Dexcom CEO sees a new market for continuous glucose monitors after COVID-19

Dexcom CEO Kevin Sayer

Could in-hospital use of continuous glucose monitors become a new normal after the COVID-19 pandemic? Dexcom CEO Kevin Sayer thinks so.

As the pandemic ramped up in March, FDA issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance included CGMs made by companies such as Dexcom (NSDQ:DXCM) and Abbott (NYSE:ABT).

Preliminary data suggest that CGMs helped, according to Sayer, who spoke with MassDevice today as part of a virtual version of the American Diabetes Association’s annual Scientific Sessions. (Hear some clips during our DeviceTalks Weekly podcast at the end of the week.)

“We’ve even heard stories of patients who came in and they were about to ventilate them, and then they realized maybe their glucose values were out of control. Getting their glucose values unde…

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Moody’s lowers its medical device industry earnings forecast

Medical device industry earnings will remain flat over the next 12 to 18 months as people hold off on medical procedures amid the COVID-19 pandemic and resulting recession, according to a new report from Moody’s.

Moody’s had previously projected of 2–4% annual growth.

“While underlying positive trends remain, including ongoing innovation and favorable longterm demographics, we expect some consumers will be slow to return to the healthcare system,” the Moody’s analysts said in the report, out June 11.

“While many procedures are already being rescheduled in certain regions, some consumers will be unable to pay for their procedures due to the economic downturn, as well as their unwillingness to engage with the healthcare system while the coronavirus outbreak persists.”

The predictions from Moody’s come at the same time that medtech industry stocks are taking a hit, along with the overall markets, amid i…

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3M announces sizable sales dips in May

3M (NYSE:MMM) announced today that it experienced a -20% sales decline year-over-year for the month of May as the COVID-19 pandemic continues to impact business.

The St. Paul, Minn.-based company’s 20% dip brought sales down to $2.2 billion, with organic local-currency sales dropping -21%, although acquisitions and net of divestitures increased sales by 2%. Foreign currency translation reduced sales by -1%, according to a news release.

3M’s total sales dropped -11% in healthcare, -12% in consumer, -17% in safety & industrial and -30% in transportation and electronics. The total sales were hit hardest by a -26% drop in Europe, the Middle East & Africa, with a -21% overall decline in the Americas and a -15% dip in Asia Pacific.

This decrease across segments follows an announcement from 3M that its health care revenue was up 5% year-over-year for the month of April. Since January, 3M has doubled its global output of respirators to 1.1 bi…

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Philips launches remote fetal monitor for high-risk pregnancies during COVID-19

Royal Philips (NYSE:PHG) announced today that it launched an addition to its remote patient monitoring platform for at-risk populations during the COVID-19 pandemic.

Amsterdam-based Philips added the Avalon CL fetal and maternal pod and patch for reducing unnecessary physical interactions between clinicians and patients to prevent transmission of the coronavirus. The patch makes up part of a high-risk pregnancy platform that includes Philips perinatal analytics and visualization, along with a portable, battery-operated fetal monitor.

The single-use, 48-hour disposable electrode patch placed on the mother’s abdomen allows for continuous, non-invasive monitoring for maternal heart rate, fetal heart rate and uterine activity. It only requires placement once, unlike traditional belts and sensors that require frequent repositioning, according to a news release.

Philips’ Avalon CL won CE Mark approval in 2019 and is commercially available in severa…

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Mayo Clinic launches test to detect COVID-19 immunity

Mayo Clinic announced that it launched a new SARS-CoV-2 neutralizing antibody test in support of efforts to establish therapies and vaccines for COVID-19.

As part of the Expanded Access Program for Convalescent Plasma and other critical research efforts, Mayo Clinic intends to make the test available to select labs, blood banks and biopharma clients later this month.

Mayo Clinic designed the new test to measure the level of neutralizing antibodies against SARS-CoV-2, the virus causing COVID-19. The test provides semi-quantitative detection of total neutralizing antibodies in human serum. After infection, most will develop an immune response to COVID-19, including the production of neutralizing antibodies against the SARS-CoV-2 spike glycoprotein. However, it’s currently unknown for how long the neutralizing antibodies persist after infection.

