COVID-19, China, and the Tangled Web of Globalized Supply Chains
“Never let a serious crisis go to waste,” Rahm Emanuel famously said about the Great Recession when he served as the White House Chief of Staff under President Obama. “And what I mean by that — it’s an opportunity to do things you think you could not do before,” he added. The sentiment is equally relevant today, as companies reconsider their supply-chain strategies in the wake of COVID-19. That conversation is especially pointed among medical device manufacturers. Image: Denisismagilov/Adobe Stock The severe shortag...
Source: MDDI - May 21, 2020 Category: Medical Devices Tags: Design News Source Type: news

App Puts an Expert in Nurses & #039; Pockets to Reduce Medical Errors
As frontline healthcare workers across the United States continue to treat COVID-19 patients, staff at hospitals that have adopted a mobile app called Elemeno have at least one thing going for them: a coronavirus expert in their pocket. “With this new app, our frontline staff has immediate access to recommended practices to safely care for patients who may have COVID-19,” said Kelly Mather, CEO of Sonoma Valley Hospital,  a UCSF Health affiliate that is now using Elemeno at the recommendation of UCSF. “It has i...
Source: MDDI - May 21, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health COVID-19 Source Type: news

Verily Dives Deeper into COVID-19 with Antibody Testing Research
Verily is hoping to get a deeper understanding of the novel coronavirus (COVID-19) starting with an initial focus of antibody testing. The Alphabet company and former life sciences arm of Google launched the Baseline COVID-19 Research Project. The first tranche of the project will be a serology (or antibody) study offered to individuals in the Bay area that have received COVID-19 nasal swab testing through the Baseline COVID-19 testing program. In an email to MD+DI, a spokesperson for the company wrote, “Verily recently launched the Baseline COVID-19 Research Project to advance the scientific understandin...
Source: MDDI - May 20, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 R & Source Type: news

NFL Explores Modified Face Masks for Player Helmets
NFL players could be sporting helmets with full-cover face masks unlike anything fans have ever seen before in the upcoming season. Thom Mayer, medical director for the NFL Players Association, told ESPN's Adam Shefter that NFL engineers and Oakley are working together to develop new face masks in an effort to protect players from the coronavirus. Mayer said it is a possibility that the face mask could be modified to include surgical or N95 material, even quipping that if it works he wants them to be called "Mayer Masks." He doesn't know yet just what the modified masks will look like, however. "They've got som...
Source: MDDI - May 20, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 R & Source Type: news

Tackling Infection Control in CT Exams Areas During a Pandemic
A team of radiologists from China discussed making changes to the CT examination process during the novel coronavirus (COVID-19) pandemic. The group’s work was published in an open-access article published ahead-of-print by the American Journal of Roentgenology (AJR). Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital researchers noted, to undergo CT, patients must exit the fever clinic and proceed to an examination room elsewhere at the institution. The team said that moreover, CT examination rooms are not designed according to the rule of three zones and two aisles - clean zone, sem...
Source: MDDI - May 20, 2020 Category: Medical Devices Authors: MD+DI Staff Tags: R & D Imaging Source Type: news

FDA Partners with Aetion to Answer Urgent COVID-19 Research Questions
If it takes a village to raise a child, it takes an entire world to defeat a pandemic. That sentiment is becoming more evident every day as we see cross-industry collaborations and public-private partnerships evolving to combat COVID-19. Take, for example, a new agreement between FDA and Aetion, a venture-backed healthcare data analytics company based in New York, NY. The partnership aims to assess real-world data sets to generate clinical insights about the course and treatment of the novel coronavirus. "We believe that this work has the potential to contribute to the scientific evaluation of poten...
Source: MDDI - May 19, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Software Source Type: news

3 Roche Companies Hope to Make Clinical Trials More Efficient
Three companies under the Roche umbrella are looking to shake up the way clinical trials are conducted and better understand the patient journey during these studies. To this end, Flatiron Health, Foundation Medicine, and Genentech have launched the Prospective Clinico-Genomic (PCG) feasibility study. The trial will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline, and simplify the execution of clinical trials for patients living with advanced lung cancer. About 1,000 patients will be enrolled in PCG, which has a secondary aim to better understand how genomic changes in a...
Source: MDDI - May 19, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business IVD Source Type: news

Beware of Filtering Face Respirators Made in China
Certain respirators made in China may not provide consistent and adequate respiratory protection to healthcare workers exposed to COVID-19, FDA said after a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95% in testing. The testing was conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory of the Centers for Disease Control and Prevention. Based on the NIOSH testing, FDA revised and reissued its earlier emergency use authorization (EUA) for non-NIOSH-approved dis...
Source: MDDI - May 19, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Regulatory and Compliance Source Type: news

