covid-19 Archives - Page 105 of 113 - Medical Design Sourcing

3M sues seller of fake and damaged N95 respirators

3M (NYSE:MMM) announced that it filed a legal action in federal court alleging that a seller on Amazon inflated prices of fake, defective and damaged N95 masks.

N95 masks have been in high demand as the COVID-19 pandemic roars on. In April, the U.S. Defense Dept. awarded a $76 million contract to 3M to produce the respirators under the Defense Production Act (DPA) and the company announced two more DoD contracts last month.

The lawsuit alleges that Mao Yu and affiliated companies defrauded customers by charging the inflated prices for the fake and damaged respirators, falsely advertising as third-party sellers under the 3M brand. The company alleges that the defendants charged unsuspecting customers more than $350,000 when they responded to false listings claiming to be selling authentic N95 masks.

3M’s allegations state that the defendants charged prices that exceed as much as 20 times the list prices for 3M’s N95 respirators. Amazon learned…

BioMedInnovations gains EUA for ventilator

BioMedInnovations announced today that it received FDA emergency use authorization (EUA) for its SuppleVent ventilator technology.

With the EUA, the SuppleVent system becomes the latest alternative ventilator to gain some form of authorization to assist during the COVID-19 pandemic.

Denver, N.C.-based BioMedInnovations’ proprietary back-pressure regulator (BPR) technology was designed in collaboration with Lawrence Livermore National Laboratory (LLNL) and partners Equilibar Precision Pressure Control and Roush Yates Manufacturing Solutions.

SuppleVent includes a clinician-friendly interface with full alarms and low power operation from a compressed gas source, along with forward flexibility in the architecture to add displays, data logging, wireless communication, closed-loop control and other features.

The ventilator accepts 50psi compressed air or oxygen mix and is powered by a110V/220V AC outlet or optional DC battery supply, according to…

Harvard’s Wyss Institute wants to create a COVID-19 antibody test strip

[Image courtesy of The iQ Group Global]

The iQ Group Global announced today that it has inked a collaboration with Harvard’s Wyss Institute to develop a printable point-of-care SARS-CoV-2 antibody test with real-time results.

Life Science Biosensor Diagnostics, the iQ Group’s development company, has been working on the Australian-invented Biosensor Platform, a printable organic thin-film transistor “strip” that has the potential to provide a variety of medical tests — and even potentially replace blood glucose finger stick tests for diabetics. The Wyss Institute for Biologically Inspired Engineering at Harvard University has meanwhile created a special coating that can detect IgM and/or IgG antibodies.

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

Harvard’s Wyss Institute wants to create a COVID-19 antibody test strip

[Image courtesy of The iQ Group Global]

The iQ Group Global announced today that it has inked a collaboration with Harvard’s Wyss Institute to develop a printable point-of-care SARS-CoV-2 antibody test with real-time results.

Life Science Biosensor Diagnostics, the iQ Group’s development company, has been working on the Australian-invented Biosensor Platform, a printable organic thin-film transistor “strip” that has the potential to provide a variety of medical tests — and even potentially replace blood glucose finger stick tests for diabetics. The Wyss Institute for Biologically Inspired Engineering at Harvard University has meanwhile created a special coating that can detect IgM and/or IgG antibodies.

A new pilot study will test the integration of the Biosensor Platform with the Wyss coating for spotting COVID-19 antibodies. The eventual goal is a chewing-gum-sized diagnostic &…

Nuvaira gains FDA breakthrough nod for lung denervation system

Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device.

The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD and asthma.

The system is designed to reduce the risk of worsening moderate-to-severe chronic obstructive pulmonary disease (COPD) in patients on optimal medical care, according to Minneapolis-based Nuvaira. In March, the FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s Airflow-3 pivotal trial resulted in FDA investigational device approval for the company to complete the 400-patient study, Nuvaira noted. In April, the Centers for Medicare & Medicaid Services (CMS) approved Medicare coverage of the Airflow-3 trial.<…

It may become easier to disinfect with UV-C LEDs

Transmission of 10-nm-thick freestanding films of SrNbO3 and SrVO3. The shaded region labeled UV indicates the spectral range the researchers used to calculate a figure of merit in transmitting UV.

