How Will COVID-19 Impact New Tech?
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There’s no question at this point that the COVID-19 pandemic is going to have a major economic impact on the world. With that comes the question of how new and emerging technologies will be impacted as well. The temptation is to think that everyone will suffer due to supply chain disruptions, work stoppages, and other issues. But that’s not the case across the board.
For some technologies, this pandemic will be more of a growth opportunity than a setback. But which ones?
3D Printing – The Hero’s Journey
An open-source, 3D-p...
Source: MDDI - April 23, 2020 Category: Medical Devices Tags: Design News Source Type: news
Quest Diagnostics Moves Toward Antibody Testing for COVID-19
Quest Diagnostics said it has begun performing antibody testing for COVID-19 using blood samples.
The Secaucus, NJ-based company said its antibody service uses tests developed for high-throughput lab environments. Quest said it is providing the service based on tests from Abbott Laboratories and Euroimmun, a Perkin Elmer company.
In a release, Quest said the Abbott and Euroimmun tests are marked under FDA’s policy for diagnostic tests for Coronavirus Disease-2019. Abbott said it plans to submit for FDA Emergency Use Authorization and Euroimmun is currently seeking EUA.
"As FDA has indicated, antibody test...
Source: MDDI - April 22, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD COVID-19 Source Type: news
Artificial Intelligence and Machine Learning-Based Medical Devices: A Products Liability Perspective
Conclusion
Technological innovation outpaces the law, and artificial intelligence/machine learning is no different. Regardless of how legal doctrines evolve with the introduction of AI/ML-based products, until firm legal and regulatory guidelines progress, one thing is certain: There will be significant disagreement about how products liability law is applied. So, while these products present a new and lucrative market for manufacturers, the drive to supply an ever-increasing market demand must be balanced with a fulsome design, testing, and monitoring process.
References
Mitchell, Tom, Machine Learning Preface XV (1st ed....
Source: MDDI - April 22, 2020 Category: Medical Devices Authors: Matthew Decker Tags: Regulatory and Compliance Source Type: news
FDA Warns of COVID-19 Antibody Testing Limitations
As more antibody tests become available for COVID-19, FDA wants to be sure people – healthcare providers especially – understand that these tests are not intended to diagnose SARS-CoV-2 infection.
The agency issued a letter warning to healthcare providers on Tuesday explaining the limitations of serological testing and why those tests results should not be used as the sole basis to diagnose COVID-19.
Serological tests (also referred to as antibody tests) are designed to detect antibodies present in the blood when the body is responding to a specific infection, suc...
Source: MDDI - April 22, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Regulatory and Compliance Source Type: news
FDA Grants EUA for LabCorp ’s At-Home COVID-19 Test
FDA has granted emergency use authorization LabCorp’s Pixel, an at-home test for the novel coronavirus (COVID-19). In a Tuesday release, the federal agency said this is the authorization of the first diagnostic test with a home collection option for COVID-19.
The Burlington, NC-based company’s Pixel permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.
La...
Source: MDDI - April 21, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Regulatory and Compliance Source Type: news
Medtech Perseveres During COVID-19
The COVID-19 pandemic is “an unprecedented crisis, and we’ve never seen anything like it,†Pat Shafer, managing director in Grant Thornton's healthcare and life sciences industry business, told MD+DI recently.
Judging from the amount of stories MD+DI has published alone in the last several weeks on the rapid responses from many medical device and diagnostics companies as well as industry suppliers, manufacturers are working quickly toward several potential solutions.
The medical device industry has been very agile in responding to the pandemic, Shafer said. â€...
Source: MDDI - April 21, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news
8-Puff Dry-Powder Inhaler Wins Red Dot Product Design Award
Hovione Technology’s 8Shot Dry Powder Inhaler (DPI) has earned the Red Dot 2020 Product Design Award in the Healthcare Daily Living AIDS category.
João Ventura Fernandes, PhD, director of technology development and licensing for Hovione Technology Ltd., told MD+DI that 8Shot “was developed to be the world’s first 8-dose, factory-filled dry powder inhaler device enabling effective and safe drug delivery to the lungs of a range of drugs expected to be developed and reach the market during the next years." It is targeted for "delivery of new pharmaceutical c...
Source: MDDI - April 21, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Design Source Type: news
Conformis Gets Some Economic Relief to Help with Negative COVID-19 Impact
There is a bit of relief for Conformis, a maker of custom orthopedic implants, which has been impacted significantly by the novel coronavirus (COVID-19).
The Billerica, MA-based company said in a release it received $4.7 million under the paycheck protection program (PPP) offered by the U.S. Small Business Administration.
In response to the coronavirus (COVID-19) pandemic, the Coronavirus Aid, Relief, and Economic Security Act authorizes the SBA to make available low-interest rate loans to qualified small businesses under the PPP. According to the terms of the PPP, all or a portion of the loan may be fully forgiven if the ...
