Artificial Intelligence Learning Action Plan Released by FDA

The United States Food & Drug Administration (FDA) has released their first Artificial Intelligence (AI) and Machine Learning (ML)-Based Software as a Medical Device (SaMD) Action Plan. Detailed throughout the plan is a multi-pronged approach to “Advance the Agency’s oversight of AI/ML-based medical software,” according to the article.

Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH) said, “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD. The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”

Five actions that the FDA intends to take based on the action plan include:

  • Further developing the proposed regulatory framework, including through the issuance of draft guidance on a predetermined change control plan (for software to learn in time)
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms
  • Fostering a patient-centered approach, including device transparency to users
  • Developing methods to assess and enhance machine learning algorithms
  • Advancing real-world performance monitoring pilots

This action plan was sparked by stakeholder feedback and is implemented as a response to the discussion. The FDA welcomes continual input and will continue to collaborate and build a coordinated approach in AI/ML areas.

The FDA is responsible for the safety and security of America’s food supply, cosmetics, dietary supplements, products that emit radiation, and regulating tobacco products. The agency also protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, biological products for human use, and medical devices.

To read more about the FDA’s Action plan, see the full press release on their website.

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Study Shows Drastic Decline in Cancer Screenings During COVID-19 Surge

According to a study published in JAMA Oncology by researchers at Dana-Farber/Bringham and Women’s Cancer Center, researchers documented a sharp drop in cancer and pre-cancer diagnoses at the Northeast’s most extensive health care system. Due to the first peak of the COVID-19 pandemic, a decrease in the number of screenings occurred.

Documented as one of the first studies to examine the impact of COVID-19 on cancer diagnoses, the findings confirm concerns that restrictions might have delayed the detection of many cancers. In the months following the initial peak, cancer screenings and diagnoses rebounded to pre-pandemic levels.

“It’s widely thought that fewer people were screened for cancer and pre-cancerous lesions during the first surge of the pandemic, because limitations on non-urgent medical procedures, restrictions on patient volume, patients’ concerns about the spread of the virus, and the need for social distancing,” said Ziad Bakouny, M.D. MSc, a co-author of the study. “For this study, we wanted to document the extent of this deadline, and its impact on cancer diagnoses, at a major U.S. healthcare system.”

Patient data from the Massachusetts General Bingham system of hospitals were used for the study. The number of mammograms, colonoscopies, Papinicolaou (“Pap”) tests for cervical cancer, prostate-specific antigen (PSA) tests, and low-dose Computed Tomography (CT) tests was all tracked for four three-month periods. March 2 to June 2, 2020, the previous three months, the subsequent three months, and the same three months in 2019 were all used in the study.

During the peak period, the statistics show a sharp decline in cancer screenings. In 2019, between March and June, 60,344 patients underwent screening exams. In 2020, a total of 15,453 patients had screening exams, compared to 64,269 in the previous three months. In the post-peak three-month period, screening levels mostly recovered to 51,944.

Unexpectedly, cancer diagnoses also declined during the COVID-19 peak. The researchers estimated that roughly 1,438 cancers and pre-cancerous growths were left undiagnosed during that period. Cancers are easier to treat when detected at early stages, so those that were overlooked could potentially be worse or life-threatening.

Bakouny remarked, “It’s reassuring, though, to see that in the three-month post-peak period, the number of screening tests and diagnoses resulting from those tests returned to near-normal level.”

Co-senior author Quoc-Dien Trinh, M.D., of Bingham and Women’s Hospital (BWH), said, “This investigation is especially timely given that we are currently dealing with a second, and potentially worse wave of the pandemic. We have learned to leverage a redesigned patient flow, increased use of telehealth, and made other accommodations to allow our patients to continue in receiving cancer screenings in the safest possible environment.”  

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

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New Imaging Can Measure Cell Dysfunction in ALS Patients

More effective therapies could potentially be introduced thanks to a new magnetic resonance spectroscopy technique that can accurately measure how well the mitochondria are functioning in patients with Amyotrophic Lateral Sclerosis (ALS.) This non-invasive procedure may help measure the efficacy of treatments for ALS (also known as Motor Neuron Disease [MND]) patients.

Scientists from Sheffield Institute for Translational Neuroscience (SITraN) from the University of Sheffield in the United Kingdom tested how the 31-phosphorus magnetic resonance spectroscopy performed, publishing their findings in the January 13 issue of Brain.

