Abbott Defends Rapid COVID-19 Test after NYU Researchers Questioned the Accuracy
This micro-podcast episode gives you the details you need most on this developing story. MD+DI will publish a full story on the issue shortly. (Source: MDDI)
Source: MDDI - May 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news
Procedure Recovery May Be Slower than Expected, Survey Says
A consumer survey conducted by analysts at Needham & Co. sheds some light onto what the procedure recovery could look like in the United States as hospitals in many states have begun resuming elective procedures.
"The results of the survey indicate that consumers remain hesitant about elective procedures with 26% indicating that they don't feel comfortable having an elective procedure until 2021 or later," said Mike Matson, a medtech analyst at Needham & Co.
The firm surveyed 269 consumers across the United States on May 11 and May 12, however the analysts noted that the number of responses varied for e...
Source: MDDI - May 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business COVID-19 Source Type: news
Supplier Stories for the Week of May 10
(Source: MDDI)
Source: MDDI - May 14, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
PPE Industry Experiences Turbulence in Wake of COVID-19
If you’re not a healthcare provider or a worker exposed to hazardous conditions, chances are you didn’t pay much attention to personal protective equipment (PPE). That all changed with COVID-19. Frost & Sullivan recently hosted a webinar on the almost $60-billion PPE industry, highlighting how the outbreak has changed the business going forward. As always, there will be winners and losers within this industry that includes such major players as 3M, DuPont, Honeywell, Moldex, and Cardinal Health. Sanjiv Bhaskar, Vice President, Global PPE Practice, offered his informed perspectives. H...
Source: MDDI - May 14, 2020 Category: Medical Devices Tags: Design News Source Type: news
Advanced Thermal Imaging May Help Get More People Back to Work
Not all companies are rushing to bring back employees as the country reopens for physically distanced business. Coca-Cola, headquartered in Atlanta, will keep workers home, despite loosened restrictions in Georgia. Most of Morgan Stanley’s employees, spread across the United States, will continue working remotely.
What will it take for people to return to work on a grander scale? Generally, state governments want to see flattened and decreasing infection rates, an increase in COVID-19 testing and contact tracing, and adequate hospital beds and PPE. As states move closer to their testing, tracing, and PPE ...
Source: MDDI - May 14, 2020 Category: Medical Devices Authors: Heather R. Johnson Tags: Software Source Type: news
CardioFocus Wins FDA Nod for NextGen AFIb Treatment
CardioFocus has won a nod from FDA for the next-generation HeartLight X3 Endoscopic Ablation System. The Marlborough, MA-based company said the device is used in the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAFib).
The company received CE mark for the technology in March of 2019. HeartLight X3 is a third-generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib.
The approval of the sys...
Source: MDDI - May 13, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Cardiovascular Source Type: news
Has COVID-19 Created a Tipping Point in the MedTech Industry?
The coronavirus pandemic has been one of the greatest tests for the MedTech industry in modern time. The global effects have left many industries reeling and asking questions about how their business can react in times of crisis. For medical device manufacturers, this event could be a tipping point to embrace digitalization and Industry 4.0 (I4.0) production technologies.
“Clinical Diagnostic, Medical Device companies are committing significant resources to support the fight against COVID-19. However, many of these organizations are facing challenges managing their business in this new virtual and remote ...
Source: MDDI - May 13, 2020 Category: Medical Devices Source Type: news
Thermo Fisher Enlists WuXi and Mayo Clinic for New Serology Test
Thermo Fisher Scientific is continuing to move fast and furious with its COVID-19 detection efforts. The firm is now collaborating with WuXi Diagnostics and Mayo Clinic to develop a new serology test in response to the COVID-19 pandemic.
Plans call for Waltham, MA-based Thermo Fisher to seek FDA Emergency Use Authorization (EUA) and international regulatory authorizations for the OmniPath COVID-19 Total Antibody Elisa test in the coming weeks.
Thermo Fisher said once approved for use, the OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine i...
