ArtemisDiana While artificial intelligence is a word heard in many industries, investors might be surprised that its use is growing in medical devices, diagnostics, and even drug development. Indeed, in 2022, the US FDA approved 91 AI or machine-learning enabled devices to its list of such approved devices. And since 1995, more than 500 AI-enabled devices have won FDA approval, according to Margaretta Colangelo, an AI consultant at Insilico Medicine. Three-quarters of the approved devices are for radiology. In other areas, 11% (57 devices) are in cardiology, while there are 15 and 14 devices, respectively, for hematology and neurology. A handful of devices each are for ophthalmic, gastroenterology/urology, and general and plastic surgery. Margaretta Colangelo/Insilico Medicine The company with the largest number of AI devices approved is GE Healthcare (GEHC) with 42. Coming at at No. 2 is Siemens Healthineers (OTCPK:SEMHF)(OTCPK:SMMNY) with 29. Philips (PHG) rounded out the top 5 with 10 devices. Among smaller companies in the AI medical device space is iRhythm Technologies (IRTC). The company won approval in July 2022 of its ZEUS System and accompanying Zio Watch. According to iRhythm, the watch “uses a continuous photoplethysmography, AI-based algorithm to detect [atrial fibrillation] and calculate an AFib burden estimate.” A report is then sent to the patient’s doctor. ZEUS and Zio were developed in collaboration with Verily Life Sciences, Alphabet’s (GOOG) life sciences research venture. Among larger medical device companies, Medtronic (NYSE:MDT) has several products on the approved products list. These include devices for continuous glucose monitoring (Guardian Connect), an electrocardiogram monitor (TruRhythm Detection), and colorectal cancer detection support (GI Genius). Large pharma AI partnerships It is important to note that many companies with approved AI products are smaller, privately held firms. These companies have tended to work with larger pharma companies. Two of note are Paige AI and PathAI. In June 2022, Paige AI announced a collaboration with Johnson & Johnson’s (NYSE:JNJ) Janssen unit for an AI-based biomarker test to screen for bladder cancer. Results will be available in less than an hour. PathAI has relationships with Bristol-Myers Squibb (NYSE:BMY), GlaxoSmithKline (NYSE:GSK), and Roche (OTCQX:RHHBY). In August 2022, the FDA approved the company’s digital pathology platform, AISight DX, for primary diagnosis in clinical settings. PathAI also has the AISight product for exploratory and clinical drug development research. Bristol (BMY) is using AISight to use AI-powered pathology for translational research in oncology, fibrosis, and immunology. Roche is using a new algorithm developed by PathAI in its digital pathology workflow software. And GSK (GSK) began a partnership in 2022 to use PathAI’s AIM-NASH tool to boost drug development programs in oncology and non-alcoholic steatohepatitis. AI to drive medical device innovation A recent report from analytics firm GlobalData argues that AI will become a significant driver of medical device innovation in 2023 as AI use among doctors also increases. The firm noted that the market for AI-based products will grow to $93 billion in 2023, up 12% from 2022. “We know that [AI] can be used for data management purposes, remote surgery, diagnostic and procedural assisting, clinical trials, and more,” said Alexandra Murdoch, a medical device analyst at GlobalData. The GlobalData report explains that AI can improve medical device manufacturing efficiency and reduce risk through machine learning. By analyzing vast amount of data, computers can learn from mistakes and make improvements. In addition, AI will likely influence digital health even more, benefitting patients. As an example, telehealth applications are using AI chatbots that take in and analyze a patient’s symptoms, and then provide health guidance.