Lead study author Dr. Matilde Sassani, a neurodegeneration researcher at Sheffield, said, “In this study, we found that phosphocreatine levels were depleted in the brain compared to healthy controls and, in this muscle, we found that inorganic phosphates were elevated in patients with MND. Both of these findings are consistent with mitochondrial dysfunction occurring in these people living with MND.”

People with ALS suffer from impaired mitochondrial function, so having a technique that can effectively and accurately measure mitochondrial activity could be critical to treatment.

In the study, the imaging technique was used to measure a chemical involved in the cell’s energy metabolism. ALS patients were compared to healthy age and gender-matched controls. The procedure resembles an MRI; the process allows investigators to capture a direct measurement of chemicals. This snapshot gives them the appropriate data needed to calculate a comprehensive view of a patient with MND.

Senior author Dr. Thomas Jenkins, a clinical senior lecturer at SITraN, said the newfound technique could pave the way for more effective MND treatments and potentially measure how effective medications are.

Jenkins said, “Treatments that aim to rescue mitochondrial function in MND are being investigated in labs around the world. This non-invasive tool can demonstrate whether medications in development are successfully targeting mitochondria, which is an important step in selecting treatments to take through clinical trials.”

Patients with other forms of neurodegenerative diseases might also benefit from this technique, though further research is needed.

To read additional information, refer to the article in the latest issue of Brain, a Journal of Neurology.

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

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Brain Scans Can Predict Music-Induced Emotions

In Finland at the University of Turku, researchers in the national PET Centre recently discovered neural mechanisms that arise as an emotional response to music. Subjects who participated in the study (102) listened to emotion-evoking music while undergoing functional magnetic resonance imaging (fMRI).

To map which brain regions are activated based on different music-inducing emotions, researchers created a machine-learning algorithm. Postdoctoral Researcher Vesa Putkinen said, “Based on the activation of the auditory and motor cortex, we were able to accurately predict whether the research subject was listening to happy or sad music. The auditory cortex process the acoustic elements of music, such as rhythm and melody.  Activation of the motor cortex, then again, may be related to the fact that music inspires feelings of movement in the listeners even when they are listening to music while holding still in an MRI machine.”

Specific brain regions are activated when humans watch videos that evoke strong emotions. This was better discerned by the researchers who tested whether the same areas were activated while listening to music that evokes emotions. The results indicate that emotions evoked by film and sounds are based on different brain synapses.

Real-life situations are mimicked in films, which activate the deeper parts of the brain that regulate emotions. These regions were not strongly activated while listening to music, nor did it separate the music-induced emotions from one another. Researchers hypothesize this difference stems from the fact that films are more realistic in portraying real-life events that evoke emotions and brain synapses; cultural influences and personal history impact music-induced emotions based on music’s acoustic characteristics.  

In the past, music-induced emotions have been studied through classical instrumental music. Putkinen stated, “We wanted to use only instrumental music in this study as well, so that lyrics did not impact the emotions of the research subjects. However, we included film music and songs by the guitar virtuoso Yngwie J. Malmsteen.”

Click here to see a video showing how brains reacted while listening to the song “Far Beyond the Sun,” performed by Yngwie J. Malmsteen, which was used in the study. For further reading, check out the original press release from the University of Turku, published in the Cerebral Cortex Journal. To participate in their latest experiment called, “Music-Induced Emotions           in the Body,” check out Onni.  

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

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MRI Providers: Watch for Patients with Metal Face Masks & Magnetic Eyelashes

Technologists are well-aware of the possibility of metal burns from MRI machines. Due to the components of an MRI, all metal must be removed prior to patients entering Zone III, the space before entering the scanner room. The COVID-19 pandemic has forced the world to wear face masks in public indoor areas, including medical procedures. Also, of recent fashion trends, women have become more prone to use magnetic eyelashes, a beauty product that is easier to apply and remove. Both have resulted in MRI patient injuries.

The U.S. Food and Drug Administration (FDA) released a statement warning health care providers that patients might be injured if they wear face masks with metal parts during a Magnetic Resonance Imaging (MRI) exam. These small metal parts are usually found within the nose area or throughout the mask fabric. Nose clips, wires, ultrafine particles, or antimicrobial coating (silver or copper) can become hot and burn MRI patients.

This note of caution comes as a patient received burns from donning a face mask during an MRI. “The FDA is reminding patients and providers that patients should not wear any metal during an MRI,” according to the statement issued.

