App Predicts Blood Glucose Levels 60 Minutes into the Future
There's a new, AI-powered diabetes app that claims to accurately predict blood glucose levels sooner than the industry-leading continuous glucose monitoring (CGM) systems, which currently tout 20-minute glucose value prediction capabilities. Bio Conscious Technologies said an in-house silico study of its Diabits AI algorithm demonstrated its ability to provide 60-minute blood glucose value predictions. The Vancouver, British Columbia-based company says the app is designed for people with diabetes who use a CGM to monitor their daily blood sugar fluctuations. “The ability to accurately predict ...
Source: MDDI - June 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

RapidAI is Set to Acquire EndoVantage for an Undisclosed Sum
M&A is still a thing during the COVID-19 Pandemic. Advanced stroke imaging firm, RapidAI is acquiring EndoVantage, developer of the Find, Track, and Treat comprehensive cerebral aneurysm management platform. Menlo Park, CA-based RapidAI said this acquisition can help it expand its scope, from ischemic stroke to hemorrhagic stroke and now aneurysm. EndoVantage was started at Mayo Clinic and Arizona State University has developed a powerful award-winning computational platform that provides comprehensive cerebral aneurysm management, automating the entire workflow from initial assessment, growth monitoring, to treatment ...
Source: MDDI - June 10, 2020 Category: Medical Devices Tags: Business Cardiovascular Source Type: news

DoD Funds Clinical Trial of Seraph Blood Filter to Treat COVID-19
The Department of Defense is funding a clinical trial of a COVID-19 treatment using ExThera Medical’s Seraph 100 Blood filter. The device was selected to be in the multi-center randomized clinical trial because it showed encouraging preliminary results in critically ill COVID-19 patients at a military hospital in the U.S. and 14 other hospitals in Europe. Investigators at the Uniformed Services University in Bethesda will run the trial of the Martinez, CA-based company’s device. Initial reports indicate Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with ...
Source: MDDI - June 10, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Business Source Type: news

Study Could Add More Depth to Bioelectronic Medicine
This study is one of several that we’re conducting and there are more coming out in the next few months,” he said. “I see this study and [the upcoming studies] as part of this big story that has to do with building the second generation vagus nerve stimulation therapies – that will be much more effective and much safer. It will allow a lot of flexibility to healthcare providers in individualizing the therapy to specific subjects.” (Source: MDDI)
Source: MDDI - June 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health R & Source Type: news

Devices Will Play A Greater Role in COVID-19
Up until now, medical devices have been in the background when it comes to the novel coronavirus. The bigger stories in the industry came from diagnostic firms either developing virus detection or antibody tests.   However, that all changed when Danvers, MA-based Abiomed was granted Emergency Use Authorization for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism.   I give my take on why this lone EUA could be the start of more device-related solutions regarding symptoms associated with COVID-19.   &Acir...
Source: MDDI - June 8, 2020 Category: Medical Devices Tags: COVID-19 Source Type: news

Procedure Volumes Are Rebounding Faster than Expected —but Still Far from Normal
From a revenue perspective, the biggest hit on the medical device industry during the height of the global coronavirus pandemic was the fact that most non-emergency procedures were deferred. This was necessary both as a safety precaution for patients and to conserve hospital resources for COVID-19 patients. The good news, however, is that analysts are seeing positive signs of procedure volume recovery, particularly in orthopedics, which was by far the hardest hit sector. In a recent survey of 51 orthopedic practices, Canaccord Genuity analyst Kyle Rose measured the rates of patient volumes since the...
Source: MDDI - June 8, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Orthopedics Source Type: news

Medtronic Expands Indications for the Resolute Onyx DES in Europe
Medtronic has scored CE mark for a unique indication for the Resolute Onyx drug-eluting stent. The Dublin-based company said the approval was for a DAPT indication for high bleeding risk (HBR) patients. The firm said for HBR patients whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx. The indication is based on results from the Onyx ONE Global Study, a prospective, randomized, one-month DAPT...
Source: MDDI - June 8, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Cardiovascular Source Type: news

