Researchers Say Abbott ’s Antibody Test Demonstrated High Performance in Study
Researchers from the University of Washington said Abbott’s antibody test for the novel coronavirus (COVID-19) performed well in a recent independent study. The research was published in the Journal of Clinical Microbiology.
Researchers evaluated Abbott’s test in three distinct patient populations. In the study, researchers tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the U.S. and found one false positive, indicating a specificity of 99.9%.
The researchers also looked at 125 patients who tested RT-PCR positive for SARS-CoV-2 for which 689 excess serum specime...
Source: MDDI - May 11, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
3D-Printing Manufacturer Nabs EUA to Convert BiPAP Machines into Ventilators
3D printing has emerged as a hero technology during COVID-19 because the technology enables rapid prototyping and production of personal protection equipment (PPE), diagnostic testing swabs, and an array of other medical device components. While there remains limitations with technology, additive manufacturing is far better positioned to respond to urgent supply needs than traditional manufacturing methods.
Case in point, Formlabs recently became the first 3D-printing manufacturer to receive emergency use authorization (EUA) from FDA to print bi-level positive airway pressure (BiPAP) ada...
Source: MDDI - May 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 3-D Printing Source Type: news
Mayo Clinic in Yet Another Collaboration Using AI to Fight COVID-19
Mayo Clinic and Ultromics are employing artificial intelligence to help rapidly assess patients diagnosed with the novel coronavirus (COVID-19).
Under the collaboration, the two will use EchoGo Core, to analyze echocardiograms of COVID-19 victims, to map for the first time how COVID-19 virus attacks the heart with such deadly impact.The multi-site study will look at 500 COVID-19 positive men and women, aged between 18 and 89. These participants will have undergone a clinically indicated echocardiography exam during a three-month period.
The primary objective is the assessment of automated cardiac measurements, ejection fra...
Source: MDDI - May 11, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Digital Health Source Type: news
FDA Authorizes First COVID-19 Test Using Saliva Collected at Home
FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.
To be clear, this isn't the first test the agency has authorized with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers' test previously had been added to FDA's high-complexity molecular-based LDT "umbrella" emergency use authorization to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDN...
Source: MDDI - May 9, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news
Medtech in a Minute: COVID-19 Fraud, a Virtual AFib Trial, and More
FDA Cracks Down on Fraudulent COVID-19 Tests
The agency revised its earlier policy on COVID-19 antibody tests to cut down on false and inappropriate marketing claims that have cropped up. In March it was critical for FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency. But officials said this week that flexibility never meant they would allow fraud.
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Now May Not Be the Best Time for an IPO
Pulmonx was poised to go public but the global pandemic forced the company to switch gears. Still, Pulmonx managed to raise $66 million...
Source: MDDI - May 8, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
How is COVID-19 Going to Change Medtech?
What’s going to happen to the industry after the COVID-19 crisis? Take a look below to see MD+DI's Managing Editor Omar Ford break down his thoughts on the matter. (Source: MDDI)
Source: MDDI - May 7, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Source Type: news
Supplier Stories for the Week of May 3
(Source: MDDI)
Source: MDDI - May 7, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
Grail Raises $390M in Latest Financing Round
Grail, a liquid biopsy specialist, is bringing in $390 million in a series D round.
New investors including the Public Sector Pension Investment Board (PSP Investments) and Canada Pension Plan Investment Board (CPP Investments), as well as two undisclosed investors, joined existing backers including Illumina in this round of funding.
“Grail is making significant progress with our blood-based, multi-cancer early detection test,†Grail CEO Hans Bishop said in a release. “Nearly 80% of cancer deaths result from cancers for which there is no screening test today, and Grail&...
Source: MDDI - May 7, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Business Source Type: news
Anti-Coronavirus Surface Coating Could Be Effective for Months
SARS-CoV-2, the coronavirus that causes COVID-19, has a nasty habit of lingering on surfaces for extended periods of time. For example, active virus particles were found on the Diamond Princess cruise ship 17 days after it had been evacuated. Disinfectants in current use temporarily remove the virus from surfaces such as doorknobs and handrails but don’t protect them from being contaminated anew. Scientists in Israel are engineering novel surface coatings that will have a long-term effect neutralizing the virus, according to a news report. The coatings contain nanoparticles of safe metal ions and polymers...