The Journal of Applied Clinical Medical Physics issued a report explaining how magnetic eyelashes are unsafe in an MRI; some lashes can rapidly become moving projectiles. False eyelashes are placed onto magnetic eyeliner (applied to eyelids) or discreetly clamp around natural eyelashes. Patients might forget to mention the eyelashes and MRI technicians might not notice them.

All medical providers should screen patients for MRI safety. Tiny metallic objects within face masks or fake eyelashes can easily slide past an initial assessment. If patients experience burns while wearing face masks, providers are encouraged to report the incident to the FDA. Gathered reports help the FDA improve patient safety.

For more information regarding the FDA’s warning, read the full report. The complete journal article pertaining to magnetic eyelashes can be found here.

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

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Acceletronics is Proudly a US-Exclusive Distributor of CNERGY

New solutions were discovered through a collaboration of partners in radiotherapy. CNERGY is an innovative solution for “Quality Assurance & Safety,” “Precision, Imaging, and Viewing,” “Patient Identification and Monitoring,” and “Advanced Couch Setup and Control.” These solutions were created in response to specific practical issues, employing the latest guaranteed technologies. Joining these forces will deliver synergistic precision and safety for radiologists and patients.

Accurate and safe radiotherapy treatments are achieved using CNERGY Quality Assurance and Safety. Patients are positioned in the most effective way based on image verification or CBCT registration results. This ensures safety margins are reduced around the target and critical organs. The entire workflow is secured using interlocks.

Radiotherapy treatments are unique; with CNERGY Precision, Imaging and Viewing Solutions, the best treatment will be applied. Total body treatments, fast double 2D kV, or MV imaging are all offered under CNERGY’s exclusive Image-Guided Radiotherapy (IGRT) abilities that correctly verify the patient’s position.

A crucial aspect of radiotherapy is Patient Identification and Monitoring. CNERGY ensures the correct patient receives the proper treatment. The most advanced techniques are implemented to help radiotherapy clinics abide by all current regulations.

Advanced Couch Setup and Control is a unique CNERGY solution encompassing six degrees of freedom corrections in clinic settings. The same software and user interface allow patients to be treated easily. No extra workload is needed, so non-stereotactic patients can be positioned with precision.

To learn more about the CNERGY solution, visit our website.

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

National Radiologic Week Celebrates Technologists

Few people and professions have been on the front lines of the COVID-19 pandemic as much as radiology technicians. They have directly impacted patients and taken a front-seat approach to the outbreak, as they work closely with coronavirus patients daily.

National Radiologic Technology Week (NRTW) marks the centennial celebration for the American Society of Radiologic Technologists (ASRT) but also serves as an opportunity to exhibit those who perform thousands of X-rays, MRIs, CTs, mammograms, nuclear medicine, cardiac and vascular international, and ultrasound procedures weekly. NRTW is celebrated annually to recognize the vital work of radiologic technologists across the nation. It commemorates the discovery of the x-ray by Wilhelm Conrad Röntgen on November 8, 1895.

Over 340,000 radiologic technologists have conducted chest X-rays, CT scans, and cardiac ultrasounds for COVID-19 patients. These lifesaving techniques have been critical in detecting and managing virus progression. Proper ventilation placement and ensuring patients receive appropriate care is of the utmost importance when dealing with pandemic patients.

To learn more about NRTW, check out the American Society of Radiologic Technologists website. For purchasing radiologic equipment, contact the experts at Acceletronics today.

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.


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Radiologists Urge Use of Medical Imaging and AI-Powered Solutions to Manage COVID-19

Recent high-profile cases of COVID-19 combined with the effort to aid in the ongoing battle  against the pandemic have prompted RADLogics to deploy the company’s AI (Artificial Intelligence)-Powered medical image analysis solution worldwide. The company urged U.S. clinicians to embrace medical imaging and emerging technologies such as AI. RADLogics has an AI-powered solution in place which has processed and analyzed thousands of suspected coronavirus cases globally. These efforts have eased the surging workload for radiology, ER, and ICU teams worldwide.

RADLogics strives to make its CT and X-ray AI-powered technology available to hospitals and healthcare systems throughout the U.S. This technology will assist in COVID-19 patient triage and management by providing quantitative analysis to clinical teams. Those patients who exhibit severe or worsening respiratory conditions are accurately assessed, allowing doctors to better triage patients based on those who urgently need intensive care such as ventilator support.