Medtech in a Minute: Bigfoot Steps Up the Funding Game, Fitbit Flow, and More
Fitbit Dives Deeper Into Medtech with Ventilator FDA granted an emergency use authorization for the Fitbit Flow, a low-cost ventilator, for use during the COVID-19 pandemic. The company said the device builds on standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and patient monitoring.   Advamed Takes a Stand Against Racial Injustice It's rare that the head of one of the industry's most prominent trade associations takes a stand on a controversial social issue, but as the father of a blac...
Source: MDDI - June 8, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Digital Health Source Type: news

Abiomed Granted IDE to Evaluate ‘World’s Smallest Heart Pump’
Abiomed said it has received approval for an IDE to start an early feasibility study of what it is calling the “world’s smallest heart pump.”   The Danvers, MA-based company said the first-in-human trial will look at the 9 French Impella ECP heart pump in high-risk percutaneous coronary intervention (PCI) patients.   The primary endpoint of the study is successful delivery, initiation, and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI.   The stu...
Source: MDDI - June 6, 2020 Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news

Supplier Stories for the Week of May 31
(Source: MDDI)
Source: MDDI - June 5, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Assembly and Automation Source Type: news

Fitbit Continues its Race into Medtech with New EUA
Fitbit is continuing its rapid trajectory into the medtech industry with a new Emergency Use Authorization from FDA. The San Francisco, CA-based company said the EUA is for a low-cost emergency ventilator to help address patients’ needs during the COVID-19 pandemic. The company said after seeing the need for ventilators, it applied its deep in-house expertise in advanced sensor development and hardware design to quickly create Fitbit Flow, an automatic resuscitator inspired by the MIT E-Vent Design Toolbox and based on specifications for Rapidly Manufactured Ventilation Systems. Fitbit said during develop...
Source: MDDI - June 5, 2020 Category: Medical Devices Tags: COVID-19 Business Source Type: news

How Ready Are You for the Next Crisis?
During the COVID-19 pandemic, medical device and diagnostics companies and their partners have been responding with rapid solutions to meet urgent healthcare needs. Much has been learned from the quick response that could help the medical device industry prepare for future pandemics, disasters, and other potential supply-chain disruptions. MD+DI will be exploring such lessons in the webinar series, How the Medtech Industry Can Respond to Crisis. The six individual webinars held the week of June 22 include: June 23, 11 am EDT: Respond and Restore: Best Practices for Responding to a Pandemic (and Other Crises) June 23, 2 pm ...
Source: MDDI - June 4, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

AdvaMed CEO: We Can and Must Stand for the Cause of Equal Justice for All
As a journalist covering the medical device industry for more than a decade, I cannot recall the last time AdvaMed took a stand on a controversial social or political issue. The trade association is known for advocating on a range of policy issues impacting the industry but tends to avoid the really hot-button topics such as gun violence and police brutality. Until now. "For too many in this country, the fear of a similar fate [to that of George Floyd] has led to outrage, anger, and hopelessness. We are seeing this expressed in cities across the nation, and for good reason. We are proud of our ...
Source: MDDI - June 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

LaunchPad Lands Coveted Grant for Dental Bone Graft
In more than 30% of dental implant cases, existing bone graft materials fail to achieve the desired clinical results, and another bone graft procedure must be conducted, increasing the overall time and cost of the treatment. That's where LaunchPad Medical could potentially change the game with its new dental bone graft solution based on the company's Tetranite technology. The Lowell, MA-based company won a $1.8 million grant from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center to initiate a pivotal animal study of its technology. The grant was funded by the National Institutes of Health's Nat...
Source: MDDI - June 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Implants Source Type: news

Bigfoot Takes a Big Step Closer to Market with $55M Financing
Bigfoot Biomedical hasn't let the coronavirus pandemic stand in the way of bringing its injection-based digitized insulin dosing platform to the U.S. market. If anything, CEO Jeffrey Brewer says the pandemic has "only crystalized the need for medical solutions like ours that facilitate remote care, remote support, and home delivery." The company has raised a total of $55 million to close its series C equity financing. Abbott led the round with support from existing investors, including Quadrant Capital Advisors, Senvest Capital, Janus Henderson, and Cormorant Asset Management, along with n...
Source: MDDI - June 3, 2020 Category: Medical Devices Tags: Business R & D Source Type: news

