Dexcom focuses on early diabetes diagnosis as COVID links emerge

Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.

In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.

Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.

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

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Dexcom focuses on early diabetes diagnosis as COVID links emerge

Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]

New data is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.

In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.

Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.

The following has been lightly edited for space and clarity.

MDO: How does the SARS-CoV-2 virus and its COVID-19 disease affect the pancreas?

Walker: In February, March of 2020, there were a couple of papers published out of China very early in the expe…

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How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.

The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.

The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.

SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22 COVID-19 patients with multiple organ failure in ICUs. The treatment reduced mortality to 50% (compared to 81% in the control group), while patients who used the device for more than 96 hours saw…

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How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]

SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.

The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.

The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.

SeaStar Medical CEO Eric Schlorff [Photo courtesy of SeaStar Medical]

SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22…
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Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

Dr. Philip Adamson is chief medical officer of Abbott’s heart failure business [Photo courtesy of Abbott]Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body.

What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, even in mild cases. This once-in-a-century pandemic that has already killed millions across the globe could leave hundreds of millions more with chronic conditions varying in acuity.

“Not only is the viral infection bad for some people, but the subsequent body’s reaction to the viral illness in many people is remarkable. I personally have never seen anything like it,” said Dr. Philip Adamson, chief medical officer of Abbott’s heart failure business. “I’ve lived through and trained through the AIDS epidemic and learned a lot abo…

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Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

Dr. Philip Adamson is chief medical officer of Abbott’s heart failure business [Photo courtesy of Abbott]

Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body.

What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, even in mild cases. This once-in-a-century pandemic that has already killed millions across the globe could leave hundreds of millions more with chronic conditions varying in acuity.

“Not only is the viral infection bad for some people, but the subsequent body’s reaction to the viral illness in many people is remarkable. I personally have never seen anything like it,” said Dr. Philip Adamson, chief medical officer of Abbott’s heart failure business. “I’ve lived throu…

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Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in November 2020. The company said it hopes for its latest EUA ahead o…

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Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]

Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in Novem…

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An Amazon cloud conversation with AWS Chief Medical Officer Taha Kass-Hout

Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.

This conversation has been edited for clarity and length.

MDO: What d…

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Ultrasonically welded flow sensor critical to success of Hamilton Medical ventilator design

The body of the Hamilton Medical proximal flow sensor consists of two molded halves composed of medical-grade plastic. Between the two halves, a ring-shaped insert holds a delicate membrane with a variable orifice that detects changes in air direction and flow within the patient airway, transmitting inhalation/exhalation inputs to the ventilator digital control through two small tubes linked to the ports at center right. These inputs are used to minutely regulate air pressure and flow in real time. [Photo courtesy of Hamilton Medical]

The disposable sensor monitors ventilation of critically ill patients with high precision.

Didier Perret, Emerson

Hamilton Medical (Bonaduz, Switzerland) produces intelligent ventilation solutions for intensive-care units and critical-care transports. To meet the exploding demand for ventilators during the COVID-19 pandemic, Hamilton Medical established a new ventilator produ…

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Philips and DOD aim to detect COVID early with wearable devices and an algorithm

The Department of Defense’s Defense Innovation Unit and Philips are studying the ability of Garmin watches and Oura rings to collect data that can offer an early warning of COVID-19 infection. [Photo courtesy of the DOD Defense Innovation Unit]

Philips and the Pentagon are testing what they call “predictive bio-wearables” that can track changes in vital signs to offer an early warning of COVID-19 infection.

Philips and the DOD Defense Innovation Unit (DIU) have used Garmin watches — the Fenix 6 and Vivoactive 4 — and Oura rings on more than 11,000 test patients since June 2020, measuring respiration rate, oxygen saturation and heart rate with the watch and heart rate and skin temperature with the ring.

An algorithm watches for changes detected by the cloud-connected devices and offers a score from 1 to 100, with a higher number representing a higher likelihood of infection. The research…

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COVID-19 diagnostics sales boost Abbott’s Q2 results

Abbott (NYSE:ABT) beat the consensus forecast on Wall Street today — with sales of molecular diagnostics including COVID-19 tests more than tripling.

The Abbott Park, Ill.-based healthcare giant reported profits of $537 million or 57¢ per share, on sales of $7.33 billion for the three months ended June 30, 2020, for a bottom-line plunge of –47% on sales that dropped -8.2.% compared with Q2 2019.

After suspending its year-end forecast in April due to uncertainty related to the pandemic, Abbott projected EPS of $3.25 for the full year 2020, which compares with analysts’ projection of $2.87  per share.

Medical device sales were down more than -21% worldwide to $2.423 billion for the quarter, with diabetes care sales the only category in the black, with a 27.2% increase. Notably, the company received FDA clearance in mid-June for its FreeStyle Libre 2 continuous glucose monitoring system for adults and children ages four and older with diabetes.

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