Stryker Announces They Have Released their Emergency Relief Bed™: A Limited-Release Medical Bed to Support Sritical Needs During a Pandemic

April 3, 2020

Stryker has developed a low-cost, limited-release emergency response bed, Emergency Relief Bed™, to quickly aid healthcare providers with efficient care during the COVID-19 pandemic.

Brad Saar, president of Stryker’s Medical division notes, “People are at the heart of what we do, and COVID-19 hasn’t changed that. It has amplified our mission of making healthcare better. We’re focused on meeting the supply needs of our customers so they can focus on taking care of patients right now. He concluded, “That’s why we raced to develop our Emergency Relief Bed, which will help emergency responders and caregivers move and position patients efficiently during this critical time.”

Stryker anticipates producing 10,000 beds a week to meet increased needs.

Stryker’s Emergency Relief Bed is a low-cost, readily available solution intended to serve those on the front lines – ranging from hospital emergency departments to triage and pop-up areas of care. It includes a six-inch-thick foam surface.

The Emergency Relief Bed features a 30-degree head of bed angle to accommodate patients in respiratory distress, including ventilated patients. It also features low height and an attached IV pole.

The bed is intended for use in the COVID-19 pandemic to support increased patient numbers in healthcare facilities. Stryker is actively pursuing making the bed available in select markets around the world.

FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic

April 2, 2020

As part of the U.S. Food and Drug Administration’s ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, today the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.

The COVID-19 pandemic has caused unprecedented challenges to the U.S. blood supply. Donor centers have experienced a dramatic reduction in donations due to the implementation of social distancing and the cancellation of blood drives.

Maintaining an adequate blood supply is vital to public health. Blood donors help patients of all ages – accident and burn victims, heart surgery and organ transplant patients and those battling cancer and other life-threatening conditions. The American Red Cross estimates that every two seconds, someone in the U.S. needs blood.

People who donate blood are part of our critical infrastructure industries. More donations are needed at this time and we hope people will continue to take the time to donate blood. We have also encouraged, and continue to encourage, state and local governments to take into account the essential nature of donating blood – and that it can be done safely and consistently within social distancing guidelines – when considering travel and business restrictions, and we encourage them to communicate that to their citizens.

At the FDA, we want to do everything we can to encourage more blood donations, which includes revisiting and updating some of our existing policies to help ensure we have an adequate blood supply, while still protecting the safety of our nation’s blood supply.

Based on recently completed studies and epidemiologic data, the FDA has concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply. Therefore, the FDA is revising recommendations in several guidances regarding blood donor eligibility. These changes are being put forth for immediate implementation and are expected to remain in place after the COVID-19 pandemic ends, with any appropriate changes based on comments we receive and our experience implementing the guidances. At this time, the alternatives to certain donor eligibility requirements being provided generally will apply only for the duration of the declared pandemic.

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Among others, the FDA is making the following changes, for immediate implementation, to the December 2015 guidance:

For male donors who would have been deferred for having sex with another man: the agency is changing the recommended deferral period from 12 months to 3 months.
For female donors who would have been deferred for having sex with a man who had sex with another man: the agency is changing the recommended deferral period from 12 months to 3 months.
For those with recent tattoos and piercings: the agency is changing the recommended deferral period from 12 months to 3 months.

Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

The FDA is making the following changes, for immediate implementation, to the August 2013 guidance:

For those who have traveled to malaria-endemic areas (and are residents of malaria non-endemic countries): the agency is changing the recommended deferral period from 12 months to 3 months. In addition, the guidance provides notice of an alternate procedure that permits the collection of blood and blood components from such donors without a deferral period, provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

The FDA is finalizing the January 2020 draft guidance, which includes the following change from the previous guidance:

For those who spent time in certain European countries or on military bases in Europe who were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease, the agency is eliminating the recommended deferrals and is recommending allowing reentry of these donors.

To help address this critical need, the FDA is also providing notice of alternatives to certain requirements regarding blood donor eligibility for the duration of the COVID-19 pandemic. Blood establishments are not required to implement the changes in the FDA recommendations or the alternative procedures.

We expect that the updated guidance and alternative procedures will help increase the number of donations moving forward, while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients.

