How Abbott Became a Leader for COVID-19 Testing
Diagnostic companies across the world have stepped up over the past couple months to bring much-needed testing to the COVID-19 frontlines. But Abbott has emerged as a leading test maker in this battle as the company has launched three COVID-19 tests and has a fourth test on the way.
In late March, Abbott launched two molecular diagnostic tests designed to detect SARS-CoV-2, one for the company's ID Now rapid point-of-care platform, and one for its M2000 laboratory platform. Earlier this week the company launched a lab-based serology test for the detection of the antibody IgG, and CEO Robert Ford says the compan...
Source: MDDI - April 16, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news
Supplier Stories for the Week of April 12
(Source: MDDI)
Source: MDDI - April 16, 2020 Category: Medical Devices Authors: Daphne Allen Tags: 3-D Printing COVID-19 Source Type: news
Lab Validates Use of Co-Diagnostics & #039;s Covid-19 Test on Saliva Samples
Co-Diagnostics could be moving toward a saliva-based COVID-19 PCR test in the future. This comes as OralDNA Labs, a Clinical Laboratory Improvement Amendments-certified laboratory, has validated a COVID-19 PCR test based on the Co-Diagnostics CoPrimer technology for use with saline oral rinse samples.
The Salt Lake City, UT-based company said OralDNA labs notified FDA of the intent to use the validated test.
“This validation on the OraRisk line of salivary diagnostics showcases the versatility and flexibility of our CoPrimer platform and COVID-19 test,†Dwight Egan, Co-Diagnostics said i...
Source: MDDI - April 16, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
3D Printing of PPE and Other Medical Devices
During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and effi...
Source: MDDI - April 16, 2020 Category: Medical Devices Authors: Sean K. Burke Tags: Regulatory and Compliance Source Type: news
Ortho Clinical Diagnostics Picks up EUA for COVID-19 Total Antibody Assay
FDA continues to grant Emergency Use Authorization during the coronavirus crisis. This time the federal agency has granted EUA to Ortho Clinical Diagnostics for a total antibody assay for COVID-19.
The test is called the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.
The Raritan, NJ-based company said its COVID-19 total antibody test can help determine who can responsibly be permitted to go back to work by aiding in the identification of currently infected or previously exposed individuals who may have developed an immunity.
Ortho Clinical Diagnostics added that the test can also help ...
Source: MDDI - April 15, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
Device to Assist in Weaning Patients Off Ventilators is Granted EUA
Synapse Biomedical has received Emergency Use Authorization for the use of a technology that could have big implications for patients using ventilators going forward.
The TransAeris DPS is used to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off of ventilators in healthcare settings during the COVID-19 pandemic for no more than 30 days.
The Oberlin, OH-based company said the TransAeris system recently received CE Mark approval and that models suggest the technology could reduce ventilator burden in COVID-19 patients by 26%. This could, in turn, help free up more v...
Source: MDDI - April 15, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Source Type: news
FDA Grants EUA to First Saliva-Based Coronavirus Test
FDA has granted out a ton of emergency use authorizations for tests to detect the novel coronavirus. However, the federal agency’s latest EUA designation could be a first.
On Tuesday, Rutger’s RUCDR Infinite Biologics along with Spectrum Solutions and Accurate Diagnostics Labs (ADL) have developed an application that uses saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus.
The feeling is that the test will allow for broader population screening than the current method of nose and throat swabs.
In release, Andrew Brooks, COO and director of technology development at RUC...
Source: MDDI - April 15, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
Telemedicine Is Here to Stay
COVID-19 has prompted a rapid adoption of telemedicine, a trend that some experts say could have a significant and lasting impact on the medical device industry.
Jason Mills, a medtech analyst at Canaccord Genuity, shared conclusions earlier this week from three recent physician surveys that his firm conducted across the structural heart, robotic surgery, and stroke/venous thromboembolism fields. One of the key takeaways is that the overwhelming majority of doctors have "swiftly embraced" telemedicine during the crisis.
A look at some of the major telemedicine players' earnings projectio...
