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  • Further developing the proposed regulatory framework, including through the issuance of draft guidance on a predetermined change control plan (for software to learn in time)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.

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.

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.

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

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.

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

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.

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

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.

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.


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

One Step Closer to the World’s Strongest Particle Accelerator

A team of researchers called the Muon Ionization Cooling Experiment (MICE) collaboration had announced the success of completing a muon beam. In the past, particles made of protons, electrons, and ions have been accelerated in concentrated beams. This new particle called muons are particles much like electrons but with a larger mass, which gives them the ability to create beams with ten times more energy than the previous largest particle accelerator, the Hadron Collider. Muons can also be used in further research on the atomic structure of materials and can see through highly dense materials that X-Rays cannot penetrate. To learn more about muons and how they are produced and how the team MICE have been successful in the cooling methods for this new scientific breakthrough, read this article

Evidence of Light Emission from the Eye During Radiotherapy

In the past, many patients had described seeing lights flashing during their radiation treatment even when their eyes were closed but no one was ever able to obtain evidence of this occurrence to prove it. Recently, new conclusions have been found by researchers at Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center that there is enough light created inside the eye to allow this visual sensation. These light emissions are very subtle and scientists are not surprised to not have had the ability to record these previously. To learn more, read this article that describes how researchers plan to further this phenomenon.  The main benefit of this research finding is the potential to improve imaging techniques in determining if radiation cuts across the eye during treatments. It also gives patients peace of mind having an explanation behind those mysterious flashings they may see.

Australian Milestone

A big milestone in Australia as Elekta announces the first Australian-dwelling patient treated with its Unity MR-Linac system. In this Yahoo Finance article, the Unity MR-Linac is described as a magnetic resonance radiation therapy system that enables personalized precision radiation therapy through real-time visualization of the tumor during treatment. The patient was at a state in the cancer’s life where treatment wouldn’t normally be possible but was able to undergo drastic improvements thanks to the Linac’s precision and ability to pinpoint tumor spots while avoiding damaging healthy tissue surrounding it. The use of this method will undoubtedly open doors for more Australian patients to undergo treatment with this new and exciting medical technology.

As an independent LINAC service company, Acceletronics is dedicated to delivering the best equipment performance and services for linear accelerators and CT scanners across all major brands and models, as well as new and refurbished LINAC systems for sale.  More information can be found online at https://www.acceletronics.com/.

Varian Radiotherapy Advancements

The VCA Pet CancerCare Centers chain just hit a milestone as 35 of its locations become the first to house Varian radiotherapy systems under a partnership between the chain and manufacturer. As claimed in this Today’s Veterinary Business article, VCA Animal Hospitals reported back in August that nearly 36 of the chain’s more than 930 locations would house the units and become branded as Pet CancerCare Centers. With this implementation comes new teams of board-certified oncology professionals to collaborate with a patient’s primary veterinarian. The goal of this partnership is to simply provide the nation with the largest network of veterinary-specific oncology centers that use the newest radiotherapy equipment with the hopes of leading the way in growth for the industry. The first several locations reside primarily in California with Indiana, Illinois, and Virginia also participating.

As an independent LINAC service company, Acceletronics is dedicated to delivering the best equipment performance and services for linear accelerators and CT scanners across all major brands and models, as well as new and refurbished LINAC systems for sale.  More information can be found online at https://www.acceletronics.com/.