We believe these updated recommendations will have a significant and positive impact on our blood supply. As noted above, the changes being announced to the HIV, vCJD and malaria guidances are being put forth for immediate implementation. The updated recommendations in these guidances are based on data and analysis that the FDA believes are applicable to circumstances outside of (and after) the COVID-19 pandemic and reflect the agency’s current thinking on this issue. These recommendations are expected to remain in place after the COVID-19 pandemic ends, with any appropriate changes based on comments we receive and our experience implementing the guidances.

The FDA will provide notification when the alternative procedures are no longer in effect. The FDA will monitor these changes in policy, alongside the National Institutes of Health’s National Heart, Lung and Blood Institute and major blood partners to ensure the continued safety of the blood supply.

Additional Resources:

Coronavirus Disease 2019 (COVID-19)

EyeOn LifeLine Is a Potentially Life-Saving Eye Tracking Communication Tablet for Hospital ERs and ICUs

April 2, 2020

EyeTech Digital Systems has launched FDA-registered EyeOn LifeLine, a potentially life-saving eye-tracking communication tablet for hospital ERs and ICUs, so doctors, nurses and caregivers can easily and quickly communicate with their critical COVID-19 patients, who are unable to speak while confined to their hospital beds.

The stand-mounted tablet faces the patient who simply looks at word squares to express pain level or a request, and the tablet voices it through speakers for nurses and doctors.

EyeOn LifeLine is ultra-portable so it can be utilized with multiple patients during this pandemic, to improve patient outcomes.

EyeTech launched the EyeOn self-calibrating augmented and alternative communication (AAC) device earlier this year for people with ALS, cerebral palsy, muscular dystrophy, spinal cord injuries, Rett Syndrome, traumatic brain injuries or stroke as well as those on the autism spectrum. But the entire team jumped into action to modify the software and firmware to create EyeOn LifeLine, so COVID-19 patients can communicate critical needs to their healthcare workers while intubated or using a ventilator or respirator.

“As a long-time eye-gaze user with hand disabilities, I was devastated to see doctors and nurses not being able to communicate with ICU patients under a ventilator,” EyeTech CEO Robert Chappell said. “If we can save one life, it will be a huge contribution. I just wish we had enough units to serve all the ICUs around the country. Chappell concluded, “We are also donating $500 per unit to the American Nurses Foundation to express our heartfelt support to those fighting this pandemic on the frontlines.”

Tablo® Hemodialysis System Receives FDA Clearance for Home Dialysis

April 2, 2020

Outset Medical has announced the Food and Drug Administration (FDA) cleared the Tablo® Hemodialysis System for patient use in the home. The new home clearance expands Tablo’s existing labeled indication for use in acute and chronic care facilities, which for the first time enables healthcare providers the same dialysis machine from the ICU to the home.

Tablo enters the market at a critical time in the midst of the COVID-19 pandemic and renewed national focus on home dialysis for improving patient outcomes while lowering cost. In mid-2019, President Trump and United States Department of Health and Human Services Secretary Alex Azar announced an Executive Order to help Americans with kidney failure. A major component of the policy was ensuring 80% of all new dialysis patients start therapy at home or get transplanted by 2025. The emergence of COVID-19 further heightens the urgency for giving current in-center dialysis patients the option to treat at home.

“Tablo was designed to simplify dialysis, making it easier and more accessible for patients to take advantage of the safety, convenience and flexibility of dialyzing at home,” said Outset Medical Chief Executive Officer, Leslie Trigg. “We are proud to offer them this new, life-enhancing option, particularly in light of the COVID-19 related challenges dialysis patients and providers are experiencing.”

Currently, more than 500,000 Americans undergo dialysis treatments three or more times each week, typically lasting four hours per treatment. Approximately 100,000 new patients start treatment annually. Yet only 12% receive it at home where they’re more comfortable, productive and empowered.

A prospective, multicenter, home hemodialysis trial with 30 patients was completed in 2019 and confirmed the Tablo system is safe and effective for home use. The results were published in November 2019 in Hemodialysis International.

Troy Plumb, M.D., the principal study investigator and the Division Chief of Nephrology and Associate Professor of Medicine at the University of Nebraska Medical Center College of Medicine in Omaha, said, “My patients, colleagues and I are excited for Tablo to be available for home use. The trial made it clear the system is easy to learn and performs well in the home environment. I believe that Tablo will open up opportunities for patients to pursue home hemodialysis and take more control over their lives and care.”

One of those patients is 62-year-old Texas resident and technology consultant Richard Crawford. He has had a kidney transplant that lasted 17 years and is currently on a transplant list. Over the years, he has had thousands of dialysis treatments at various centers as well as on home hemodialysis. He found using Tablo at home to be very intuitive, allowing him to dialyze while remaining productive during treatment.

