521 FDA Authorized AI-Enabled Medical Devices

Since 1995, the FDA has authorized more than 500 AI-enabled medical devices via 510(k) clearance, granted De Novo request, or approved PMA. These AI based technologies are helping doctors detect malign changes such as tumors and hardening of the arteries and providing highly accurate measurements of organs and blood flow. AI algorithms have surpassed human performance in many medical imaging tasks and innovative companies have developed AI based tools to analyze radiology images and digital pathology images. AI-enabled devices have become invaluable decision making tools in medicine.

Today the FDA published an updated list that includes 178 new AI based devices that were authorized by the FDA through July 2022. In today's AI In Healthcare Milestones newsletter I'm sharing a high level analysis of the 521 devices on the list, charts to visualize the data, and a summary of milestones.

521 AI-Enabled Devices Across Medical Disciplines

Images: Margaretta Colangelo

521 Authorized Devices

• there are 521 devices on the FDA's updated list
• 448 of the devices are radiology and cardiology devices
• 75% are in radiology: 391 devices
• 11% are in cardiology: 57 devices
• 3% are in hematology: 15 devices
• 3% are in neurology: 14 devices

The following medical disciplines each make up 1% of the FDA cleared devices

• ophthalmic: 8 devices
• clinical chemistry: 6 devices
• gastroenterology & urology: 6 devices
• microbiology: 5 devices
• general and plastic surgery: 5 devices
• pathology: 4 devices
• anesthesiology: 4 devices
• general hospital: 3 devices
• obstetrics and gynecology: 1 device
• dental: 1 device

Companies With Multiple FDA Clearances

1. GE: 42 devices cleared
2. Siemens: 29 devices cleared
3. Canon: 17 devices cleared
4. Aidoc:?13 devices cleared
5. Philips: 10 devices cleared
6. Zebra Medical Vision: 9 devices cleared (acquired by Nanox Vision)?
7. Quantib: 7 devices cleared
8. Shanghai United Imaging Healthcare: 6 devices cleared
9. Viz.ai: 6 devices cleared
10. Arterys: 6 devices cleared (acquired by Tempus Labs)?

Note: According to the FDA their list is based on publicly available information and is not a comprehensive resource of approved AI/ML-enabled medical devices.

Historic Milestones For FDA Cleared AI-Enabled Devices

Arterys

In 2016 Arterys became the first AI company to receive?FDA clearance to use cloud-based deep learning in a?clinical setting. Prior to Arterys, nobody had developed a reliable, non-invasive, comprehensive diagnostic tool that enabled physicians to visualize and quantify blood flow for cardiovascular disease. The non-invasive standard of care was the echocardiogram, which was the first line of diagnosis but lacked blood flow accuracy. The alternatives to obtain more precise quantitative measures were expensive, time consuming, and invasive, and this data could not be read by legacy infrastructure. The cardiac application that Arterys developed reduced the time to process a case from?36 minutes to 6 minutes. Arterys’ cardiac application has already helped doctors treat more than 50,000 newborn babies with heart defects and is considered by doctors to be one of the top of AI solutions available. This week Arterys was acquired by Tempus Labs. Image Margaretta Colangelo

Paige

In September 2021 in a historic milestone, the FDA cleared Paige Prostate, the first?ever AI-based pathology product approved for clinical use.?Paige Prostate?is the first and only AI-based pathology product to receive FDA clearance for in vitro diagnostic use in detecting cancer in prostate biopsies. Paige compares tissue patterns in a prostate needle core biopsy to a large database of known cancers and provides information about matches to the pathologist to be used during the pathologist’s diagnosis. A study conducted by Paige showed that providing this additional information to pathologists during their diagnosis allows pathologists to reduce their false negatives by 70%, reduce their false positives by 24% and likely improve turnaround time of the results back to the urologist and patient. In June 2022 Paige?announced that in collaboration with Janssen they will deploy a new AI based biomarker test for advanced bladder cancer in a clinical setting. This marks a major milestone in the deployment of Janssen’s AI technology in a clinical setting to efficiently detect biomarkers. With this new AI based biomarker test, patients will have their results in less than one hour.?Image Margaretta Colangelo

PathAI

On August 12, 2022 the FDA cleared PathAI's AISight Dx?digital pathology platform for primary diagnosis in clinical settings. AISight Dx was designed using input from hundreds of external pathologists in laboratories worldwide as well as from staff at PathAI Diagnostics, PathAI’s anatomic pathology lab. AISight Dx is a standalone viewer that can interoperate with existing manual and digital pathology workflows and can enable pathologists who are working remotely to collaborate seamlessly to drive fast turnaround times for patients. PathAI has also developed?AISight?to support AI-driven research at biopharma companies, contract researchers, and academic institutions. Researchers engaged in exploratory and clinical drug development research can leverage this platform specifically for regulated clinical trials or translational research. PathAI is collaborating with Bristol Myers Squibb to expand the use of these machine learning models. Roche is integrating a novel algorithm developed by PathAI into its digital pathology workflow software and GlaxoSmithKline is leveraging PathAI’s technologies in digital pathology including the use of PathAI’s AIM-NASH tool.?Cleveland Clinic’s is combining PathAI’s AI-based platforms with its clinical expertise and multi-modal data to unlock a broad implementation of next-generation pathology diagnostics. Image Margaretta Colangelo

