This is our fourth FDA clearance expanding our wireless platform and enhancing our core continuous waveform technology and artificial intelligence algorithms,

John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform, wrote this article. The FDA's approach to software as a medical device (SaMD) has been evolving. In 2018, IDx-DR, a software system used to improve screening for retinopathy, a common complication of diabetes that affects the eye, became the first AI-based medical device to receive US Food and Drug Administration clearance to "detect greater than a mild level of … diabetic retinopathy in adults who have diabetes." To arrive at that decision, the agency not only reviewed data to establish its safety, it also took into account prospective studies, an essential form of evidence that clinicians look for when trying to decide if a device or product is worth using. The software was the first medical device approved by the FDA that does not require the services of a specialist to interpret the results, making it a useful tool for health care providers who may not normally be involved in eye care. The FDA clearance emphasized the fact that IDx-DR is a screening tool not a diagnostic tool, stating that patients with positive results should be referred to an eye care professional.

Over the last couple of years, there has been much discussion about the benefits of artificial intelligence (AI) for improving healthcare. But how much of this is true and how much simply hype? Is the technology really a godsend to radiologists and other healthcare professionals, or is it making their lives more difficult? There is no doubt that AI-based image recognition technology has improved enormously in recent years. Many researchers and companies are now working on different types of programs with a view to improving speed, accuracy and costs of cancer screening.

The US Food and Drug Administration (FDA) has authorized marketing of artificial intelligence (AI) software to help pathologists detect prostate cancer. The program, called Paige Prostate, is the first approved AI system in pathology. "We really believe this product can make a huge difference," Paige CEO Leo Grady, PhD, told Medscape Medical News. The program was approved as an adjunct to pathologist review, not a replacement. Grady explained that "for a second opinion today, you ship a glass slide to somebody else or you do another stain that's really expensive or you do another molecular test."

The FDA has authorized the first artificial intelligence software to help doctors detect prostate cancer. The program, called Paige Prostate, is the first approved AI system in pathology. "We really believe this product can make a huge difference," Paige CEO Leo Grady, PhD, says. The program was approved to help doctors, not to replace them. "For a second opinion today, you ship a glass slide to somebody else or you do another stain that's really expensive or you do another molecular test," Grady says.

"Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives." Cancer that starts in the prostate is called prostate cancer. According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, prostate cancer is the most common cancer among men in the United States.

NEW YORK--(BUSINESS WIRE)--Paige, the global leader in AI-based diagnostic software in pathology, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for Paige Prostate, a clinical-grade AI solution for prostate cancer detection. As a novel technology, Paige Prostate is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic (IVD) use via Paige's FDA-cleared FullFocus digital pathology viewer. With a projected 60 percent increase in the number of cancer cases globally in the next two decades and a decrease in the number of pathologists relative to this diagnostic demand, there is a significant need to provide new technologies for the practice of pathology. Paige Prostate is a cancer detection solution that identifies foci suspicious for cancer and provides this information to the pathologist. Paige Prostate is designed to assist pathologists in finding small foci of cancer and enable pathologists to work efficiently and confidently in their diagnostic process.

The FDA has authorized the marketing of Paige Prostate, an AI-based software platform to help pathologists identify prostate cancer when they review slide images from prostate biopsies.1 The standard biopsy review process involves the pathologist examining digitally scanned slide images from prostate biopsies to find areas that are suspicious for cancer. Paige Prostate provides a supplementary assessment of the image and locates the area with the highest probability of harboring cancer. The pathologist can then examine this specific area further if they did not identify it on their initial assessment. "Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment," Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, stated in a press release.

Sepsis is a huge healthcare concern. "You take every single cancer and all the deaths due to every single cancer and you add them all up together. More people die from sepsis worldwide than that," said Bobby Reddy, Jr., CEO of Prenosis, in an interview with MD DI. And even if patients survive, they can have lifelong consequences. "Sepsis occurs when you have a very abnormal, unhealthy reaction to infection," Reddy said.

Fox News Flash top headlines are here. Check out what's clicking on Foxnews.com. President Biden took major hits this week, from the Pentagon confirming that a "tragic mistake" led to 10 civilians in Afghanistan dying in a drone strike, to the Food and Drug Administration rejecting his vaccine booster proposal, with much of the news breaking as the president headed to the beach for vacation. "So the U.S. drone strike did NOT kill any ISIS-K but did kill 10 innocent civilians, including 7 children. The Biden administration is a sad, tragic mess and an utter embarrassment on the world stage!,"