“The home part of the Tablo trial only lasted eight weeks, but was eye-opening,” he said. “The system is extremely easy to set up and use, so I wasn’t wasting hours on dialysis-related tasks. I was able to work at my desk during treatments, which was wonderful for my productivity. The system provided me with a new level of independence due to the ease of setup and maintenance. “When the trial ended and they had to pick up the Tablo, I tried talking them out of it. I really hated seeing it go.”

Outset will begin a controlled rollout for home use at select sites over the coming months to ensure the highest level of training and support for Tablo home patients. This program will be balanced with the need to supply health systems, hospitals, and clinics with devices to support a surge of demand for dialysis treatments driven by COVID-19. More information about availability for patients and providers can be found here

Tablo was designed in Silicon Valley to reduce the cost and complexity of dialysis care. Requiring only an electrical outlet and tap water to operate, the mobile Tablo system frees patients and providers from expensive clinic infrastructure. The machine’s functionality enables it to serve as a dialysis clinic on wheels. Wireless data, sensor-based automation and an animated touchscreen make the system easy to learn and use. Leading health systems and medical centers across the U.S. use Tablo for hospital and clinic dialysis, and the U.S. Department of Health and Human Services (HHS) awarded a contract for the use of Tablo in communities hit by natural disasters.

Signatera Technology for Personalized Monitoring in Gastrointestinal Cancer Shows Benefits According to a New Study

April 2, 2020

A new, peer-reviewed case study published in JCO Precision Oncology¹ demonstrates the unique ability of Signatera technology to detect esophageal cancer recurrence almost one year before current standards of care, using a simple blood draw to monitor for traces of circulating tumor DNA (ctDNA).

This report builds upon a fast-growing body of scientific evidence behind the Signatera test across multiple cancer types.

The study follows a 72-year old man with recurrent Stage III esophageal cancer whose recurrence was detected 350 days before radiographic imaging, using Signatera’s personalized and tumor-informed technology. After undergoing multiple CT scans showing no signs of cancer, the patient’s physicians escalated to a PET scan, which revealed a 4 cm nodule in his liver that was later surgically removed. The full study can be found here.

“This case study illustrates the potential advantage of using personalized ctDNA testing as a surveillance tool, especially in the current environment with COVID-19,” commented senior author Eirini Pectasides, M.D., Ph.D., a medical oncologist specializing in gastrointestinal cancer at Dana-Farber Cancer Institute and instructor in medicine at Harvard Medical School.

In the era of COVID-19 and social distancing, where cancer patients are among those with the highest risk of mortality from exposure to the virus, many oncologists are cancelling routine surveillance visits and looking for remote monitoring solutions. In response to the pandemic, Natera has announced a temporary GI Cancer Expanded Access Program that offers compassionate use of the Signatera test for patients with any form of GI cancer through July 31, 2020, including esophageal cancer, which was the focus of the case study. Details of the Expanded Access Program can be found here.

“Patient anxiety around cancer recurrence can be immense,” commented Solomon Moshkevich, General Manager of Natera’s Oncology business. “This case exemplifies the value of early recurrence detection, through blood testing that can be accessed remotely from one’s home.”

Signatera has been validated across multiple cancer types to detect molecular residual disease (MRD) up to 2 years earlier than standard diagnostic tools,^2-5 with virtually no false positives (< 0.3%).³ While a negative test result does not mean someone is definitely cancer-free, it does mean the risk of relapse is significantly reduced. These results, in conjunction with clinical and pathological risk assessment, may help patients avoid treatment with chemotherapy that can weaken the immune system.

References:

Einstein DJ, Liang N, Malhotra M, et al. Assessment of molecular remission in oligometastatic esophageal cancer with a personalized circulating tumor DNA assay. JCO PO. 2020;4:239-243.
Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.
Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-426.
Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019; 37(18):1547-1557.

AMRA Medical and Fulcrum Therapeutics Develop MRI Method for Multi-site Neuromuscular Clinical Trials

April 2, 2020

Clinical trial investigators commonly use functional tests such as the 6-Minute Walk Test and single-slice MRI to evaluate neuromuscular disease progression. These techniques can vary substantially, creating unwanted data noise – potentially making trials larger, longer and more costly. Additionally, there is a lack of standards for implementing whole-body MRI in multi-center trials, making it challenging to quantify how the disease affects individual muscles throughout the body in different stages of the disease. Lastly, neuromuscular disease studies often emphasize only the legs. This study includes whole muscle volumes in the legs, trunk, shoulders, and arms.