Fractyl Seeks to Turn Diabetes On Its Ear with Revita DMR
Fractyl Laboratories is seeking to ‘turn back the clock’ in Type 2 diabetes progression with its disease-modifying therapy. FDA granted the Lexington, MA-based company IDE to launch a pivotal trial of the Revita DMR, a which holds the potential to eliminate the need for insulin injections in patients suffering from Type 2 diabetes. “Insulin is a challenging drug for patients with Type 2 diabetes because it can cause weight gain,” Harith Rajagopalan M.D. Ph.D., co-founder and CEO of Fractyl told MD+DI. “It can cause a risk of your bloo...
Source: MDDI - June 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Implants Regulatory and Compliance Source Type: news

Medical Device Developers to the Rescue
Conclusion Medical device specialists want to help, but responding to pandemic shortages can be complicated. These takeaways come from our experience with building PPE, but they apply to any collaborative rapid response project. Use these tips as a framework to get you and your team on the path to meaningful progress. (Source: MDDI)
Source: MDDI - June 3, 2020 Category: Medical Devices Authors: Scott Thielman Tags: Design Source Type: news

Open-Source Release Allows Manufacturers Worldwide to Produce the UMN & #039;s Low-Cost Ventilator
There has been no shortage of innovation and collaboration across the industry to provide critical medical solutions in response to the coronavirus pandemic, but developing a much-needed device is only half the battle. To truly make an impact, innovators need to make their technology available to as many patients as possible. With that end-goal in mind, some organizations are open-sourcing their designs in an effort to ramp up production and distribution. The latest example of this trend comes out of the University of Minnesota (UMN) Bakken Medical Device Center. In early April, MD+DI reported that ...
Source: MDDI - June 3, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Contract Manufacturing Source Type: news

Dear Dentists, Spare Us the Bloody Pictures, Please
Traditionally, dentists (and other medical professionals, for that matter) didn't have to worry about a social media presence. Times have changed, however, and a recent DentaVox survey suggests that dentists who engage with patients on social media are perceived as more innovative and caring than their "traditionalists" counterparts. Not all content is suitable to share, however and, for most patients, images from bloody procedures are a hard pass. While 97% of respondents say they favor the use of social media by dental specialists, with Facebook being considered t...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Business Source Type: news

Consider the Promises and Challenges of Medical Image Analyses Using Machine Learning
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Artifical intelligence (AI) has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly and offering providers and patients with life-changing insights into a variety of diseases, injuries, and conditions that may be hard to detect without the supplemental technology. Images are the largest source...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Partha S. Anbil and Michael T. Ricci Tags: Imaging Source Type: news

New EUA Places Abiomed Firmly in the COVID-19 Conversation
Sometimes when the discussion of tackling the novel coronavirus comes up, the use of medical devices gets lost in the shuffle. Most of the conversation surrounding COVID-19 comes from either the promise of a vaccine or the expansion of tests. Abiomed is adding to the conversation surrounding medtech’s potential contribution to the treatment of COVID-19 patients. Monday, the Danvers, MA-based company by receiving Emergency Use Authorization for a device to treat COVID-19 related right heart failure patients. The Impella RP is a temporary heart pump that provides circulatory support for patients who develop...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular COVID-19 Source Type: news

Pool of Antibody Tests Continues to Grow
The number of antibody tests for COVID-19 issued emergency use authorization continues to swell. Siemens Healthineers adds to that numbers as it said it has been issued EUA from FDA for an antibody test to detect the presence of SARS-CoV-2. The Erlangen, Germany-based company said the test data demonstrated 100% sensitivity and 99.8% specificity. Tests with a high level of specificity yield low false-positive rates, which is highly desirable especially when prevalence of disease is low. The total antibody test SARS-CoV-2 Total (COV2T)is available on the largest installed base of high-throughput analyzers, including the Ate...
Source: MDDI - June 1, 2020 Category: Medical Devices Tags: COVID-19 IVD Source Type: news

