Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
The European Union (EU) is steadily making progress on the Artificial Intelligence Act (AI Act), landmark legislation that will affect AI not just for medical uses, but for all uses across the EU economy.
Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said.
Kakao Healthcare Corp. launched an artificial intelligence (AI)-powered mobile application called PASTA on Feb. 1 for continuous glucose monitoring (CGM)-based diabetes care. PASTA pairs with two types of CGM sensors, either from Seoul-based I-sens Inc.’s Caresens Air or San Diego-based Dexcom Inc.’s G7 system.
To date, developers of digital health technologies have had little luck with coverage and reimbursement, but the picture is slowly improving. The U.K.’s National Institute for Health and Care Excellence (NICE) has endorsed two artificial intelligence (AI) algorithms for diagnosis of stroke, although this is limited to an evidence generation framework that puts the sponsors on the hook for generating the data that will allow unlimited use in the U.K.’s trusts.
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.
A team of inventors predominantly based in the state of New York are seeking patent protection for an earbud system that integrates real-time electroencephalography (EEG) monitoring with audio playback. Using specialized silicone electrodes, it captures and interprets EEG data, serving as a passive and continuous tool for screening neurological conditions.
Quibim SL recently launched its artificial intelligence (AI)-based software QP-Brain, which is designed to detect early-stage neurodegenerative diseases, after it received U.S. FDA 510(k) clearance, as well as CE and UKCA marks from the EU and U.K. regulators, respectively. QP-Brain quantifies and presents data from patients’ brain images to help clinicians with early diagnosis and treatment strategies for diseases such as Alzheimer’s, multiple sclerosis and dementia.
The first patenting from Mhealthcare Inc. describes a patient examination table or bed equipped with a variety of sensors, data from which may be analyzed with trained machine learning models to facilitate risk assessment and diagnosis of non-neurotypical developmental conditions such as autism in infants and young children by predicting cognitive, behavioral, social and developmental outcomes as early as the first three months of life. It is also claimed that the table may be used to diagnose epilepsy and Alzheimer’s disease.
The U.S. FDA might still be seen as the premier med tech regulatory entity in the world, but the agency is badly outnumbered by companies in the life sciences, which are pumping out artificial intelligence algorithms at a breathtaking pace. Further, the FDA must also avoid being lapped by industry in connection with the regulatory novelty known as the predetermined change control plan, a challenge that put the agency’s device center in scramble mode for essentially the entirety of calendar year 2023.
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