LivaNova LifeSparc ACS pump cleared for extended use

LifeSparc includes a sterile, on-patient pump. The reduced circuit surface area decreases inflammatory response and eliminates the need for a heater/cooler. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO).

The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic.

In a news release posted yesterday, London-based LivaNova said it used existing real-world evidence to receive the new indication. The evidence included data collected during the pandemic.

“The onset of the global pandemic elevated ECMO to the forefront as an effective treatment option for patients in need of emergent rescue who had limited, if any, options,” said Dr. Raymond Yau, director of Cardiogenic Shock at the Heart H…

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Bio-Rad stock dips as COVID-19-related sales taper off in Q3

Bio-Rad (NYSE:BIO) shares took a hit on third-quarter results that came in mixed compared to the consensus forecast.

BIO shares were down more than 6% at $359.75 apiece this morning — a day after the company released its results. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down more than 2%.

The Hercules, California–based clinical diagnostics company posted losses of $164.2 million for the quarter. That’s a loss of $5.52 per share on sales of $680.8 million for the three months ended Sept. 30, 2022.

Bio-Rad registered a massive bottom-line slide into the red on a sales decline of 8.9%. Life sciences sales sank by 14.9% for the quarter. Lower COVID-related sales, legal settlements in the year-ago period and supply chain constraints led to the dip. Excluding COVID-19-related sales and legal settlements, the segment grew by 9.4%.

Additionally, Bio-Rad’s clinical diagnostics …

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3M launches Verify platform to spot counterfeit products

3M (NYSE:MMM) announced today that it established a new 3M Verify platform to report potential counterfeit 3M products.

The effort builds upon its anti-counterfeit efforts during the height of the COVID-19 pandemic. At the time, a number of sellers claimed to offer 3M respirators. Instead, many offered fake, defective and damaged N95 masks at inflated prices.

St. Paul, Minnesota-based 3M worked closely with law enforcement and governments around the world to stop counterfeit 3M respirators and COVID-19-related fraud. According to a news release, the company seized more than 58 million counterfeit respirators. It removed tens of thousands of fraudulent e-commerce offerings and suing wrongdoers to stop misleading schemes targeting frontline workers.

3M said the platform expands its counterfeit reporting process to include all products made by the company. The platform can be found HERE. It offers resources and information to help customers, distributors, e…

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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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Vaxxas receives more than $5 million grant for vaccine delivery patch

Vaxxas’ patch comes in a hockey-puck-shaped applicator with a foil seal. [Image courtesy of Vaxxas]Vaxxas announced today the Australian government is granting it nearly $5.5 million for the manufacturing of its vaccine delivery device.

Cambridge, Massachusetts-based Vaxxas picked up AU$8.2 million ($5.48 million). The second-round grant represents part of the Australian government’s Modern Manufacturing Initiative (MMI). Funding supports the manufacturing scale-up of Vaxxas’ device for applying vaccines to the skin using a small patch.

Get the full story at our sister site, Drug Delivery Business News.

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Medtech sales reach a record high as R&D spend and employee counts climb

The Medtech Big 100: The world’s largest medical device companies

The medtech industry is bouncing back from the economic fallout caused by the COVID-19 pandemic, according to an analysis of our Medtech Big 100 data.

The medical device industry has seemingly recovered from the economic headwinds caused by the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data from the Medtech Big 100, 100 of the largest medical device companies’ most recent annual results.

More than half of the companies listed in this year’s Big 100 ranking reported positive growth over their prior-year sales. Total revenue, research spending and employment figures were up significantly as the industry adjusts to a world with COVID-19 challenges.

For this analysis, we compared the performance of the Medtech Big 100 companies in 2021 and early 2022 with their results in 2020. Due to t…

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Medtech executive convicted of COVID-19 tests fraud

A federal jury convicted the president of a medtech company — Arrayit — accused of participating in a scheme to mislead investors over COVID-19 tests.

In June 2020, the U.S. Department of Justice (DOJ) charged Arrayit president March Schena for alleged involvement with fraudulent claims for allergy and COVID-19 testing. The charges alleged a scheme to mislead investors, commit health care fraud, and pay illegal kickbacks in connection with the submission of over $77 million in false and fraudulent claims for COVID-19 and allergy testing.

Schena, 59, engaged in a scheme to defraud Arrayit’s investors, according to court documents and evidence presented at trial. He allegedly claimed he invented revolutionary technology to test for virtually any disease using just a few drops of blood.

In a 2020 affidavit in support of the claim, Schena claimed that Sunnyvale, Calif–-based Arrayit was the only laboratory in the world offering microarray technology th…

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CHMP backs updated Pfizer/BioNTech and Moderna COVID-19 boosters

[Image courtesy of Pixabay.]

EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing bivalent COVID-19 vaccines from Pfizer/BioNTech and Moderna.

The boosters target the omicron BA.1 sublineage.

Assuming the European Commission follows CHMP’s recommendations, the European vaccine campaign will use bivalent vaccines targeting the original version of the omicron variant.

U.S. regulators, by contrast, have backed the use of bivalent vaccine boosters that target the BA.4/BA.5 sublineages of omicron. While Pfizer/BioNTech (NYSE:/PFE, Nasdaq: BNTX) and Moderna (Nasdaq:MRNA) have both developed vaccine boosters based on BA.4/BA.5, there is currently no human data for those vaccines. Instead, FDA is relying on data from earlier vaccine versions and preclinical data.

EMA’s recommended that the updated boosters be used in individuals at least 12 years of age who have…

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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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European authorities begin review of Skycovion COVID-19 vaccine candidate

The European Medicines Agency (EMA) has begun an evaluation of a conditional marketing authorization application for the Skycovion (GBP510) COVID-19 vaccine candidate from SK Chemicals GmbH.

Skycovion is a recombinant protein-based vaccine with adjuvant from GSK.

In its filing, SK Chemicals provided data on how efficacious the vaccine is at creating antibodies against ​wild-type COVID-19. In addition, the company shared safety and quality data with the EMA.

Skycovion won approval for the vaccine in South Korea in June.

After the Committee for Medicinal Products for Human Use (CHMP) reviews the application, the European Commission will make a legally binding decision.

A unique vaccine

Skycovion is a recombinant protein-based vaccine based on the genetically produced modified spike protein of the Wuhan stream of SARS-CoV-2. The vaccine uses nanoparticles to encode for the spike protein.

SK Chemicals is headquartered in Seoul, South Kor…

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Next-gen Pfizer-BioNTech vaccine candidates fare well in Phase 2/3 study

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates.

One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant.

A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led to a significantly higher immune response against omicron BA.1 than the companies’ original vaccine.

Booster doses of 30 µg and 60 µg generated a robust immune response in the Phase 2/3 study.

In the U.S., the BA.1 variant is responsible for a single-digit percentage of COVID-19 infections.

The company plans on sharing the data with the scientific community and health authorities to accelerate the potential introduction of an omicron-adapted booster “as soon as possible if authorized by regulators,” said Pfizer CEO Dr. Albert Bourla.

“Omicron has ne…

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