Cardio-focused digital health company AliveCor landed FDA clearance for its new suite of interpretive ECG algorithms, dubbed the Kardia AI V2. This news comes just days after the company announced a $65 million Series E funding round. The new clearance will is able to capture sinus rhythm with premature ventricular contractions, sinus rhythm with supraventricular ectopy and a sinus rhythm with wide QRS. The algorithm works on AliveCor's KardiaMobile and KardiaMobile 6L devices, which even before this latest FDA clearance, have been able to take 30-second ECGs, and are hooked up to a corresponding app. According to the company's release, the algorithm will also reduce the number of unclassified readings, and has improved sensitivity and specificity on the company's normal and atrial fibrillation algorithms. Users will also have new visualization tools that let them see heart beat average, PVC identification and tachogram.
The lack of proper data training for AI algorithms used for medical devices can end up being harmful to patients, experts told the FDA. The federal agency held a nearly seven-hour patient engagement meeting on the use of artificial intelligence in healthcare Oct. 22, in which experts addressed the public's questions about machine learning in medical devices. Experts and executives in the fields of medicine, regulations, technology and public health discussed the composition of the datasets that train AI-based medical devices. A lack of transparency surrounding the datasets that train algorithms can lead to public mistrust in AI-powered medical tools, as these devices may not have been trained using patient data that accurately represents the individuals they will be treating. During the meeting, Center for Devices and Radiological Health Director Jeffrey Shuren, MD, noted that 562 AI-powered medical devices have received FDA emergency use authorization and pointed out that all patients should be considered when these devices are being developed and regulated.
Our technology has advanced, our diagnostics have improved and our testing capability has advanced since the beginning of this pandemic, says Dr. Nicole Saphier, Fox News medical contributor. The Food and Drug Administration (FDA) warned about the possibility of false positives that can occur when using rapid antigen tests to detect coronavirus, particularly if the test is not used correctly. The regulatory agency said it has received reports of false-positive results occurring in nursing homes and other health care settings. The agency warned that reading the test results either before or after the specified time provided in the instructions can result in false-positive or false-negative results. It also referenced the antigen EUA conditions of authorization, which specifies that authorized laboratories are to follow the manufacturer's instructions for use regarding administering the test and reading the results.
At a virtual meeting of the U.S. Food and Drug Administration's Center for Devices and Radiological Health and Patient Engagement Advisory Committee on Thursday, regulators offered updates and new discussion around medical devices and decision support powered by artificial intelligence. One of the topics on the agenda was how to strike a balance between safety and innovation with algorithms getting smarter and better trained by the day. In his discussion of AI and machine learning validation, Bakul Patel, director of the FDA's recently-launched Digital Health Center of Excellence, said he sees huge breakthroughs on the horizon. "This new technology is going to help us get to a different place and a better place," said Patel. You're seeing automated image diagnostics.
While AI and machine learning have the potential for transforming healthcare, the technology has inherent biases that could negatively impact patient care, senior FDA officials and Philips' head of global software standards said at the meeting. Bakul Patel, director of FDA's new Digital Health Center of Excellence, acknowledged significant challenges to AI/ML adoption including bias and the lack of large, high-quality and well-curated datasets. "There are some constraints because of just location or the amount of information available and the cleanliness of the data might drive inherent bias. We don't want to set up a system and we would not want to figure out after the product is out in the market that it is missing a certain type of population or demographic or other other aspects that we would have accidentally not realized," Patel said. Pat Baird, Philips' head of global software standards, warned without proper context there will be "improper use" of AI/ML-based devices that provide "incorrect conclusions" provided as part of clinical decision support.
Scopio Labs, a leading provider of Full Field Morphology (FFM), announced that it was granted FDA clearance to market and sell its X100 with Full Field Peripheral Blood Smear (Full Field PBS) Application, unlocking the potential of in vitro hematology diagnosis. Full Field PBS is also available in Europe with CE mark certification granted earlier this year. Blood is one of the most foundational gateways to health information. Even with the adoption of digital tools, today's solutions do not showcase all required regions of interest in a PBS slide, only capturing snapshots of cells. To help improve diagnostic accuracy leveraging novel computer vision tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans using advanced computational photography imaging and tailored AI tools.
Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms for flagging and communicating incidental pulmonary embolism . Flagging incidental, critical findings is a huge technical challenge due to the varied imaging protocols used and lower incidences of such cases. The ability to prioritize incidental critical conditions accurately is a breakthrough in the value AI can bring to the radiologist workflow. "The most common use case we experienced is for critical unsuspected findings in oncology surveillance patients" said Dr. Cindy Kallman, Chief, Section of CT at Cedars-Sinai Medical Center. "The ability to call the referring physician while the patient is still in the house is huge. We are essentially offering a point-of-care diagnosis of PE for our outpatients. Our referring physicians have been completely wowed by this."