Moshe Becker, CEO and Co-Founder of RADLogics, said, “The use of CT and X-ray in the assessment and treatment plan for President Trump underscores the critical role that medical imaging must play in the fight against COVID-19. We must scale the capabilities of these medical imaging procedures rapidly to support clinicians, hospitals, and healthcare systems throughout the U.S. as they respond to the anticipated second wave of coronavirus and the roll-out of a potential vaccine. Now is the time for hospitals and healthcare providers to embrace and leverage the power of AI technologies and solutions to not only alleviate the increased burden associated with COVID-19 but to help support better outcomes by reducing burnout and errors while delivering better patient outcomes.”

Eliot Siegel, MD, Associate Vice Chair of Diagnostic Radiology and Nuclear Medicine at the University of Maryland School of Medicine said, “The ability of medical imaging – in combination with AI – to better discover and quantify the burden of COVID-19 has been well-documented. There would be tremendous clinical value in an AI algorithm that could establish and utilize a trajectory of change to predict which subset of patients might need more intense therapy such as medical ventilation, which subset of patients could be more confidently discharged, and predict subsequent clinical course. Today, there are many promising AI applications that have emerged that could allow us to address the major challenges that have hit the healthcare sector during the pandemic, and beyond as we plan to treat patients with COVID-related complications and as we provide diagnostic and therapeutic procedures that were delayed during the surge.”  

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Combined Study Results Indicate Possibilities for Lung Cancer Screening in New Zealand

Lung cancer screening might be one step closer to fruition in New Zealand thanks to newly discovered results by the University of Otago, published by medical journal BMJ Open. The indigenous Māori people of New Zealand are particularly susceptible to lung cancer, as their mortality rates are between three and four times higher than other ethnic groups. Around 450 Māori are diagnosed with lung cancer, and approximately 300 die from it yearly. If caught in the early stages, health outcomes for the Māori and other ethnic groups will undoubtedly improve.

To assess whether low-dose computerized tomography (LDCT) might be a cost-effective way to screen for lung cancer, Waitematā and Auckland DHBs collaborated with University of Otago researchers. Led by Associate Professor Sue Crengle (Kāi Tahu, Kāti Mamoe, Waitaha) from the University of Otago, the researchers used scientific modeling to estimate the benefits and costs of LDCT screening when it comes to a high-risk population. LDCT uses a small amount of radiation to produce an extremely clear three-dimensional image from a computerized x-ray.

“Having clarity about the cost-effectiveness of lung cancer screening provides further impetus to get this work started,” Associate Professor Crengle says. “If this works for Māori, then it will work for everyone else as well.”

Study findings suggested a national biennial lung cancer screening program is likely beneficial in terms of cost-effectiveness for not only the Māori but also the entire population of New Zealand. With early screening, the number of deaths will be reduced among the indigenous people. Countries with screening trials have seen a 20 to 26 percent reduction in lung cancer deaths.

For further reading, check out the original article by News Medical Life Sciences or the journal reference by BMJ Open.

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

PET/MRI Outperforms PET/CT in Cancer Scanning

German researchers conducted a study in an effort to investigate the difference between combining Positron Emission Tomography (PET) with (MRI) Magnetic Resonance Imaging compared to PET with Computed Tomography (CT).

The scientists published their findings in the Journal of Nuclear Medicine, where they concluded that pairing (PET) with (MRI) is more effective at detecting lesions. This discovery yields a quicker, more effective use of centralized and whole-body staging in a single step. Moreover, it reduces the level of radiation exposure, making them ideal for younger patients.

PET/CT is typically the customary route in oncology imaging and staging due to its high sensitivity and resolution. However, PET/MRI offers higher soft-tissue distinction with lower radiation exposure. This combination has been prevalently dampened because there have not been enough significantly conclusive studies to exhibit both functionality and advantages.

The analysis was conducted by board-certified nuclear medicine physicians and radiologists who determined that PET/MRI made the process of discovering lesions and classifying them easier. Researchers noted that reduction in radiation exposure was perhaps the most significant advantage of PET/MRI over PT/CT.

Further studies are needed to improve the detection of nodules with PET/MRI; however, the scientists’ conclusions highlight the increasing potential of hybrid imaging with oncology diagnostics.

Read the entire study here. Looking to upgrade your linear accelerator or radiation equipment? The specialists at RadParts can answer your questions – contact us today.

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