Strategic National Stockpile Legislation May Not Address the Real Problem
In the wake of widely reported shortfalls and unexplained re-routing of material in the Strategic National Stockpile (SNS) throughout the most critical stages of the COVID-19 pandemic, Congressional Democrats wasted no time introducing legislation that would mandate better and more transparent management of the resource. That effort, however, may be an example of inventorying trees without recognizing the entire forest is sparsely grown out, according to one expert on the medical supply chain. “There’s a lot of misunderstanding about the stockpile, and people are using the stockpile as a...
Source: MDDI - June 1, 2020 Category: Medical Devices Authors: Greg Goth Tags: Regulatory and Compliance Source Type: news

Medtech in a Minute: Philips Regulatory Win, Eko ’s Telemedicine Play, and More
Philips Wins Regulatory Nod for Clinical Surveillance Biosensor Philips won a nod from FDA and a CE mark for a next-generation wireless wearable biosensor to help monitor COVID-19 patients in hospital. The Amsterdam, Netherlands-based company touts its next-generation device as being able to enhance clinical surveillance in its patient deterioration detection solution to help clinicians detect risk so they can intervene earlier and help improve care in lower acuity care areas.   Eko Moves Deeper into Telemedicine in the Age of Social Distancing The digital health company is launching a platform that will combin...
Source: MDDI - May 30, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Quest Wins EUA for COVID-19 Self-Collection Kit
Quest Diagnostics has won emergency use authorization for a self-collection kit for COVID-19. The Secaucus, NJ-based company said its test is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. The self-collection kit allows an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature (without a frozen cold pack). Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test...
Source: MDDI - May 29, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news

Medtronic Issues Recall for HVAD Pump Outflow Graft
Medtronic is recalling its HeartWare HVAD pump outflow graft and outflow graft strain relief because of the risk of breaks and tears during the pre-implant pump assembly process. FDA has identified this as a Class I recall. The Dublin-based company said it has received 92 complaints. The recalled products according to FDA’s release are: HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Model Numbers:HVAD Pump Outflow Graft: 1125 HVAD Pump Implant Kit: 1103 HVAD Implant Accessories Kit: 1153 Distribution Dates: March 1, 2018 to April 1, 2020   Medtronic said the use of the affe...
Source: MDDI - May 29, 2020 Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news

InspectIR Systems Launches Trial for Mobile Device to Detect COVID-19
InspectIR Systems has launched a clinical trial focused on using a mobile device for the detection of the novel coronavirus (COVID-19). The Frisco, TX-based company began the trial on Wednesday and said it will test the InspectIR portable breathalyzer. "As most of us have experienced, the world has changed due to the coronavirus pandemic. We challenged our development teams with a simple question: 'Can we help?' We quickly realized our devices could identify COVID-19 in the breath and help with the unique circumstances facing the U.S. and the world right now," InspectIR CEO Tim Wing, said in a release. "It p...
Source: MDDI - May 29, 2020 Category: Medical Devices Authors: MDDI Staff Tags: COVID-19 IVD Source Type: news

Supplier Stories for the Week of May 24
(Source: MDDI)
Source: MDDI - May 28, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news

Eko Moves Deeper into Telemedicine in the Age of Social Distancing
Physicians and clinicians are facing the unique challenge of practicing social distancing with their patients during the COVID-19 pandemic. It seems almost impossible because the practice of healthcare is so hands-on. However, Eko Health is hoping to overcome this challenge by marrying its technology with telemedicine. Last week, the digital health company launched Eko Telehealth, an artificial intelligence-powered telemedicine platform geared toward cardiac exams. “As we think of the future of healthcare, the fact the clinician and the patient aren’t in the same room shouldnâ€...
Source: MDDI - May 28, 2020 Category: Medical Devices Tags: COVID-19 Digital Health Source Type: news

The New Normal of Workplace Safety
Just a couple of short months ago, workplace safety was a familiar concept. The potential hazards — exposure to chemicals, proximity to machinery, ladders, and so forth — and the preventive measures implemented by employers were straightforward and well-understood. What does that look like in the COVID-19 era? Social distancing . . . temperature checks . . . obsessive hand washing . . . face masks and shields . . . double and triple shifts to comply with strict capacity requirements. And that bulletin board where the company proudly touted the number of days without a workplace injury? N...
Source: MDDI - May 28, 2020 Category: Medical Devices Tags: Business Source Type: news