Edwards Makes Gains in Tricuspid Regurgitation Repair with CE Mark
The Irvine, CA-based company said the Pascal repair system demonstrated high procedural success and significant clinical improvements in patients with challenging tricuspid anatomy and severe TR. Sustained TR reduction was observed at 30 days, with 85% of patients seeing a reduction to TR ≤2+ on a five-grade scale. "Patients with tricuspid valve disease are in great need of solutions," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "Edwards is the first company to introduce multiple transfemoral tricuspid repair therapies in Europe, providing ...
Source: MDDI - May 18, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Microsoft and UnitedHealth Launch App that Screens for COVID-19 Symptoms
Microsoft and UnitedHealth Group have joined forces to support return-to-workplace planning, as the push to reopen the economy continues in the U.S. To do this, the two companies are launching the ProtectWell protocol, which includes a smartphone app that can help screen for COVID-19 symptoms. A breakdown of the app shows it includes an AI-powered healthcare bot that asks users a series of questions to screen for COVID-19 symptoms or exposure. If risk of infection is indicated, employers can direct their employees to a streamlined COVID-19 testing process that enables closed-loop ordering and reporting of test results dire...
Source: MDDI - May 18, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Medtech in a Minute: Abbott Gets Defensive, Breast Implant Makers Land in Hot Water, and More
Abbott Defends Its Rapid COVID-19 Test FDA alerted the public on Thursday that early data from independent studies suggests potential inaccurate results from using the Abbott ID NOW point-of-care diagnostic for COVID-19. The agency has also received 15 adverse event reports about the ID NOW test that suggests some users are receiving inaccurate negative results. Abbott went on the defensive and pointed out that test outcomes depend on a number of factors, including conformity to the way the test was designed to be run. Some researchers, for example, reported transporting the samples to a central lab and running the test an...
Source: MDDI - May 16, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news

The Number of COVID-19 Tests Keeps Growing with New Hologic Diagnostic
FDA is still granting Emergency Use Authorization (EUA) for COVID-19 tests, even though the conversation surrounding is shifting to antibody testing. This time Hologic has received EUA for the Aptima SARS-CoV-2 test. The Marlborough, MA-based company received authorization for a COVID-19 detection tool in March. The Aptima SARS-CoV-2 test runs on Hologic’s Panther system. The company said each Panther system can provide initial results in about three hours and process more than 1,000 coronavirus tests in 24 hours. The test is being distributed and Hologic said it expects to produce an average of one mill...
Source: MDDI - May 15, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news

The Medical Device Industry Needs Risk Management in the New Normal
Amid the current COVID-19 pandemic, many medical device manufacturers and suppliers are moving at unprecedented speeds to develop and enact updated risk management policies and procedures. Much of what they are developing are plans to help manage manufacturing and supply-chain challenges in times of crisis. As evidenced throughout this pandemic, these policies and procedures are critical to preventing severe shortages of essential items to patients and healthcare workers. As doctors continue to investigate multiple strains of the virus, the circumstances surrounding COVID-19 seem to change as quickly as it is transmitted. ...
Source: MDDI - May 15, 2020 Category: Medical Devices Authors: Michael Kolias Tags: Business Source Type: news

Breast Implant Makers Land in Hot Water with FDA
FDA took action Thursday that proves the agency is still keeping close tabs on the breast implant market, which has long been plagued with safety and regulatory problems. FDA sent warning letters this week to Allergan and Ideal Implant failure to comply with various regulatory requirements. In Allergan's case, the Irvine, CA-based company has allegedly failed to comply with post-approval study requirements to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. In Ideal Implant's case, the Dallas, TX-based company allegedly fa...
Source: MDDI - May 15, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Implants Source Type: news

Abbott Defends the Accuracy of Its Rapid COVID-19 Test
This micro-podcast episode gives you the details you need most on this developing story. Scroll down to read the full story.   What's going on? Several independent research teams have called into question the accuracy of Abbott's ID NOW COVID-19 test, a rapid point-of-care molecular diagnostic test designed to produce results in five minutes. FDA granted Abbott an emergency use authorization of the test in late March. The accuracy of the test was first questioned by researchers at NYU Langone Health. The NYU researchers conducted a study involving 101 patients receiving emergency COVID-19 care through the syst...
Source: MDDI - May 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news