AMRA Medical and Fulcrum conducted a study to evaluate, optimize and standardize a whole-body MRI protocol for use in clinical trials for Fulcrum’s losmapimod – a small molecule investigational therapeutic for FSHD. Together, they successfully developed a detailed musculoskeletal MRI protocol to quantify muscle fat fraction, lean muscle volume, and muscle fat infiltration. They volumetrically and bilaterally analyzed 18 individual muscles in 16 adults with FSHD across 6 clinical sites using diverse MRI scanner manufacturers. Fulcrum recognizes that AMRA’s technology is a significant advancement in neuromuscular clinical trials and plans to use this protocol as part of the further development of losmapimod.

Diego Cadavid, Fulcrum Therapeutics’ Senior Vice President of Clinical Development says, “Commonly used endpoints – such as functional tests – have limitations, so we engaged with AMRA based on their ability to reliably and quickly segment and quantify muscles. Together we developed an MRI protocol that generates stable images from which AMRA’s algorithms produce consistent, quality, objective and reproducible biomarkers that we now use in our ongoing clinical trial program.”

This study further demonstrates that AMRA’s MRI technology: 1) has the potential to follow heterogeneous disease distribution; 2) is compatible with major MRI scanner manufacturers, making multicenter trials more feasible; 3) can perform whole-body 3D volumetric measurements of individual muscles and muscle groups, enabling earlier and more accurate detection of fat and muscle changes; and 4) can longitudinally monitor several different muscles specific to the neuromuscular disorder and patient.

These results rationalize the exploration and use of AMRA’s methods in additional neuromuscular clinical trials. The full abstract for Development and Evaluation of a Whole-Body MRI Imaging Protocol And Analysis Algorithms to Measure Changes in Skeletal Muscle in FSHD (#142) can be viewed on the MDA 2020 website.

Jay M Moyes Appointed New CFO of Sera Prognostics

April 2, 2020

Jay M Moyes joins Sera Prognostics as it transitions from rigorous scientific and groundbreaking clinical-stage company into a rapidly growing commercial organization.

For more than two decades, Jay Moyes has served in C-level executive and board positions of both private and public companies. He currently serves as Director on the public boards of Achieve Life Sciences (NASDAQ: ACHV), BioCardia (NASDAQ: BCDA) and Puma Biotechnologies (NASDAQ: PBYI). Previous roles include board director service with Predictive Technology Group (PRED); Osiris Therapeutics (OSIR); and Integrated Diagnostics (acquired by Biodesix). Jay also served as Chief Financial Officer and Director of the publicly traded biomaterials company, Amedica Corporation (now SINTX Technologies), managing the company’s IPO and listing on NASDAQ; and as Chief Financial Officer at XDx (now CareDx – CDNA).

At Myriad Genetics (MYGN) , Jay led the finance function for 14 years from the company’s early private stage development beginning with 7 employees, through its successful IPO in 1996, and serving until 2007 as Chief Financial Officer during Myriad’s rapid growth trajectory to become one of the world’s most highly profitable molecular diagnostics companies, with over 900 employees. During that time, Moyes spearheaded the efforts in raising more than $500 million in public and private financings.

“I am thrilled to be working with Jay Moyes again, as we build Sera Prognostics into a highly successful and profitable enterprise,” said Gregory C. Critchfield, MD., MS, chairman and CEO. “Jay’s deep financing connections and expertise in leading biopharmaceutical, medical device and diagnostics companies, both in private and public company settings, will help Sera to achieve its vision of improving the health of mothers and babies and reducing the costs of healthcare delivery.”

Sera has achieved remarkable progress in building a world-class approach to address the immense burden of premature birth,” said Jay Moyes. “The early data from outcome study reports show that Sera’s PreTRM^® strategy works, and that by improving the health of women and babies, the enormous personal, societal and economic consequences of prematurity can be mitigated. I am excited to join the talented Sera team and help accelerate the company’s progress, as Greg and I successfully did together at Myriad.”