The test should only be ordered upon confirmation of prior infection and it should not be used to diagnose …

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Siemens Healthineers wins EUAs for additional COVID-19 antibody tests

More than a week after granting EUAs for COVID-19 antibody tests produced by Siemens Healthineers (ETR: SHL), FDA has authorized additional tests from the German medtech giant.

The new EUAs, granted June 8, are for tests running on Siemens Healthineers Dimension Vista and Dimension® EXL systems. The tests already started shipping on May 29.

Siemens Healthineers previously announced EUAs for comparable tests running on Atellica IM immunoassay analyzers and Advia Centaur XP and XPT analyzers.

The company is making the tests in Walpole, Mass. and Newark, Del., and distributing them out of Plainfield, Ind. It’s ramping up production, with a goal of manufacturing capacity exceeding 50 million tests per month across its testing platforms.

 

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New web resource keeps vaccine researchers up-to-date on COVID-19 protein structures

[Image courtesy of Marcin Minor, for University of Virginia]

Wladek Minor of the University of Virginia and other top structural biologists have created a Web resource so that scientists can track the progress of investigations into COVID-19 protein structures.

The website also includes the research team’s assessment of the quality of the individual models. It includes enhanced versions of the protein structures when possible.

“We have carefully analyzed the available models of SARS-CoV-2 proteins and present the results with the aim of helping the broad biomedical community. Structural models are ultimately the interpretation of the original researchers and sometimes are suboptimal. This is why a second set of eyes to validate important structures is so crucial,” Minor said in a news release.

Read the full story on our sister site R&D World. 

 

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Grifols starts production of COVID-19 prevention drug

Grifols (NSDQ:GRFS) announced today that it began production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies for combating COVID-19.

Barcelona-based Grifols touts the prevention drug, developed from the plasma of people who have overcome the disease, as the first specific drug developed to fight COVID-19, according to a news release.

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

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Grifols starts production of COVID-19 prevention drug

Grifols (NSDQ:GRFS) announced today that it began production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies for combating COVID-19.

Barcelona-based Grifols touts the prevention drug, developed from the plasma of people who have overcome the disease, as the first specific drug developed to fight COVID-19, according to a news release.

The company is producing the potential anti-COVID-19 therapy in a collaboration agreement with the FDA, the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA) and other U.S. healthcare agencies. It is also moving forward to establish collaborations in Europe.

Grifols is producing the hyperimmune immunoglobulins at its Clayton, N.C., facility and anticipates the first doses to be available next month as part of a clinical trial.

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Regeneron launches clinical trial of COVID-19 antibody ‘cocktail’

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that it initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19.

The REGN-COV2 clinical program will include populations of hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that have a high risk of exposure (healthcare workers or first responders, for example) and uninfected people with close exposure to a COVID-19 patient (such as a housemate). The placebo-controlled trials will be conducted at multiple sites, according to a news release.

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

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Regeneron launches clinical trial of COVID-19 antibody ‘cocktail’

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that it initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19.

The REGN-COV2 clinical program will include populations of hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that have a high risk of exposure (healthcare workers or first responders, for example) and uninfected people with close exposure to a COVID-19 patient (such as a housemate). The placebo-controlled trials will be conducted at multiple sites, according to a news release.

Using its proprietary genetically modified VelocImmune mice, which have a human immune system and antibodies isolated from humans who recovered from COVID-19, Regeneron scientists evaluated thousands of fully human antibodies. They then selected the two most potent, non-competing and virus-neutralizing antibodies and scaled them up for clinical use. The antibodies bind non-competiti…

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ThermoGenesis files for patent on device to improve COVID-19 antibody detection

ThermoGenesis Holdings (NSDQ:THMO) announced today that it filed patent applications for its point-of-care COVID-19 antibody detection device.

Rancho Cordova, Calif.-based ThermoGenesis’ device is designed to improve the speed and accuracy of lateral flow immunoassays (LFIA) in detecting COVID-19 IgM and IgG antibodies from a single drop of blood.

In a news release, ThermoGenesis chief technology officer Phil Coelho described the LFIA reader as a device that will enable the user to slide the test cartridge into a portable reader and receive an instant readout that can be immediately recorded into a corporate database or cloud-based web portal to offer insight into the spread of COVID-19 seropositivity in real-time.

“Today’s LFIAs, in certain cases, are challenging for untrained users to properly read when results are indicated by weakly stained bands,” Coelho said. “Variances among patients, if not read properly, could gener…

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