covid-19 Archives - Page 107 of 113 - Medical Design Sourcing

Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment

The Medtronic Affinity CP centrifugal blood pump [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19.

ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic has devices that are FDA-cleared for extracorporeal support of up to 6 hours — an appropriate amount of time for cardiopulmonary bypass procedures (up to 6 hours).

In accordance with a new FDA guidance, Medtronic says the following devices can now be used for longer than 6 hours in an ECMO circuit to treat people experiencing acute respiratory/cardiopulmonary failure during the COVID-19 pandemic:

The Bio-Console 560…

FDA wants to streamline development of at-home COVID-19 diagnostic tests

The FDA announced that it took steps in an effort to support the development of COVID-19 tests for at-home self-collection.

Creating a voluntary emergency use authorization (EUA) template outlining the guidelines for at-home sample collection kits is among the steps the agency has taken, according to a news release. The template includes recommendations for laboratories and commercial manufacturers as they seek EUA.

Developers right now can offer a COVID-19 test for at-home self-collection under EUA and those tests can also be used as part of an institutional review board (IRB)-approved study.

Generally, developers are required to submit a request for EUA prior to the distribution and use of an at-home COVID-19 test. When they have not obtained EUA, the tests can be used as part of a research study that complies with the FDA’s requirements for device investigations.

The FDA has granted authorization to at-home COVID-19 tests that provide sam…

Gallup has a new poll that medtech should care about

[Photo by Online Marketing on Unsplash]

Fewer Americans are worried about going to the doctor amid the COVID-19 pandemic, according to a new online poll from Gallup.

The poll provides good news for the medical device industry as it seeks to recover from a dropoff in elective procedures — and even procedures that people need — as hospitals focus on treating people suffering from the coronavirus.

Gallup found 22% of Americans during the May 14–24 time period were very concerned about COVID-19 exposure during a visit to a doctor’s office or hospital, down more than 20 percentage points from the 44% registered March 28–April 6.

The poll found 42% were moderately concerned — about the same level as the 40% recorded in late March and early April.

Meanwhile, 26% of respondents were not too concerned, and 11% were not concerned at all — up from 13% and 3% respectively in the previous poll. Read more

Medtech 100 roundup: Stocks peak to end May

Medtech stocks hit their highest point since before the COVID-19 pandemic rocked the markets as May came to a close last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.17 points at the end of last week (May 29). That total represents a 2.3% gain from the 85.22-point total at the same time a week prior (May 22).

The lowest point during the pandemic remains at 62.13 on March 23. Since then, medtech stocks have experienced 40.3% growth in total, marking the highest rise the index has seen since its previous mid-pandemic high of 85.77 on May 4.

However, the stocks are down 5.6% since the index’s pre-pandemic crash high point of 92.32 on Feb. 19, although that is the smallest margin of decline over the past three months.

Compared to the S&P 500 Index, which experienced a 3% increase from May 22 to May 29, the medtech index took a similarly sizeable leap. The Dow Jones Index f…

Siemens Healthineers secures EUA for its COVID-19 antibody test

Siemens Healthineers (ETR: SHL) announced today that it has secured an FDA emergency use authorization for its COVID-19 antibody test.

The news comes nearly a week after the German medtech giant said it had started worldwide shipments of the test — a laboratory-based total antibody test that can detect SARS-CoV-2 antibodies including IgM and IgG in blood. The company already has more than 1 million tests shipped to health systems and laboratories.

Antibody tests are an important tool as countries reopen their economies amid the COVID-19 pandemic: They can tell who has had the coronavirus in the past and hopefully developed some immunity. Siemens Healthineers, in fact, designed its Total Antibody COV2T assay to detect antibodies to the spike protein, which are believed to neutralize the SARS-CoV-2 virus and therefore prevent infection.

“As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with …

FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure.

The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data on the device that showed a survival rate matching that of its pre-approval study when following the FDA’s approved protocol.

During the COVID-19 pandemic, Impella RP has been used for treating right heart failure or decompensation, including pulmonary embolism, according to a news release. It can be deployed in minutes using a minimally invasive technique.

The FDA granted EUA based on data from Impella RP’s approved indication and reported clinical experience. Under the authorization, healthcare providers may use the device in a hospital setting when providing temporary …

FDA adds reference panel to study COVID-19 diagnostics

The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19.

Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency.

Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA), and the FDA said its new reference panel provides developers access to this material.

The agency described it as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. It is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests,” said Jeffrey Shuren, director of the FDA’s Center for Devi…

Quest lands FDA nod for at-home COVID-19 test

(Image from Quest Diagnostics)

Quest Diagnostics (NYSE:DGX) has received an FDA emergency use authorization (EUA) for an at-home diagnostic test for COVID-19.

The Secaucus, N.J.-based testing giant said the test kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. It allows an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature and patients can obtain results through the myQuest patient portal and mobile app. Quest said it will report test data to the relevant departments of health as required.

Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an EUA in March. RT-PCR testing aids in diagnosing infection with SARS-Co…

Poll: Patients want to return to the doctor

AdvaMed said polling data confirmed that nearly half of American adults surveyed said they or someone in their household postponed or skipped medical care as a result of COVID-19.

The poll, released yesterday by the Kaiser Family Foundation showed that 48% of those adults or adults in their household had to put off medical care during the pandemic. It also revealed that 68% of those who postponed care expect to receive that care in the next three months, while 11% of respondents reported worsened health as a result of the delay in care.

“We already knew that too many patients have been going without the care that is absolutely vital to their health, and what this poll confirms is that patients themselves are anxious and ready to continue the care that was put on pause because of COVID-19,” AdvaMed president & CEO Scott Whitaker said in a news release. “It’s time for these essential medical procedures to resume. Last week, we joined AORN and AHA in releasing…

Merck eyes tiny patches as a vaccine delivery method

Vaxxas’ High Density Microarray Patches (HD-MAP)

Merck has exercised its option to use Vaxxas‘ High Density Microarray Patch (HD-MAP) platform as a delivery platform for a vaccine candidate, the companies announced today.

The companies did not disclose what the vaccine candidate is supposed to treat. But Merck this month announced two COVID-19 vaccine development efforts: a collaboration with IAVI and plans to acquire vaccine developer Themis Bioscience. Vaxxas (Cambridge, Mass.; Brisbane, Australia) notes that any vaccine could be delivered with its dime-sized patch.

Also today, Vaxxas announced that German manufacturing equipment maker Harro Höfliger will help Vaxxas develop a high-throughput, aseptic manufacturing line to make vaccine products based on Vaxxas’ HD-MAP technology — with a goal of eventually churning out millions of vaccine patches a week.

Get the full story on our …

ReWalk Robotics posts COVID-19-affected Q1 losses

ReWalk Robotics (NSDQ:RWLK) shares ticked up slightly today despite first-quarter results that came up short of the consensus forecast.

The Yokneam Illit, Israel–based robotic walking assistance company posted losses of $3.8 million, or -37¢ per share, on sales of $760,000 for the three months ended March 31, 2020, for a 4% bottom-line gain on a sales decline of 51.9%.

Adjusted to exclude one-time items, earnings per share were 34¢, 8¢ behind Wall Street, where analysts were looking for sales of $2.2 million.

The company noted in a news release that its quarter was heavily impacted by the COVID-19 pandemic, with some of its products unable to be delivered due to restrictions brought on by the virus.

“The first quarter of 2020 was challenging as we had the COVID-19 pandemic affecting our ability to meet, train and deliver our products to customers,” ReWalk CEO Larry Jasinski said in the news release. “We have reacted to the new environment…

Merck eyes tiny patches as a vaccine delivery method

Vaxxas’ High Density Microarray Patches (HD-MAP)

Merck has exercised its option to use Vaxxas‘ High Density Microarray Patch (HD-MAP) platform as a delivery platform for a vaccine candidate, the companies announced today.

The companies did not disclose what the vaccine candidate is supposed to treat. But Merck this month announced two COVID-19 vaccine development efforts: a collaboration with IAVI and plans to acquire vaccine developer Themis Bioscience. Vaxxas (Cambridge, Mass.; Brisbane, Australia) notes that any vaccine could be delivered with its dime-sized patch.

“We are excited by this latest milestone in our collaboration with Merck, an early adopter of our novel HD-MAP platform,” Vaxxas CEO David L. Hoey said in a news release. “With their strong legacy of vaccine development Merck is a tremendous partner in our efforts to enhance the efficiency, effectiveness, and reach of v…