covid-19 Archives - Page 109 of 113 - Medical Design Sourcing

Varian launches remote care software for cancer patients

Varian Medical Systems (NYSE:VAR) announced that it launched new capabilities for its Noona software for monitoring cancer patients.

Noona supports cancer care teams with patient screening, real-time symptom reporting, secure care team messaging, telephone triage automation and patient access to medical records, enabling continuous reporting and symptom monitoring for cancer patients.

Palo Alto, Calif.-based Varian also designed a new way to quickly and remotely implement the Noona software for cancer patients and care teams in a faster manner without increasing the risk of exposure to COVID-19.

Noona has already been implemented into care offered by Tennessee Oncology, with nearly 600 care team members using it, approximately 10,000 patients accessing the application and about 31,000 patients being managed through the triage automation.

“In light of COVID-19 and the difficulties it poses to the current state of cancer care delivery, cancer …

Steris wins second EUA to decontaminate up to 30m respirators per day

Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators.

The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA authorized the cycle for use on Steris’ Amsco medium-heat sterilizers, which the agency previously cleared.

The Dublin, Ireland-based company estimated that the new method could decontaminate more than 30 million respirators per day if all of its compatible U.S.-based sterilizers are fully employed.

Compatible N95 respirators will be individually pouched using sterilization pouches that are FDA-cleared for steam sterilization. They may be decontaminated by this process up to 10 times and be reusable only by the original users, according to the EUA.

This is the second EUA for Steris t…

FDA clears 4D Medical’s lung imaging technology

4DMedical announced that it received FDA clearance for its XV Technology for analyzing functional lung impairment from a single X-ray.

Australia-based 4DMedical (formerly 4DX), which has a U.S. base in Woodland Hills, Calif., designed the XV Technology as a four-dimensional lung imaging process in the form of a software-as-a-service (Saas) diagnostic tool.

The software rapidly and automatically analyzes and applies algorithms to identify and quantify any functional lung impairment, generates a ventilation report and sends it to the hospital to enable clinicians to determine the course of action for treatment. The end-to-end process can be completed with a report within three hours.

XV Technology is not intended for replacing molecular tests as a primary diagnosis method for COVID-19, but 4DMedical believes its ventilation reports can help provide quantitative support for diagnosis and follow-up examinations, according to a news release.

“Our…

Merck, IAVI work to develop COVID-19 vaccine

Merck (NYSE:MRK) and IAVI announced today that they are collaborating to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19.

The vaccine candidate is slated to use the recombinant vesicular stomatitis virus (rVSV) technology used as the basis for Merck’s Ervebo Ebola Zaire virus vaccine, which was the first such vaccine to be approved for use in humans, according to a news release. Merck also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Dept. of Health and Human Services, to provide funding for the collaboration.

Get the full story at our sister site, Drug Discovery & Development.

Merck, IAVI work to develop COVID-19 vaccine

Merck (NYSE:MRK) and IAVI announced today that they are collaborating to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19.

The vaccine candidate is slated to use the recombinant vesicular stomatitis virus (rVSV) technology used as the basis for Merck’s Ervebo Ebola Zaire virus vaccine, which was the first such vaccine to be approved for use in humans, according to a news release. Merck also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Dept. of Health and Human Services, to provide funding for the collaboration.

“COVID-19 is an enormous scientific, medical, and global health challenge,” Merck Research Laboratories president Dr. Roger Perlmutter said in the release. “Merck is collaborating with organizations around the globe to develop anti-infectives and vaccines that aim to alleviate suffering caused by SARS-CoV-2 infection.

“Merck and IAVI are…

FDA signals PPE shortage, issues EUA for more

This map by GetUsPPE shows where shortages of personal protective equipment are most acute in the U.S.

The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country.

The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories.

The FDA said it issued the EUA in response to concerns about shortages of gowns and other apparel for use by healthcare personnel. Earlier this month, the agency said that healthcare organizations had informed the agency that some distributors may be allocating PPE basing on a health system’s previous use rather than its projected use.

Shortages of PPE prompted a recent article in The Lancet, based on a study by GetUsPP…

Mass-producing a COVID-19 vaccine is going to be hard

[Photo by Fusion Medical Animation on Unsplash]

Creating a safe and effective COVID-19 vaccine is just the first step. Recent media reports suggest that making it will also be a major challenge.

There are presently a number of vaccine candidates around the world that are showing promise and entering the clinical studies phase — a speed of development usually unheard of in the vaccine space. The fact that there is more than one potential vaccine showing promise is good: Experts say the world will likely need more than one approved vaccine to effectively scale up production.

But some of the promising vaccine candidates from companies such as Inovio and Moderna use cutting edge technology that has never been scaled up to produce millions of vaccine doses in factories, according to a recent report in The New York Times.

In the U.S., the White House has created a private-public partnership called Ope…

FDA eases regs on certain device changes during pandemic

The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions.

In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create an undue risk. The new guidance will remain in effect for the duration of the COVID-19 public health emergency.

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

Abbott: ID NOW COVID-19 results more accurate with earlier testing

Abbott’s ID Now test machine (Image from Abbott)

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms.

The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization (EUA) on March 27 and said it is now investigating whether false-negative results could be due to the types of swabs used or the type of viral transport media.

Abbott began advising customers in mid-April that ID NOW is a rapid test that was not designed for use with viral transport media. The company also recommended using dry nasal swabs to collect samples.

Today, the company announced an interim analysis of an ongoing clinical study at five urgent care clinics in New Jerse…

This wearable could help people practice safe distancing amid COVID-19

Image from Lopos

Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic.

As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.

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

This wearable could help people practice safe distancing amid COVID-19

Image from Lopos

Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic.

As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.

The Lopos SafeDistance wearable uses Lopos’ ultra wideband (UWB) technology originated from R&D at Imec and the Ghent University. When two wearables approach each other, the exact distance is measured and an alarm is activated when the minimum distance is not respected, according to a news release.

Having operated successful pilots at medium and large companies in the chemical, metal and construction industry, Lopos now intends to scale up to mass production. The company said in the rel…

Abbott to supply millions of its COVID-19 antibody tests to U.K. government

Abbott (NYSE:ABT) will supply millions of its laboratory-based COVID-19 antibody tests to the U.K.’s National Health Service over the coming months under a contract announced today.

The company has already shipped 800,000 of the IgG antibody test to NHS laboratories this week. The news comes on the same day that Abbott said that Health Canada has granted interim authorization for the IgG serology test, which last month received an FDA emergency use authorization in the U.S. and CE Mark in the EU.

The IgG test runs on Abbott’s Architect i1000SR and i2000SR and Alinity i laboratory instruments. Widely used in laboratories around the world, the Architect system is able to run 100–200 tests per hour.

“Abbott is proud to support the NHS’ COVID-19 antibody testing strategy announced today, with agreement to supply antibody tests to NHS laboratories across the U.K.,” said Mike Clayton, Abbott’s managing director of Northern …