Gleamer

In March 2022 the FDA cleared Gleamer's BoneView? AI software to detect fractures and traumatic skeletal injuries in the US. This is the first solution to receive FDA and CE clearance in this category. In a recent study BoneView?helped hospitals reduce missed fractures by 29% and increased sensitivity by 30% for exams with more than one fracture. In the study published by?Boston University School of Medicine, BoneView was shown to help detect and localize fractures over the entire appendicular skeleton, rib cage, thoracic and lumbar spine, improving sensitivity and specificity, while reducing reading time.?BoneView received the CE mark class 2a certification in the European Union in?March 2020?and has been widely adopted in more than 300 institutions across 13 countries. In July 2022 Fujifilm integrated Gleamer BoneView AI software into its world class x-ray systems. Results are available within 30 seconds at the point of care, providing healthcare workers with additional support to help improve patient care. Image Margaretta Colangelo

Rune Labs

In June 2022 the FDA cleared?Rune Labs' StrivePD App?for the Apple Watch. The StrivePD mobile app is used by people who have Parkinson's disease to monitor and collect symptom data. The app uses motion sensors in Apple’s Movement Disorder API (that are already built into the Apple Watch) to monitor involuntary movements and tremors. This FDA 510(k) clearance will expand the reach of Rune Labs' platform to millions of people who have Parkinson's and people at risk of developing Parkinson's. Having the app cleared for use on Apple Watch is significant because it expands clinical care and trial participation for tens of thousands of people with Parkinson's who already use the Apple Watch. Image Margaretta Colangelo

Aidoc

In April 2022 Aidoc received FDA-clearance for an AI algorithm for triage and notification of brain aneurysm. Aidoc now has 13 FDA cleared devices. In 2018 the company was granted FDA clearance for an algorithm to flag acute intracranial hemorrhage in CT?scans, and in 2019 the company received FDA clearance for its?pulmonary embolism?system. Aidoc has also obtained?FDA clearance for algorithms to detect pneumothorax,?stroke, cervical fracture,?intra-abdominal free gas, and?incidental pulmonary embolism. Aidoc's AI based decision support software analyzes medical imaging data, flags findings, and alerts radiologists, surgeons, and neurologists of suspected positive cases. In May 2022 Aidoc and Gleamer partnered to expand the use of AI in medical imaging. In June 2022 Aidoc raises $110 million in Series D expansion round and in July 2022 Aidoc formed a strategic partnership with Isala Hospital in The Netherlands to implement AI at scale in radiology. Isala will integrate 3 of 10 AI algorithms in Aidoc’s suite of CE-marked and FDA-cleared AI solutions for triage and notification of intracranial hemorrhage, pulmonary embolism, and c-spine fractures. Image Margaretta Colangelo

AZMed

In June 2022 the FDA cleared?AZMed's Rayvolve deep learning tool to identify fractures on x-rays. In a clinical study Rayvolve reduced medical errors by 20% and decreased review and interpretation time by 27%. AZMed has established 78 partnerships with university hospitals, radiology centers, and clinics. Its AI solutions are used in over 300 hospitals and clinics in 21 countries in the US, Europe, and Africa and more than 2,500 radiologists and emergency physicians have integrated the AI software into their workflow as a part of their in clinical routine. Image Margaretta Colangelo

iSono Health

In May 2022 the FDA cleared iSono Health's AI driven ATUSA? System for breast imaging. This is the world's first AI-driven portable and automated 3D breast ultrasound scanner. In just 2 minutes, the ATUSA system automatically scans the entire breast volume, independent of operator expertise, and offers 3D visualization of the breast tissue. The ATUSA system is designed from the ground up to seamlessly integrate with advanced machine learning models that will give physicians a comprehensive set of tools for decision making and patient management.

Note: All images in this newsletter were created by Margaretta Colangelo. If you use them you must include a citation acknowledging that Margaretta Colangelo is the source of the images and provide a link to this newsletter.

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Copyright ? 2022 Margaretta Colangelo. All Rights Reserved.

This article was written by?Margaretta Colangelo.?Margaretta is a leading AI analyst who tracks significant milestones in AI in healthcare. She's consulting at AI healthcare companies and she writes about some of the companies she's consulting with. Margaretta serves on the advisory board of the AI Precision Health Institute at the University of Hawai?i?Cancer Center?@realmargaretta