Source: MDDI - April 15, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Digital Health Source Type: news
AI-Powered CT Imaging System Shown to Detect COVID-19
“As COVID-19 continues to rapidly spread around the world, it is critical that we have all the solutions on the table, as healthcare systems and providers may become overwhelmed with symptomatic patients with severe or worsening respiratory status,†said Moshe Becker, CEO and co-founder of RADLogics, in an interview with MD+DI. He explained that there will also be the need to monitor patients with functional impairment and/or hypoxemia after they recover from COVID-19.
To that end, RADLogics has developed an AI-powered system that supports chest imaging for the medical triage of patients...
Source: MDDI - April 14, 2020 Category: Medical Devices Authors: Susan Shepard Tags: COVID-19 Imaging Source Type: news
One Drop ’s Latest Acquisition Takes it Deeper into Telemedicine
Medtech deals are still happening despite the economic pressures brought on by the coronavirus pandemic. The latest deal sees digital health specialist One Drop acquiring all the assets and intellectual property of Sano Intelligence for an undisclosed sum.
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San Francisco, CA-based Sano had developed a biometric sensor that tells a person important things about their health by revealing how the person’s body metabolizes glucose. The deal between the two was structured as an asset purchase with several members of the Sano team slated to join One Drop.
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New York-based One Drop said ...
Source: MDDI - April 14, 2020 Category: Medical Devices Tags: Digital Health COVID-19 Source Type: news
It & #039;s Not Just Diabetes Patients Who Need Glucose Monitoring During This Pandemic
As reported last week, FDA is allowing both Dexcom and Abbott to supply continuous glucose monitoring (CGM) systems for use in the hospital setting during the coronavirus pandemic. This allows frontline healthcare workers in hospitals to remotely monitor patients' glucose levels while minimizing exposure to the virus that causes COVID-19 and preserving use of personal protective equipment.
Dexcom CEO Kevin Sayer said the company had conversations with healthcare providers in Europe about the need for CGM technology for COVID-19 patients and the company started conversations w...
Source: MDDI - April 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Source Type: news
Ventilator Supply Numbers a Very Quickly Moving Target
U. S. Senators Christopher Murphy (D-CT) and Kamala Harris (D-CA) have written to Vice President Mike Pence, demanding information about the quantity of supplies in the Strategic National Stockpile and the process by which those supplies are allocated as the nation fights the COVID-19 pandemic.
"Hospital administrators, mayors, governors, and members of Congress, myself included, have been begging your administration for months to establish a centralized acquisition process," Murphy wrote Pence. "Efforts now must focus critical resources to areas of our country experiencing the greatest increase in COVID-19 cases with the ...
Source: MDDI - April 13, 2020 Category: Medical Devices Authors: Greg Goth Tags: COVID-19 Source Type: news
Several Telemedicine and Remote-Patient Monitoring Solutions Cutting Through the COVID-19 Clutter
(Source: MDDI)
Source: MDDI - April 13, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Digital Health Source Type: news
COVID-19 Business Updates Provide Some Clarity
The unknowns still outnumber the knowns, but recent business updates provide some clarity around how the medical device industry is fairing during the COVID-19 pandemic. First and foremost, it is clear that companies are hurting in the areas of elective procedures, which are being deferred. But there may be some silver linings hidden amongst the bad news.
Needham & Co. medtech analyst Mike Matson estimates that medical device sales across the industry will continue to drop by an average of 40% to 50% until the economy begins to reopen and hospitals start to resume elective procedures.
Matson's e...
Source: MDDI - April 10, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Medtech in a Minute: CGMs Join War on COVID-19, and More
CGMs Join the COVID-19 Fight
In response to healthcare workers asking for safer ways to monitor hospitalized diabetes patients with COVID-19, FDA is allowing both Dexcom and Abbott to supply continuous glucose monitoring (CGM) systems for use in the hospital setting during the pandemic. This allows frontline healthcare workers in hospitals to remotely monitor patients with diabetes in order to minimize exposure to the virus that causes COVID-19 and preserve use of personal protective equipment. Read more about medtech's response to the global pandemic on our COVID-19 News Central page.
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Boston Scientific Recal...
Source: MDDI - April 10, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Source Type: news