16 Medtech Companies with Innovations Centered Around COVID-19
(Source: MDDI)
Source: MDDI - May 28, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news

Advanced Technology for Plastics Staking and Swaging
Plastic swaging and staking technology is favored for many types of plastic-based assemblies because by forming a plastic post or flap, it is possible to securely connect or “capture” components made of a diverse range of materials—not just plastics, but metals, fabrics, filter media, and even PCBs, switches, and electronics. Permanent and strong thermoplastic stakes or swages can be made quickly and at relatively low cost, without the need for processes involving labor-intensive mechanical fastening or expensive adhesive-fastening processes. Typical processes include: ...
Source: MDDI - May 27, 2020 Category: Medical Devices Authors: Priyank Kishor Tags: Assembly and Automation Source Type: news

5G Doesn ’t Cause COVID-19! Here & #039;s Everything You Need to Debunk the Myth
(Image source: WHO) There are two key differences between the novel coronavirus that causes COVID-19 and 5G technology. One has spread across the globe, the other has barely rolled out in most countries and in some cases not at all. That hasn’t stopped conspiracy theorists from conflating the two however. Thanks to a combination of scam artists, the reach of social media, ignorant celebrities and influencers, and general public frustration and confusion, a strange theory has emerged in the months since the global COVID-19 pandemic started. Allegedly, 5G is the culprit behind the pandemic. Citing a lot of ...
Source: MDDI - May 27, 2020 Category: Medical Devices Tags: Design News Source Type: news

Philips Wins Regulatory Nod for Clinical Surveillance Biosensor
Philips has won a nod from FDA and a CE mark for a next-generation wireless wearable biosensor to help monitor COVID-19 patients in hospital. The Amsterdam, Netherlands-based company touts its next-generation device as being able to enhance clinical surveillance in its patient deterioration detection solution to help clinicians detect risk so they can intervene earlier and help improve care in lower acuity care areas. The Philips Biosensor BX100 is designed to address a new approach to vital signs measurements, supporting surveillance of higher acuity patients moving from intensive care units into lower acuity general care...
Source: MDDI - May 27, 2020 Category: Medical Devices Authors: MDDI Staff Tags: COVID-19 Source Type: news

Will Emerging Contact Tracing Solutions Be Put to Work?
Resolve to Save Lives, an initiative launched by global health organization Vital Strategies, released a playbook that describes four essential actions governments need to take to reopen society quickly and safely in the midst of the COVID-19 pandemic: Test widely—> Isolate infected people—> Find people who have been in contact with infected people—> Ask those people to quarantine for 14 days. Step three—contact tracing—is crucial for controlling spread of the novel coronavirus and for understanding how it spreads. While tech...
Source: MDDI - May 26, 2020 Category: Medical Devices Authors: Heather R. Johnson Tags: Digital Health Source Type: news

Bardy Expands Home Enrollment Program for Cardiac Patch Monitor
Bardy Diagnostics is expanding the home enrollment program for its cardiac patch monitor and won CE mark for a 14-day version of the device. The Seattle, WA-based company said it was exploring more telehealth opportunities with Carnation Ambulatory Monitor (CAM) patch because of the rapidly evolving COVID-19 public health emergency. Typically, the CAM patch is applied to a patient in the clinic setting. In a prepared statement Ken Nelson, chief commercial officer of Bardy Diagnostics said, “To help address the evolving needs of physicians and patients in this public health emergency, facilitat...
Source: MDDI - May 26, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Cardiovascular Source Type: news

How Can Early-Stage Medical Device Companies Survive Market Turmoil?
The coronavirus pandemic has caused market turmoil that has had a negative impact on medical device companies of all sizes. While the large, established medical device players like Medtronic have the balance sheets and product pipelines to  emerge from the pandemic stronger than ever, the real concern is in how younger companies will survive. The secret may lie in a business model that's more often found in the biopharma world than in medtech. "What we're doing at Orchestra BioMed is applying what have been fairly long-established and proven business strategies from the biopharma si...
Source: MDDI - May 24, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business COVID-19 Source Type: news

