Livingston Reporting - page 73

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• Further developing the proposed regulatory framework, including through the issuance of draft guidance on a predetermined change control plan (for software to learn in time)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

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.