Source: MDDI - April 21, 2020 Category: Medical Devices Tags: COVID-19 Business Source Type: news
FemtoDx Working to Develop Rapid At-Home COVID-19 Test
FemtoDx is working to develop a rapid at-home test for the novel coronavirus (COVID-19). On Monday, the Beverly Hills, CA-based company announced its plan to manufacture and distribute the tests directly to patients and providers at a low cost.
The diagnostics company said the consumer test was created using systems from an existing platform and it eliminates the need for a dedicated lab.
“This rapid, at-home test will enable more scalable and efficient testing of COVID-19 that is substantially equivalent to the current gold-standard lab tests,†said Dr. Raj Mohanty, CEO and founder, Fem...
Source: MDDI - April 20, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
Single-Use Bronchoscopes Could Reduce Contamination Risks During COVID-19 Pandemic
In the early days of the current COVID-19 pandemic, samples from biopsies and bronchoalveolar lavage (BAL) fluid were collected via bronchoscopy to isolate the virus and sequence its genome. The Centers for Disease Control and Prevention (CDC) also initially recommended collecting BAL samples for diagnosis.
But after learning more about COVID-19 and how it is transmitted, the American Association for Bronchology and Interventional Pulmonology (AABIP) recently released a guidance that recommends limiting bronchoscopies. “With bronchoscopy, you have the potential to generate aerosols that may be releasing p...
Source: MDDI - April 20, 2020 Category: Medical Devices Authors: Susan Shepard Tags: COVID-19 Source Type: news
Catheter-Based Solution Being Developed to Treat Heart Valve Calcification
Pi-Cardia Ltd. has raised $27 million to develop a catheter-based solution to treat heart valve calcification. The Rehovot, Israel-based company said the financing was led by Sonfinnova Partners and joined by Professor Jacques Séguin, Chairman of the company, with further participation from existing investors.
The financing follows the successful completion of the company’s First-In-Human studies of the Leaflex Catheter.
Pi-Cardia said its technology performs mechanical scoring of valve calcification, restoring leafelts’ mobility and improving valve hemodynamics. The company...
Source: MDDI - April 20, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Business Cardiovascular Source Type: news
Saliva Used to Monitor Glucose Levels?
Can saliva be used to monitor diabetes? Researchers are aiming to find out as they have developed a test that can be used as an alternative to the practice of monitoring blood glucose.
The research was published in the journal PLOS ONE and involved partners at the Federal University of Uberlandia in Minas Gerais, Brazil, the University of Vale do ParaÃba in Sao Paolo, Brazil and the University of Saskatchewan in Canada.
Researchers said the lab tests used a scientific system known as Attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy. This has been used in the diagnosis of several d...
Source: MDDI - April 18, 2020 Category: Medical Devices Authors: MDDI Staff Tags: R & D Source Type: news
Medtech in a Minute: Abbott & #039;s COVID Testing Strategy, Telemedicine, and More
How Abbott Became a Leader for COVID-19 Testing
Abbott tasked four independent R&D teams to develop four different types of testing solutions in response to the COVID-19 pandemic. So far the company has launched three of those tests – a molecular lab test, a rapid point-of-care test, and two different types of antibody tests. Three of those are already on the market and another antibody test is in the pipeline. All four tests have a different value proposition, said CEO Robert Ford.
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Telemedicine Is Here to Stay
Canaccord Genuity's annual survey of medtech executives suggests ...
Source: MDDI - April 17, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news
Can Intuitive Surgical Continue to Rise Above COVID-19 Disruptions?
Intuitive Surgical beat analysts’ estimates and revenue rose about 13% for 1Q20, however, the company said the rest of 2020 is in question because of COVID-19.
The Sunnyvale, CA-based company said procedures with its da Vinci robot were trending at the higher end of expectations during the first two and half months of 1Q20. But the surgical robotics pioneer’s story changed sharply in the latter half of March.
The company said it experienced a decline in procedure volume as healthcare systems in the U.S. and Western Europe diverted resources to meet the increasing demands of managing COVI...
Source: MDDI - April 17, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business COVID-19 Source Type: news
Advancing Medical Device Manufacturing with Factory of the Future Technology
Medical device manufacturers face many of the same challenges that other producers of complex devices and equipment face: controlling costs, maintaining tight inventories and well-coordinated global supply chains, and sustaining flexibility in their production operations so they can change product mix and introduce new products as market requirements change and new opportunities arise.
However, medical device manufacturers also face several challenges unique to their industry:
They produce vital, life-saving products that millions of people depend on for both short-term and long-term care.
Their work and products are highl...
Source: MDDI - April 17, 2020 Category: Medical Devices Authors: Rodney Rusk Tags: Assembly and Automation Source Type: news