UV radiation in the 200 to 300-nm range (dubbed the UV-C range) can destroy viruses, including the novel coronavirus. The problem is, doing so requires UV radiation sources putting out sufficiently high doses of UV light.

That typically means using a relatively expensive mercury gas discharge lamp. It’s possible to find sources employing LEDs that put out UV-C, but the light they put out is typically weak, too weak to do much good for disinfection purposes. One reason: Their light emission is complicated by the fact that their electrode material must also be transparent to UV-C.

Get the full story on our WTWH Media sister site Power Electronic Tips.

Sherlock Biosciences announces manufacturing partnership for CRISPR-based COVID-19 test

Sherlock Biosciences announced today that it will collaborate with Integrated DNA Technologies (IDT) to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for COVID-19 detection.

Officials at Cambridge, Mass.–based Sherlock Biosciences think the company’s CRISPR-based diagnostic test, which recently received an FDA emergency use authorization, will increase testing capacity and decreasing time to result amid the coronavirus pandemic.

Get the full story on our sister site Pharmaceutical Processing World.

FDA restricts re-use of certain respirators for COVID-19

Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today.

The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on test results from the National Institute for Occupational Safety and Health (NIOSH).

The agency also revised the EUAs for certain decontamination systems so they are are no longer authorized to decontaminate non-NIOSH-approved respirators manufactured in China. These systems now may only decontaminate NIOSH-approved, non-cellulose respirators that do not have an exhalation valve as well as certain imported, non-NIOSH-approved respirators with exhalation valves.

Manufacturers with revised EUAs include Stryker, Duke, Advanced Sterilization Products, Sterilucent, Steri…

MedTech 100 roundup: Stocks stand pat in June’s first week

While the markets experienced some growth over the past week, stocks in the medtech industry remained practically unchanged over seven days.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.15 points at the end of last week (June 5). That total represents just a -0.02-point decrease from the 87.17-point total at the same time a week prior (May 29), which represented the industry’s highest point since before the COVID-19 pandemic took hold of the markets.

Meanwhile, the S&P 500 Index experienced a 3.14% increase from May 29 to June 5 and the Dow Jones Index fared even better with a 6.81% increase over the same period of time. The market surge came on the back of the White House announcement that 2.5 million jobs were added in May and unemployment rose to 13.3% when a surge to nearly 20% was expected, according to Yahoo Finance.

The lowest point for medtech during the COVID-19 pand…

FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests

Hologic’s Panther system (Image from Hologic)

The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas.

Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach can interact with transport media containing guanidine thiocyanate or similar chemicals to produce deadly cyanide gas, according to the agency. Guanidine thiocyanate may be referred to as guanidinium rhodanide, guanidinium thiocyanate or guanidinium.

While there have been reports of these potentially hazardous interactions, there have been no injuries reported to the FDA associated with exposure to cyanide gas as a result of using incompatible media with testing platforms.

Nu…

Clew Medical gains EUA for predictive screening software for COVID-19

Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive care units.

The EUA covers the company’s ClewICUServer and ClewICUnitor. The system is a standalone software that is designated as a medical device. It uses commonly recorded vital signs, nursing assessments, flowsheet data, medications and lab data to compute patient status indexes.

Data defined by the system includes CLEWRF, which is a measure of a patient’s predicted physiologic condition within the next eight hours based on the aggregate statistical risk of respiratory deterioration or failure, and CLEWHI, which is a measure of a patient’s predicted physiological condition within the next eight hours based on the aggregate statistical risk of hemodynamic instability.

The system is cleared for use in adults in ICU while treating COVID-19 as a diagnostic aid with the early identification of patients who are likely to experience r…

Survey: Half of heart attack patients avoid the hospital during pandemic

The number of heart attack patients seeking urgent hospital care has dropped by more than 50% worldwide during the COVID-19 outbreak, according to a survey by the European Society of Cardiology (ESC).

The survey of 3,101 healthcare professionals in 141 countries was conducted in mid-April.The findings are published in European Heart Journal — Quality of Care and Clinical Outcomes.

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