Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19.
The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release.
Get the full story at our sister site, MassDevice.
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19.
The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release.
Eurofins’ CE-Marked INgezim dual-recognition immunochromatographic assays determine the presence of total antibodies (IgG, IgA and IgM) specific to SARS-CoV-2 in a single blood, serum and plasma sample by using nucleoprotein as an antigen to detect the antibodies.
Kits for the assay include all materials needed to perform the finger-prick test, with analysis capable of being performed outside a laboratory, although the tests are intended for use by healthcare professionals and not for self-diagnosis.
According to the release, more than 400 sera samples were observed to validate the assays, as no cross-reactivity…
Smith & Nephew (NYSE:SNN) said today it expects second-quarter revenues to dip by 29% due to the coronavirus pandemic, although results gradually improved as time went on.
Sales were hardest hit in the company’s orthopedic reconstruction, sports medicine and ENT businesses due to the pandemic-related lockdown and pause in elective surgeries. The company’s advanced wound management and trauma businesses fared better, executives said in a statement, but “significant uncertainty and geographical variation” persist, they added.
While the revenue drop is in line with SNN’s previously published outlook, sales gradually improved over the quarter, with revenue declines of -47% in April, -27% in May and -12% in June, they noted.
“As a result of the trading performance across the first and second quarters, we continue to expect that the first half trading margin will be substantially down on the prior year,” company of…
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination.
[Image courtesy of Mayo Clinic]
As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier this year.While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic.
One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment (PPE) such as masks and face shield…
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights.
[Gavel image from Unsplash. Coronavirus image from WHO]
Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits.“I say, ‘I sleep great at night because the companies I represent make things that can save and sustain life,’” said Thompson, who is vice chair of the Pharmaceutical, Medical Device & Health Care Litigation Practice at Greenberg Traurig.
Thompson thinks the case in defense of medtech is even stronger now that Americans and people around the world desperately need medical devices, drugs and vaccines to overcome the COVID-19 pandemic.
“Both drug and device companies want to help. A lot of our client…
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights.
[Gavel image from Unsplash. Coronavirus image from WHO]
Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits.“I say, ‘I sleep great at night because the companies I represent make things that can save and sustain life,’” said Thompson, who is vice chair of the Pharmaceutical, Medical Device & Health Care Litigation Practice at Greenberg Traurig.
Thompson thinks the case in defense of medtech is even stronger now that Americans and people around the world desperately need medical devices, drugs and vaccines to overcome the COVID-19 pandemic.
“Both drug and device companies want to help. A lot of our clien…
FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today.
The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called “Development and Licensure of Vaccines to Prevent COVID-19″ that provides a host of guidelines for vaccine developers.
The goal of the guidance is to ensure that the rush to produce a COVID-19 vaccine results in vaccines that are both safe and effective.
Get the full story on our sister site Drug Discovery & Development.
FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today.
The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called “Development and Licensure of Vaccines to Prevent COVID-19″ that provides a host of guidelines for vaccine developers.
The goal of the guidance is to ensure that the rush to produce a COVID-19 vaccine results in vaccines that are both safe and effective.
Get the full story on our sister site Drug Discovery & Development.
[Image courtesy of World Health Organization]
FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today.The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called “Development and Licensure of Vaccines to Prevent COVID-19″ that provides a host of guidelines for vaccine developers.
The goal of the guidance is to ensure that the rush to produce a COVID-19 vaccine results in a vaccine that is both safe and effective.
“While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards. This is particularly important, as we k…
Today, 340 companies signed a letter sent to Congress to urge leaders to make COVID-19-related telehealth flexibilities permanent.
Representing all 50 states, Washington, D.C., and Puerto Rico, the signees are seeking to stop the potential for telehealth flexibilities to disappear, should Congress fail to act before the COVID-19 public health emergency expires, according to a news release.
At the beginning of the pandemic, Congress waived statutory barriers to allow for expanded access to telehealth, offering federal agencies the flexibility to allow healthcare providers to deliver care virtually. The letter says that those flexibilities will immediately go away if Congress doesn’t act.
The 340 stakeholders who signed the letter urged Congress to remove obsolete restrictions on the location of the patient so care can be accessed at home, maintain and enhance Dept. of Health & Human Services (HHS) authority to determine appropriate providers for…
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination.
[Image courtesy of Mayo Clinic]
As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier this year.While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic.
One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment (PPE) such as masks and face shiel…
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination.
[Image courtesy of Mayo Clinic]
As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier this year.While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic.
One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment (PPE) such as masks and face shiel…