreds of frontline healthcare workers have died from the virus since the pandemic struck in China in 2019, bringing the need for effective face masks into sharp relief. But despite the efforts of 3M and other companies worldwide to boost production of the most effective filtering masks — N95s — there still might not be enough.

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These researchers adapted a stroke patient device for COVID-19

Designed to detect speech and swallowing problems, the device has found a new use in tracking cough frequency to alert healthcare providers that frontline workers may need to be tested for SARS-COV-2.

(Image courtesy of Northwestern University)

Researchers in Chicago have adapted a flexible patch they developed to monitor stroke patients for swallowing trouble to help detect symptoms of COVID-19.

They’re hoping it can help physicians decide whether frontline healthcare workers have developed symptoms of the novel coronavirus so they can prevent the illness from worsening. In their “Lost on the Frontline” series, Kaiser Health News and The Guardian have reported 922 U.S. healthcare worker deaths that likely stemmed from caring for COVID-19 patients.

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FDA authorizes mobile COVID-19 test kit

The FDA has issued emergency use authorization (EUA) for a mobile COVID-19 test kit developed by handheld detection system maker DetectaChem.

Stafford, Texas-based DetectaChem develops the MobileDetect Bio BCC19 test kit is designed to test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal swabs, mid-turbinate nasal swabs and oropharyngeal swab specimens.

The test kit utilizes a reverse transcription loop-mediated isothermal nucleic acid amplification technique, according to a letter from the FDA. The sample is added directly to reaction tubes with reagent buffers without the need for separate lysis buffers or additional extraction steps.

As part of the testing kit, DetectaChem’s MobileDetect Bio subsidiary included a mobile app which runs the test and analyzes the sample within minutes, according to MobileDetect Bio’s website.

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Does plasma therapy work against COVID-19? NIH panel says data lacking

[Photo by Fusion Medical Animation on Unsplash]

More than a week after the FDA granted an emergency use authorization (EUA) for the use of convalescent plasma against COVID-19, an NIH advisory panel is saying that there is insufficient data to recommend either for or against the treatment.

The National Institutes of Health’s COVID-19 Treatment Guidelines Panel said in a statement released today: “There are currently no data from well-controlled, adequately powered, randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.”

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Does plasma therapy work against COVID-19? NIH panel says data lacking

[Photo by Fusion Medical Animation on Unsplash]

More than a week after the FDA granted an emergency use authorization (EUA) for the use of convalescent plasma against COVID-19, an NIH advisory panel is saying that there is insufficient data to recommend either for or against the treatment.

The National Institutes of Health’s COVID-19 Treatment Guidelines Panel said in a statement released today: “There are currently no data from well-controlled, adequately powered, randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.”

FDA commissioner Stephen Hahn already apologized on Twitter last week after heavy criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35% — criticism that he acknowledged was justified. The FDA has taken heat over its decisionmaking a…

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How to navigate regulations for in vitro diagnostics

Working through the regulatory requirements for IVD devices in your target markets can mean a successful launch into an industry segment poised for great growth in the coming years.

Claudia Sirch, Intertek

(Image courtesy of the National Cancer Institute)

In-vitro diagnostic (IVD) devices help detect diseases using samples from the human body, such as blood draws or mucus swabs. Examining these specimens provides essential information to identify, cure, treat or prevent illness. As populations age and pandemics such as COVID-19, SARS, and other infectious diseases sweep the globe, the IVD market is expected to grow, resulting in an increased demand for early and simplified diagnosis and rapid-test products.

IVD regulatory requirements

Global regulatory requirements for IVD products vary and often differ from requirements for other medical devices. In the U.S., Canada and Europe, requirements d…

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FDA approves Medtronic MiniMed 770G insulin pump for young children

(Image courtesy of Medtronic)

The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G  hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years.

The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for for such young children, according to the agency. The FDA approved an earlier MiniMed model, the 670G system, for people aged 7 to 13 with Type I diabetes in 2018.

MiniMed 770G System is a Bluetooth-enabled version of the 670G, with other modifications. It works by measuring glucose levels in the body every 5 minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes: a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the …

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Baxter’s dialysis filter wins De Novo nod

Baxter (NYSE:BAX) announced today that it received FDA De Novo classification for its Theranova novel dialysis membrane.

Theranova is designed to deliver expanded hemodialysis (HDx) therapy, filtering a wider range of molecules from the blood than traditional hemodialysis (HD) filters, targeting certain molecules associated with inflammation and cardiovascular disease in patients with kidney failure, according to a news release.

HDx is similar to conventional HD, but has a change of the dialyzer membrane, allowing the Theranova’s “medium cut-off” membrane to combine high permeability and selectivity for uremic toxins while retaining essential proteins and maintaining albumin levels during treatment.

Deerfield, Ill.-based Baxter conducted a randomized, controlled study of Theranova in the U.S., evaluating safety and efficacy. After observing 172 hemodialysis patients who received therapy through either a medium cut-off dialyzer (Theranov…

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CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

Get the full story on our sister site, MassDevice.

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CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

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Abbott wins EUA for COVID-19 test that runs off a card

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

FDA has announced an emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card — a speedy antigen test for the virus that can be directly read off the testing card.

The agency in the announcement yesterday evening compared the test’s design to some pregnancy tests. A healthcare provider swabs the patient’s nose and twirls the sample on a test card with a testing reagent added. After waiting 15 minutes, the card displays a result: one line for a negative result and two for a positive result.

Abbott (NYSE:ABT) stock is up nearly 9% today, trading at more than $112 per share in afternoon trading. Stocks of other major companies in the COVID-19 testing space took a big hit — including Quidel (NSDQ: QDEL), –26%; Quest Diagnostics (NYSE:DGX) –7.6%; and Hologic (NSDQ:HOLX), –6%. Abbott’s announcement could wipe out at …

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FDA clears SurGenTec synthetic bone graft

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic bone graft.

Boca Raton, Fla.-based SurGenTec said in a news release that its novel OsteoFlo NanoPutty bone graft features the world’s first and only quadphasic synthetic bone graft particles with nano-surface technology for providing an “optimal resorption profile with unrivaled handling characteristics.”

OsteoFlo requires no mixing, reconstituting or preparation prior to use and is designed to maximize flowable properties when used in minimally invasive surgery. The putty does not harden and can flow through tiny apertures and voids.

The putty comes in two packaging configurations, either a standard syringe or a pre-filled, minimally invasive cartridge that can be used with SurGenTec’s GraftGun single-use bone graft delivery system.

SurGenTec is eyeing a launch for the OsteoFlo NanoPutty in October 20…

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