covid-19 Archives - Page 4 of 113 - Medical Design Sourcing

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…

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…

COVID-19 immunity test developers at MIT seek diagnostic manufacturer

A COVID-19 immunity detection test developed by MIT could help people determine their risk of infection. [Image courtesy of MIT]

MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA.

The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample, the researchers said in a study published in Cell Reports Methods.

The researchers have filed for a patent on the technology, which could help people weigh their COVID-19 immunity against risk and determine necessary precautions such as boosters.

RELATED: Harvard researchers plan to sell at-home, PCR-grade COVID testing system

The development comes more than two years into the pandemic as the latest virus mutation…

Moderna inks deal with US for up to 300M omicron boosters

The U.S. government will pay $1.74 billion to buy 66 million doses of Moderna’s COVID-19 vaccine made with the new omicron-adapted formula, the drugmaker said today.

The government has the option to acquire up to 300 million total doses of the omicron boosters under the agreement.

The U.S. last month agreed to buy 105 million doses of Pfizer and BioNTech’s updated vaccine for $3.2 billion. That deal similarly includes an option for up to 300 million doses.

Moderna is developing the bivalent vaccine candidate mRNA-1273.222 based on feedback from the FDA. The vaccine incorporates mRNA from the omicron BA.4/5 strain.

“Moderna’s mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets omicron subvariants BA.4 and BA.5, the most prevalent variants of concern in the U.S. today,” Moderna CEO Stéphane Bancel said in a news release.

Scientists are uncertain whether BA.4/BA.5–based v…

FDA re-authorizes Meridian Bioscience’s COVID-19 assay

Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test.

Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to delay marketing so it could modify the design to correctly detect the variant.

According to a news release, Meridian completed the development work and submitted an initial data set to the FDA to validate the performance of the redesigned assay in March, then completed additional clinical studies in order to garner re-authorization.

The company intends to begin shipping the product by the end of its fiscal fourth quarter on Sept. 30, 2022.

“There continues to be demand for fast, accurate detection of COVID-19 especially considering the high transmissibility of these …

Fall 2022 COVID-19 vaccine candidate tracker

[Photo from Pexels]

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines.

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

Customizing textiles to design formfitting face masks

Image courtesy of MIT and Lavendar Tessmer

Researchers at the Massachusetts Institute of Technology have developed an active fiber and process that uses heat to activate face masks and conform to an individual’s face.

The COVID-19 pandemic has emphasized the importance of face masks that effectively seal around the nose and mouth. However, faces and their features vary and make standard one-size-fits-all face masks less effective.

Lavender Tessmer, who is a doctoral candidate in MIT’s Department of Architecture, created an active fiber and process that uses heat with specific knit textile architecture to activate a mask to conform to specific faces. It uses standard textile equipment and a new customization process that allows any manufacturer to create a customized mask.

Prior to the pandemic, Tessmer was working with associate professor Skylar Tibbits in the department of archite…

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…

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…

Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old.

As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.

On June 17, FDA authorized the use of the Pfizer-BioNTech and Moderna vaccines in children as young as six months in the U.S. Before that, an FDA advisory committee unanimously supported the authorization of the Pfizer and Moderna vaccines in young children.

The EMA request included data from a Phase 2/3 randomized, controlled study based on data from 4,526 children 6 months to less than 5 years of age.

The study found that three doses of the vaccine resulted in a robust immune response with a safety profile similar to a placebo. In addition, the companies noted that adverse events were less common in young c…

CureVac files lawsuit against BioNTech over patent infringement

The mRNA-focused biopharma CureVac N.V. (Nasdaq:CVAC) has filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech SE (Nasdaq:BNTX) demanding compensation for infringement of CureVac’s patents.

In particular, the lawsuit claims that the four German patents, EP 1 857 122 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974 U1, were used in the manufacture of the Comirnaty COVID-19 vaccine from BioNTech and Pfizer (NYSE:PFE).

Investors reacted by sending CVAC shares down 1.05% to $14.09. Meanwhile, BNTX shares were up 2.24% to $161.03.

CureVac is not aiming to block the production or distribution of the COVID-19 vaccine.

Over the past year, CureVac has seen its stock valuation plummet after failing to commercialize its first-generation mRNA COVID-19 vaccine.

In June 2021, the company announced that the interim efficacy of the vaccine candidate was 47% in a Phase 2b/3 study.

CureVac is currently par…

Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says

The Masimo SafetyNet [Image from Masimo]Masimo (Nasdaq:MASI) announced that a two-part retrospective study demonstrated the impact of its SafetyNet monitoring system.

Irvine, California-based Masimo’s study, led by Dr. Hemali Patel and colleagues at the University of Colorado and UC Health (UCH) in Aurora, Colorado, evaluated the impact of remote patient monitoring of COVID-19 patients using SafetyNet on hospital length of stay. Results were published in Telemedicine and e-Health.

SafetyNet uses tetherless Masimo Radius PPG SET pulse oximetry and a smartphone app to transmit continuous, home-based patient monitoring data to hospital clinicians. According to a news release, the study demonstrated a significant association between briefer hospitalization and patients discharged with SafetyNet and without home oxygen.

The researchers concluded that “home telemonitoring after discharge for patients with COVID-19 may be a safe tool that may reduce th…