FDA
Taking the guesswork out of dental care with artificial intelligence
When you picture a hospital radiologist, you might think of a specialist who sits in a dark room and spends hours poring over X-rays to make diagnoses. Contrast that with your dentist, who in addition to interpreting X-rays must also perform surgery, manage staff, communicate with patients, and run their business. When dentists analyze X-rays, they do so in bright rooms and on computers that aren't specialized for radiology, often with the patient sitting right next to them. Is it any wonder, then, that dentists given the same X-ray might propose different treatments? "Dentists are doing a great job given all the things they have to deal with," says Wardah Inam SM '13, Ph.D. '16.
Taking the guesswork out of dental care with artificial intelligence
When you picture a hospital radiologist, you might think of a specialist who sits in a dark room and spends hours poring over X-rays to make diagnoses. Contrast that with your dentist, who in addition to interpreting X-rays must also perform surgery, manage staff, communicate with patients, and run their business. When dentists analyze X-rays, they do so in bright rooms and on computers that aren't specialized for radiology, often with the patient sitting right next to them. Is it any wonder, then, that dentists given the same X-ray might propose different treatments? "Dentists are doing a great job given all the things they have to deal with," says Wardah Inam SM '13, PhD '16.
Artificial Intelligence Briefing: CFPB Weighs in on Algorithmic Transparency
Consumer Financial Protection Bureau (CFPB) issues policy statement on credit decisions based on complex algorithms. On May 26, the CFPB issued Circular 2022-03, which addresses an important question about algorithmic decision-making: "When creditors make credit decisions based on complex algorithms that prevent creditors from accurately identifying the specific reasons for denying credit or taking other adverse actions, do these creditors need to comply with the Equal Credit Opportunity Act's requirement to provide a statement of specific reasons to applicants against whom adverse action is taken?" The Circular says yes, compliance with ECOA and Regulation B is required even if complex algorithms (including AI and machine learning) make it difficult to accurately identify the specific reasons for taking the adverse action. Further, the Circular makes clear that those laws "do not permit creditors to use complex algorithms when doing so means they cannot provide the specific and accurate reasons for adverse actions." White House executive order calls for study of predictive algorithms used by law enforcement agencies.
Aidoc raises $110M to expand AI-enabled imaging platform
AI-enabled imaging company Aidoc scooped up $110 million in a Series D funding round. The round was led by TCV and Alpha Intelligence Capital with participation from AIC's co-investor CDIB Capital. The investment, which comes nearly a year after the startup announced its $66 million Series C, brings Aidoc's funding pot to $250 million. Aidoc offers tools that help radiologists find and triage injuries and health conditions based on imaging results. It also provides coordination software for stroke and cardiovascular care, alerting relevant members of the care team and sharing data and images.
Aidoc Raises $110 Million In Series D Expansion Round
This week Aidoc announced that they have raised $110 million in their Series D expansion round. This round of funding was co-led by TCV and Alpha Intelligence Capital with participation from CDIB Capital. Funding raised in this round will go toward expansion of Aidoc's first of its kind AI Care Platform. The platform offers health systems a singular platform solution designed to help doctors manage the entire patient lifecycle--from diagnostic aid, to consultation, to suggested treatment paths, to patient follow-up tools. In clinical studies, this platform has proven to reduce turnaround time, shorten patient length of stay and improve patient outcomes.
Lunit Files Registration Statement for Initial Public Offering
First Korean healthcare company to obtain "AA-AA" ratings in technology assessment for its FDA-cleared and CE-marked solutions Lunit intends to list its common stock on the KOSDAQ market under the ticker code "A32813". NH Investment & Securities will act as book-running manager, backing Lunit's debut. A total of 1,124,300 shares will be offered in the price range of KRW 44,000 to 49,000 ($34-38). The exact price will be determined after recording the demand of institutional investors on July 7-8, while retail buyers can take part in the public subscription during July 12-13. Based on the low end of the targeted range, Lunit expects to raise about KRW 54 billion ($42 million).
Policy Brief
As the development and adoption of AI-enabled healthcare continue to accelerate, regulators and researchers are beginning to confront oversight concerns in the clinical evaluation process that could yield negative consequences on patient health if left unchecked. Since 2015, the United States Food and Drug Administration (FDA) has evaluated and granted clearance for over 100 AI-based medical devices using a fairly rudimentary evaluation process that is in dire need of improvement as these evaluations have not been adapted to address the unique concerns surrounding AI. This brief examined this evaluation process and analyzed how devices were evaluated before approval. We analyzed public records for all 130 FDA-approved medical AI devices between January 2015 and December 2020 and observed significant variety and limitations in test-data rigor and what developers considered appropriate clinical evaluation. When we performed an analysis of a well-established diagnostic task (pneumothorax, or collapsed lung) using three sets of training data, the level of error exhibited between white and Black patients increased dramatically.
Algorithms in Medicine: Where They Help … and Where They Don't
Walter Bradley Center director Robert J. Marks continued his podcast discussion with anesthesiologist Richard Hurley in "Good and bad algorithms in the practice of medicine" (May 19, 2022). An algorithm is "a procedure for solving a mathematical problem (as of finding the greatest common divisor) in a finite number of steps that frequently involves repetition of an operation." Algorithms, Dr. Marks points out, can either sharpen or derail services, depending on their content. Before we get started: Note: Robert J. Marks, a Distinguished Professor of Computer and Electrical Engineering, Engineering at Baylor University, has a new book, coming out Non-Computable You (June, 2022), on the need for realism in another area as well -- the capabilities of artificial intelligence. This portion begins at 01:59 min.