Scopio Labs Receives CE Mark for X100 Microscope and Decision Support System With Full Field Peripheral Blood Smear (PBS) Application

April 1, 2020

Apr 13, 2020

Scopio Labs is a company advancing digital microscopy, today announced it has received CE mark certification for its X100 Full Field Peripheral Blood Smear (Full Field PBS) all-digital morphology analysis platform. As the first digital microscope to scan and analyze entire regions of interest from a slide in high resolution, Full Field PBS enables remote consultation and includes a computer-vision based decision support system, advancing manual microscopy into the digital age.

Scopio Labs, to date, has demonstrated accurate results on hundreds of patient samples in Tel Aviv Sourasky Medical Center – Ichilov Hospital.

Accelerating the diagnostic process by scanning and digitizing large areas of the slide in high resolution, Scopio Labs helps facilitate efficient review of digital slides and uses its built-in AI tools to compile a detailed report that can also be remotely shared with experts. Today, a significant number of hematology diagnostic tests continue to be performed using manual microscopes, increasing potential for human error, creating silos of information and delaying life-sustaining decisions.

“The clinical validation of Full Field PBS furthers our efforts to bring the digital revolution into the laboratory and improve the outcome of care across medicine,” said Itai Hayut, co-founder and CEO of Scopio Labs. “Digitization is a crucial advancement for hematology labs. With plans to provide additional assistive tools for all microscopy-based hematology diagnostics and unlock new capabilities for the industry, we are thrilled by the positive impact the Full Field PBS system can provide to our partners.”

The Full Field PBS offers an end-to-end decision-support tool for clinicians. Its digitized scans are reconstructed with cutting-edge computational photography tools at 100X equivalent magnification and at oil-immersion resolution levels. Built-in machine learning tools then pre-classify cells within the slide and create a data summary of the results. The image data, as well as the data summary, can be reviewed by experts in multiple locations – in the lab that generated the samples, and in other labs within the organization’s network. Scopio Labs platforms are scalable, suit a variety of both large and small labs, easily integrate with standard processes and are market-ready.

“The medical profession is always looking to improve patient outcomes and advance care,” said Ben-Zion Katz, Director, Hematology Laboratories at Ichilov Hospital. “However, manual microscopy requires experts to choose between platforms that offer a large field of vision or high resolution. By digitizing microscopy slides and reconstructing them into high resolution and quality scans that can be shared and analyzed remotely, Scopio Labs’ Full Field PBS offers hematologists the best of all worlds, and as a result, the opportunity to significantly reduce turnaround times and accelerate treatment initiation, giving each patient the best chance of success.”

Tel Aviv Sourasky Medical Center (Ichilov) is the largest acute care facility in Israel, managing 1.8 million patient visits per year. The institution installed the Scopio platforms in 2019, and conducted hundreds of tests on patient samples, comparing the analysis quality to standard workflows.

Henry Schein Announces Further Efforts to Address the COVID-19 Pandemic

April 1, 2020

“Henry Schein is committed to bringing essential products to the health care professionals who are fighting the pandemic,” said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein. “During this unprecedented crisis, health care professionals need rapid diagnostic tools and personal protective equipment (PPE) to protect their safety and the safety of the population. In conjunction with our suppliers, we are determined to make these essential products available.”

Working with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and BioMedomics, a privately held, North Carolina-based clinical diagnostics company, Henry Schein will make the test kits available to health care professionals as part of the Company’s broad offering of point-of-care rapid tests.

The BioMedomics test analyzes blood, serum, or plasma samples for the presence of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). The test is completed in four simple steps. First, blood is collected through normal blood collection devices, and then a few drops are transferred to the test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes.

“The BioMedomics serology test has been validated in numerous hospitals around the world and will be a critical tool to detect current or past exposure to COVID-19,” said Dave Hickey, President of Integrated Diagnostic Solutions for BD. “We are proud to work with Henry Schein, a leader in the point-of-care segment, to get these tests to health care providers as quickly as possible.”

The agreement with BD and BioMedomics builds on Henry Schein’s announcement last week of an antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test, which is also administered at the point of care and delivers results within 15 minutes from a pinprick with no instrumentation required.

“The COVID-19 rapid test kits are a part of Henry Schein’s response to the outbreak. These tests are important because they are fast and can be deployed where they are needed to help return our citizens to the workforce,” Mr. Bergman said. “We believe public health officials can also use these tests to better understand the spread of the disease.”

The Company is also a participant in the White House’s COVID-19 Supply Chain Task Force, and has worked with the Strategic National Stockpile to deliver PPE to COVID-19 testing sites.

