FDA will review fewer COVID-19 test EUA submissions

The FDA has granted emergency use authorization for more than 430 COVID-19 tests. [Photo courtesy of Mayo Clinic]

The FDA is pushing COVID-19 test developers away from emergency use authorization (EUA) submissions in favor of more traditional pathways, the agency said today.

The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review pathways.

The policy update comes a week after the U.S. Department of Health and Human Services Office of Inspector General released a study that found the FDA’s EUA process authorized problematic tests and frustrated diagnostics developers.

The FDA’s “calculated decisions to increase availability of COVID-19 testing … often came at a potential cost to test quality,” the report said. R…

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N95 respirators removed from FDA medical device shortage list

An N95 mask made by Moldex. (Image courtesy of Moldex)

The FDA today removed N95 respirators from its medical device shortage list.

The agency credited increased domestic manufacturing of the face masks, new supply chain data from the industry and federal government, and approval from the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) of new disposable N95s and reusable respirators.

The FDA did not announce any new additions to the device shortage list, but added two brands of needles and syringes (product code GAA) and two brands of viral transport media (product codes QMC and JSM) to its device discontinuance list.

The FDA last month identified new shortages of automated external defibrillators (AEDs), chest drains/suction canisters and autotransfusion systems.

Respirators were one of the first medical devices identified in c…

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Startup licenses Harvard tech to develop ultra-sensitive COVID antibody assay

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

New startup Spear Bio plans to commercialize ultrasensitive protein-detection technology from Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Boston-based Spear Bio licensed the DNA nanotechnology-driven Successive Proximity Extension Amplification Reaction (SPEAR) in a worldwide exclusive agreement with Harvard’s Office of Technology Development.

Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in small-volume samples with an initial focus on research-use-only applications, Harvard said in a news release.

RELATED: Here’s where Harvard’s engineering dean sees medtech research going Read more

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Senators seek post-market FDA study of pulse oximeters and skin color

Pulse oximeters have been shown to be less reliable when used on patients with darker skin. (Image from the American Lung Association)

Democratic U.S. senators are prodding the FDA to launch a post-market study of pulse oximeters due to unreliable performance for patients with dark skin.

Pulse oximeters estimate blood oxygen levels (SpO2) and pulse rates in patients using infrared light — usually on a fingertip — at home or in clinical settings. Blood oxygenation is one of the leading vital signs for monitoring and treating COVID patients, but the devices have shown less accuracy for non-white patients than white patients.

RELATED: UCLA prof says racial bias in medical devices like pulse oximeters is based in physics

Citing a need to understand technical improvements that would make the devices more reliable, the lawmakers — Sens. Cory Booker (D-New Jersey), Tammy Duckworth (D-Illinois), Edwar…

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FDA issues new COVID-19 testing guidance to avoid false negatives

New at-home COVID-19 antigen testing guidance recommends repeat testing after a negative result. [Image courtesy of Abbott]

COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers.

The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies from people likely infected by the omicron variant shows repeat testing increases the chance of an accurate result, reducing the likelihood of spreading the virus.

“At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19,” the FDA said yesterday. “At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polym…

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What Fresenius learned about COVID, kidneys and dialysis in the pandemic

Dr. Robert Kossmann is the chief medical officer for Fresenius Medical Care North America [Photo courtesy of Fresenius]

Dr. Robert Kossmann has a unique perspective of kidney care as the chief medical officer for Fresenius Medical Care North America and head of renal therapies for the company’s global medical office.

Germany-based Fresenius is the world’s largest provider of dialysis equipment and dialysis services, offering treatments at traditional dialysis centers as well as in patients’ homes.

Medical Design & Outsourcing recently spoke with Kossmann about kidney care in the pandemic, the challenges and benefits of home dialysis, logistics lessons learned and growth opportunities that medtech designers and engineers should keep in mind.

This conversation has been lightly edited for space and clarity.

MDO: What does COVID do to the kidneys during and after an infect…

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Long COVID study finds potential in hyperbaric oxygen therapy

These before-and-after brain scans show improved blood flow in long COVID patients after hyperbaric oxygen therapy. [Image courtesy of Aviv Clinics]

A clinical trial involving 73 patients with long COVID has shown positive results from hyperbaric oxygen therapy (HBOT), Aviv Clinics said today.

The prospective, randomized, double-blind, placebo-controlled clinical trial was published in Scientific Reports and conducted by Israel’s Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center and Tel Aviv University.

“Millions of those who have recovered from COVID-19 are experiencing debilitating symptoms which persist for weeks, months or even years following their original infection,” Dr. Amir Hadanny, chief researcher and head of global clinical operations at Aviv Clinics, said in a news release. “Until today, no effective therapy has been suggested. Our research is the f…

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Dexcom focuses on early diabetes diagnosis as COVID links emerge

Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.

In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.

Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.

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

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Dexcom focuses on early diabetes diagnosis as COVID links emerge

Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]

New data is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.

In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.

Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.

The following has been lightly edited for space and clarity.

MDO: How does the SARS-CoV-2 virus and its COVID-19 disease affect the pancreas?

Walker: In February, March of 2020, there were a couple of papers published out of China very early in the expe…

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How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.

The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.

The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.

SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22 COVID-19 patients with multiple organ failure in ICUs. The treatment reduced mortality to 50% (compared to 81% in the control group), while patients who used the device for more than 96 hours saw…

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How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]

SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.

The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.

The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.

SeaStar Medical CEO Eric Schlorff [Photo courtesy of SeaStar Medical]

SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22…
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Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

Dr. Philip Adamson is chief medical officer of Abbott’s heart failure business [Photo courtesy of Abbott]Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body.

What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, even in mild cases. This once-in-a-century pandemic that has already killed millions across the globe could leave hundreds of millions more with chronic conditions varying in acuity.

“Not only is the viral infection bad for some people, but the subsequent body’s reaction to the viral illness in many people is remarkable. I personally have never seen anything like it,” said Dr. Philip Adamson, chief medical officer of Abbott’s heart failure business. “I’ve lived through and trained through the AIDS epidemic and learned a lot abo…

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