Source: MDDI - May 13, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
Preparing for the EU Medical Device Regulation
The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to delay was made in response to the COVID-19 outbreak’s impact on manufacturers, notified bodies, suppliers, research institutions, and other parties, with patient health and safety as a guiding principle. Though this delay would give businesses an extra year, it will be challenging for some businesses to prepare in the context of the pandemic. (The proposal does need to be approved by EU member states and published in the...
Source: MDDI - May 13, 2020 Category: Medical Devices Authors: Ramya Sriram Tags: Regulatory and Compliance Source Type: news
Share Your Ideas for Medtech Engineering and Regulatory Success at MD & amp;M West 2021
The call for speakers for the 2021 MD&M West Conference is now open. R&D, design, product development, and process and quality engineers are encouraged to share their innovation strategies and tactics to move medtech forward! Apply today to speak at the 2021 MD&M West Conference to be held February 9-11, 2021, at the Anaheim Convention Center. The deadline to apply is July 31, 2020.
We’re looking for R&D, design and front-end product development engineers working for finished medical device manufacturers to speak, lead panels, or host roundtable discussions. We’d love to ...
Source: MDDI - May 13, 2020 Category: Medical Devices Authors: Laurie Lehmann Tags: Regulatory and Compliance Source Type: news
What Are Medtech CEOs Saying about COVID-19?
(Source: MDDI)
Source: MDDI - May 12, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Antiviral and Antimicrobial Additive Developed for Face Masks, Medical Apparel
The emergence of the SARS CoV-2 virus, which causes COVID-19, has brought to the forefront another beneficial aspect of plastics — antimicrobial and antiviral additives that can help protect humans. Tosaf, a member of the Ravago Group, announced that it has developed an antimicrobial, antiviral additive for polyolefin nonwoven fabrics and films. The new additive will be used in the production of disposable face masks, protective apparel, and similar medical products.
While it is recommended that many people, including healthcare workers and those vulnerable to the virus, wear face masks, the coverings do...
Source: MDDI - May 12, 2020 Category: Medical Devices Tags: Design News Source Type: news
Ortho Clinical Diagnostics Brings in CE Mark for Antibody Test
Ortho Clinical Diagnostics has received CE mark for its COVID-19 total antibody test. The CE mark comes just a few weeks after the Raritan, NJ-based company was granted an emergency use authorization by FDA for the test.
The company said the test detects all COVID-19 related antibodies (IgA, IgM and IgG), including IgM, which appears in the early, acute stage of infection, and helps determine the onset of a patient's immune response by monitoring all antibodies generated through disease progression.
The firm said the test can help health care professionals understand if a patient has been exposed to and has developed antib...
Source: MDDI - May 12, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
Medical Device Service Businesses —Is Cash King Today or Is Survival?
Spoken by the late and well-respected business leader Jack Welch, “Cash is King†is a mantra many business leaders live by, but what does that mean today in the midst of COVID-19? Think of the thousands of service businesses that had their business strategies laid out and their 2020 plans unveiled to associates and leaders. Then, only a month and a half into the year, they had to suddenly pivot from executing their strategy to placing it on hold and moving into a reactionary tactical mode.
Though service businesses across many industries have been impacted by COVID-19, the medical device...
Source: MDDI - May 12, 2020 Category: Medical Devices Authors: Shawn LaRocco Tags: Business Source Type: news
Forward-Looking Statement Disclosures Have Never Been More Important for Medtech Companies
Executives at public medtech companies won't soon forget the current earnings season. At a time of year when companies typically offer investors insight regarding annual revenue projections, the global pandemic has made such forecasting all but impossible to do.
A lot of medtech companies – including Boston Scientific, Zimmer Biomet, NuVasive, and Endologix – have opted to withdraw revenue guidance this year, while other companies have tried to adjust their earnings forecast as conservatively as possible based on current knowledge and expectations. Unfortunately, this may be a "damned if...
Source: MDDI - May 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Regulatory and Compliance Source Type: news