Source: MDDI - May 7, 2020 Category: Medical Devices Tags: Design News Source Type: news
Fitbit Takes Large-Scale AFib Study Virtual
Fitbit is launching a large-scale virtual study to validate the use of its wearable technology to identify atrial fibrillation in patients. The San Francisco, CA-based company said it plans to enroll hundreds of thousands of people in the Fitbit Heart Study.
Results from the study could help with regulatory submissions.
The company said its wearables have the potential to accelerate AFib detection because their 24/7 heart rate tracking is powered by long battery life, which allows users to wear their device for multiple days at a time.
To track heart rate, Fitbit’s devices use photoplethysmography (PPG) t...
Source: MDDI - May 6, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news
MedAccred Expands Its Reach in Medical Device Manufacturing
MedAccred continues to expand its support for the medical device industry. Described as an “industry-managed supply chain oversight program for critical manufacturing processes,†MedAccred has added new sterile device packaging and plastics mechanical assembly audit processes, added four new subscribers, and accredited many new suppliers within the last year. The program is also entering its second year of partnering with the US Department of Commerce through the Medical Manufacturers MedAccred Accreditation Pathway (MedMMAP) for manufacturers and suppliers seeking accreditation.
Connie ...
Source: MDDI - May 6, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news
Can You Reduce Manufacturing Costs of Drug-Delivery Systems?
Sophisticated devices are being charged with delivering many of today’s novel drug therapies. To ensure patient access to such innovations, pharmaceutical companies and their drug-delivery device partners will need to minimize development and manufacturing costs while still achieving high-quality, advanced solutions.
Mike Kobashi has spent nearly 20 years providing Lean and Six Sigma expertise to multiple manufacturing sites, including those making drug-delivery devices. MD+DI asked Kobashi a few questions about whether lean manufacturing principles could impact the cost of manufacturing drug-delivery dev...
Source: MDDI - May 6, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news
How a Brain-Computer Interface Can Restore the Sense of Touch to a Paralyzed Man
For the first time in 10 years, Ian Burkhart is able to move his arm and feel what he is touching. The findings were reported late last month in the journal Cell.
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Burkhart, who suffered a spinal cord injury (SCI) in 2010 leaving him paralyzed, was the first participant in a five-year study of Battelle's NeuroLife neural bypass technology, a project Battelle has worked on in conjunction with doctors at The Ohio State University Wexner Medical Center. MD+DI previously reported on the study in August 2019, and in April 2016. The latest breakthrough came from analys...
Source: MDDI - May 6, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news
FDA Answers Most Frequent Regulatory Questions about COVID-19 Testing
The weeds of misinformation about COVID-19 are tall and thick, but an update to FDA's frequently-asked questions page should clear some things up, both for test makers and the general public. Because this is such a fluid situation, we have also included the date in parentheses beside each question to indicate when the information was last updated by FDA.
Q: What is the difference between the types of available SARS-CoV-2 tests (May 4)
The term diagnostic test is generally used to refer to molecular or antigen tests, both of which can be used to diagnose infection with the SARS-CoV-2 virus. Molecula...
Source: MDDI - May 6, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Regulatory and Compliance Source Type: news
Pulmonx Delays IPO and Reels in $66M Financing
Pulmonx has raised $66 million in a financing round despite a lull in procedures and a turbulent economy caused by the negative impact of the novel coronavirus [COVID-19].
The commercial-stage medical device firm, which was on the list of 16 Promising Private Medtech Companies in 2019, developed the Zephyr Valve System, a minimally invasive treatment from patients suffering from emphysema.
The financing round comes a little more than a month after Pulmonx delayed its $86 million IPO.
“We were poised to take the company public,†Pulmonx CEO Glen French told MD+DI. “What ...
Source: MDDI - May 5, 2020 Category: Medical Devices Tags: Implants Business Source Type: news