Medtech in a Minute: Contact Tracing, NFL Face Masks, and More
Google and Apple Launch Highly Anticipated Contact Tracing Technology The two tech rivals have developed the Exposure Notification technology which can inform someone if they may have come in contact with a person that was diagnosed with COVID-19. The move comes as more tech companies are stepping up to help in the fight against the pandemic. The Exposure Notification has the specific goal of rapid notification, which is especially important to slow the spread of the disease with a virus that can be spread asymptomatically. NFL Explores Modified Face Masks for Player Helmets The medical director for the NFL Players Associa...
Source: MDDI - May 23, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Digital Health Source Type: news

Will Medtronic Emerge from the Pandemic Even Stronger?
As MD+DI reported in April, Medtronic was already bracing for its fiscal fourth quarter to reflect significant revenue declines, thanks to COVID-19.  But CEO Geoff Martha said the company is focused on emerging from this pandemic even stronger. He even hinted that we could see more tuck-in acquisitions going forward, as the current environment does make it a good time for M&A. Given the progression of COVID-19 around the world and the timing of the company’s fiscal quarter, Medtronic’s fourth quarter includes an additional month of impact compared to companies...
Source: MDDI - May 22, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news

Remaining Competitive in the Medtech Industry
Within the healthcare industry there is an understanding among medical device companies that the drive for improvements in both manufacturing and packaging is a constant. In this time of increased flux, companies must strive to retain their competitive edge by establishing a foundation of trust and experience combined with a spirit of flexibility. For contract manufacturers servicing customers ranging from Fortune 100 powerhouses to the newest startups, it’s paramount to have a sound leadership team focused on a few key operating principles. In this way, medical device contract manufacturing and packaging...
Source: MDDI - May 22, 2020 Category: Medical Devices Authors: Aaron Swanson Tags: Contract Manufacturing Source Type: news

Overcoming the Medical Device Miniaturization Wall
Motors and motion control components continue to shrink. The miniaturization trend allows manufacturers to install motors and motion control into smaller and smaller form factors. When components come down to size, signals travel shorter distances within devices, which leads to faster performance speeds. This is particularly important in medical devices and applications. Yet users need to learn the architecture of miniaturization in order to make it effective. There is a wide range of miniature components for medical devices. (Image source: maxon motors) Design News is offering a free webinar on the topic, The Miniaturiza...
Source: MDDI - May 22, 2020 Category: Medical Devices Tags: Design News Source Type: news

Abbott Lands IgG Antibody Testing Contract with U.K. Government
Abbott Laboratories is slated to provide millions of IgG lab-based antibody tests to U.K. government in the latest chapter of the COVID-19 story. The Abbott Park, IL-based company has already shipped 800,000 tests to National Health Service (NHS) laboratories across the U.K. Abbott said its SARS-CoV-2 IgG will be available on its ARCHITECT i1000SR and i2000SR and Alinity i laboratory instruments. As one of the most widely used laboratory systems in the world, the ARCHITECT system can run up to 100 to 200 tests per hour to help hospitals and laboratories with reliable antibody testing during the pandemic. The company said t...
Source: MDDI - May 22, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news

Google Search Trends Show Elective Surgery Is Still Down, But Improving
As more U.S. states begin to resume elective surgeries, hospitals and medical device companies have a strong financial incentive to see procedure volumes return to normal. The tough part, however, is convincing patients that it's safe to have them done now. In the first of what is expected to be a weekly report, Needham & Co.'s medtech analyst, Mike Matson, said he is tracking elective surgery searches using Google Trends to gauge the recovery pace of elective procedure volume in the United States. Matson noted that Google searches for 20 different types of el...
Source: MDDI - May 21, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news

Google and Apple Launch Highly Anticipated Contact Tracing Technology
Google and Apple said they have launched the Exposure Notification technology for the novel coronavirus (COVID-19). The technology is a software tool kit that would notify someone if they may have come in contact with a person that was diagnosed with COVID-19. The companies said the Exposure Notification has the specific goal of rapid notification, which is especially important to slow the spread of the disease with a virus that can be spread asymptomatically. In a joint release the duo said, “what we’ve built is not an app—rather public health agencies will incorporate...
Source: MDDI - May 21, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Digital Health Source Type: news

Supplier Stories for the Week of May 17
(Source: MDDI)
Source: MDDI - May 21, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news

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 21, 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. "...
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