Henry Schein’s Brad Connett, President, U.S. Medical Group, participated in a meeting at the White House on March 29 of the COVID-19 Supply Chain Task Force. As part of that effort, the Company is working with the Federal Emergency Management Agency (FEMA) to source and deliver critical supplies quickly.

“Understandably, demand for test kits and PPE is acute, and the industry’s supply chain, as of today, is challenged to provide the volumes that customers require,” Mr. Connett said. “We are prioritizing shipments of these critical products for use by those health care professionals on the front line of the COVID-19 pandemic.”

At the meeting, Mr. Connett also stressed the importance of increasing the manufacturing of PPE in the United States to avoid future shortages.

Henry Schein has a long-standing record of addressing pandemic preparedness and response. Among other efforts, Henry Schein is in direct contact with the World Health Organization and other multilateral and domestic organizations as part of the Company’s role as the private-sector lead of the Pandemic Supply Chain Network, a public-private partnership created in 2015 to improve the efficiency of the supply chain for personal protective equipment.

To learn more about what Henry Schein is doing to address this unprecedented situation and the actions the Company is taking to get more product into the hands of those who need it most – health care workers – please visit here.

For customers interested in more information about the antibody rapid test kits, please contact Henry Schein at (844) 211-0140.

Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing may be considered to further evaluate the possibility of SARS-CoV-2 infection. The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on March 16, 2020.

Synchrocyclotron for the MEVION S250i Proton Therapy System Delivered to Huntsman Cancer Institute

April 1, 2020

Mevion Medical Systems announced today that it has delivered the synchrocyclotron accelerator for the MEVION S250i Proton Therapy System® to Huntsman Cancer Institute (HCI) at the University of Utah (U of U) on March 28, 2020. The 15-ton accelerator, the world’s smallest, was driven up the side of the Red Butte Canyon and was lowered by a crane into the proton facility the same day.

“With the arrival of the accelerator, we are on track to provide proton therapy to our patients later this year,” said Dennis Shrieve, M.D, Ph.D., radiation oncologist at HCI and professor and chair of radiation oncology at the U of U.

The system, now under installation, features Mevion’s industry-leading HYPERSCAN® Pencil Beam Scanning (PBS) technology. HYPERSCAN improves on existing scanning capabilities to deliver more conformal fields of therapeutic radiation to tumors faster, with more precision and is the most advanced pencil beam scanning available. HCI, Utah’s only National Cancer Institute-designated Comprehensive Cancer Center, has been closely tracking and considering proton therapy for over a decade. Recent technological advances by Mevion made it the right time to add this powerful cancer-fighting tool to their cancer center. HCI will also integrate* Siemen’s SOMATOM® Definition Edge CT on rails to provide precise image-guided proton therapy (IGPT).

“Proton therapy is especially effective in delivering targeted radiation while preserving healthy tissues. Patients with tumors close to critical organs along with pediatric cancer patients can benefit the most from this advanced treatment,” said Bill Salter, Ph.D., director of radiation oncology at HCI and professor and chief of the division of medical physics at the U of U. “The HYPERSCAN system will be a powerful new addition to Huntsman Cancer Institute’s already formidable suite of treatment tools.”

By reducing the size and complexity of a proton therapy system, Mevion has allowed hospitals to offer proton therapy without the enormous expenditures and space requirements needed by other single-room or multi-room proton systems. Today, more cancer centers are considering providing compact proton therapy to their patients because of the technology Mevion has advanced.

“We are honored to provide Utah with the first proton therapy center in the Mountain West,” said Tina Yu, Ph.D., chief executive officer of Mevion Medical Systems. “HCI is a nationally recognized research center and treatment hospital and we look forward to building our partnership to advance the science and application of proton therapy.”

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Stryker has developed a low-cost, limited-release emergency response bed, Emergency Relief Bed™, to quickly aid healthcare providers with efficient care during the COVID-19 pandemic.

As part of the U.S. Food and Drug Administration’s ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, today the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.

A new, peer-reviewed case study published in JCO Precision Oncology1 demonstrates the unique ability of Signatera technology to detect esophageal cancer recurrence almost one year before current standards of care, using a simple blood draw to monitor for traces of circulating tumor DNA (ctDNA).

Medical Device News Magazine

A new, peer-reviewed case study published in JCO Precision Oncology¹ demonstrates the unique ability of Signatera technology to detect esophageal cancer recurrence almost one year before current standards of care, using a simple blood draw to monitor for traces of circulating tumor DNA (ctDNA).