Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

INTRODUCTION — As technology advances, medical devices are more frequently relying upon software incorporating artificial intelligence (AI). Specifically, machine-learning is generating real world evidence from the delivery of health care, which in turn is becoming integrated into emerging medical devices.

However, regulatory approval and oversight of these devices is necessary. The US Food and Drug Administration (FDA) has granted regulatory approval to a number of machine learning-enabled medical devices and has published them in a publicly available list [1]. These devices are included in the sections below, including a description of each device excerpted and edited from the FDA approval documentation. Additional sources have also been referenced in creation of this list of FDA approved devices [2].

Critically, inclusion of a given device on this list does not indicate UpToDate endorsement of its use. Please refer to UpToDate content on relevant clinical issues for information on the UpToDate approach to diagnosis, monitoring, and management.

CARDIOLOGY

Arrhythmias

●DeepRhythmAI – The DeepRhythmAI (DRAI) software is used to detect arrhythmias and automatically analyze electrocardiograms (ECG) [3]. DRAI is a cloud-based AI algorithm that analyzes all the heart beats in the processed ECG signal and based on that classifies them as either correct or arrhythmic.

●Verily Study Watch with irregular pulse monitor – The Study Watch is a miniature wearable device that continuously monitors the ECG and heart rate, among other data [4,5].

●Zeus system Zio watch – The Zio Watch Service is used in adults with atrial fibrillation (AF) or susceptibility to AF to analyze the ECG and photoplethysmogram, in order to detect AF [6].

●Apple Watch atrial fibrillation history feature – The AFib History Feature analyzes pulse rate data from the Apple watch to identify irregular heart rhythms suggestive of AF, and provides an estimate of the time spent in AF [7,8]. It includes a medical app on the Apple Watch as well as one on the iPhone.

●Apple IRNF app – The Irregular Rhythm Notification Feature is a medical application that analyzes pulse rate data from the Apple Watch and notifies the wearer if AF is present [9,10].

●AliveCor KardiaMobile 6L and AliveCor QT – KardiaMobile 6L is a device to obtain an ECG, which clinicians can use to manually measure their patients' QT interval [11,12]. AliveCor QT Service is cloud-based software that provides clinicians with the heart-rate corrected QT.

●Implicity IM007 – IM007 records and analyzes ECG data from Insertable Cardiac Monitors (ICM) to help diagnose arrhythmias [13].

●LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System – The LINQ II ICM is an insertable device that records ECG [14,15]. It can be activated by the patient or can be automatically activated. It is used in adults with risk for or symptoms of arrhythmias.

●Zio ECG Utilization Software and AT ECG Monitoring System, Zeus System – The Zio ECG Utilization Software and AT ECG Monitoring System process ECG data from compatible monitoring devices, allowing for detection of arrhythmias (either automatically or via analysis of patient triggered events) [16-19]. After data collection, a report is generated for clinician review. These devices are used in patients at risk for or with symptoms of an arrhythmia.

●VX1 – The VX1 is a machine learning software that helps providers identify intracardiac atrial electrograms exhibiting spatiotemporal dispersion during an ablation procedure for AF [20,21].

●RX-1 Rhythm Express Remote Cardiac Monitoring System – The Rhythm Express is a remote cardiac monitoring system [22]. The device connects to standard ECG electrodes to capture two channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting the electrocardiogram. It can function in one of three modes: mobile cardiac telemetry, event recorder, and wireless Holter, and can be worn by patients for up to two weeks.

●BodyGuardian Remote Monitoring System – The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients [23]. The device makes use of commercially-available, external plug-in devices such as ECG sensors, blood pressure meters, and pulse oximeters.

●AI-ECG Tracker – The AI-ECG Tracker uses machine learning to assess ambulatory ECG data to identify arrhythmias in adults without pacemakers [24]. The interpretations by the analysis program can be confirmed, edited, modified, or deleted by qualified clinicians.

●AI-ECG Platform – The AI-ECG Platform uses machine learning to assist clinicians in the interpretation of a 12-lead resting ECG. The interpretation by the analysis program may then be confirmed, edited, or deleted by qualified clinicians [25].

●Eko Analysis Software – The Eko Analysis Software assists in the evaluation of patients' heart sounds and ECG [26]. The software detects suspected murmurs as well as AF and normal sinus rhythm. It can also calculate heart rate, QRS duration, and electromechanical activation time. It does not identify arrhythmias other than AF and does not identify the type of murmur.

●PhysIQ Heart Rhythm and Respiratory Module – The physIQ Heart Rhythm and Respiration Module is used to calculate heart rate and heart rate variability, to detect AF, and to determine respiration rate by automated analysis of ambulatory ECG data and triaxial accelerometers [27,28].

●Loop System – The Loop System records arterial oxygen saturation, heart rate, and respiratory rate in adult patients in the home environment. This data is subsequently transmitted to a web server for remote review by a clinician [29,30].

●KardiaAI – KardiaAI is a software analysis library that assists in the assessment of ECG rhythms (eg, normal sinus rhythm, AF, bradycardia, and tachycardia) in ambulatory electrocardiograms recorded from a variety of devices including event recorders [31,32].

●RhythmAnalytics – RhythmAnalytics is a software that assesses for cardiac arrhythmias using single-lead ECG data; clinicians should review and confirm the analytic result [33].

●Rx-1 Rhythm Express Remote Cardiac Monitoring System – The Rhythm Express remote cardiac monitoring system provides continuous monitoring of ECG, functioning in one of three modes: mobile cardiac telemetry, event recorder, and wireless Holter [34].

●Cardio-TriTest v6.5 – The Cardio-TriTest v6.5 combines the results from a 12-lead ECG, a 4-lead phonocardiograph, and a 4-lead mechanocardiograph into a contiguous presentation that aids in diagnostic interpretation by a clinician [35].

●FibriCheck – FibriCheck can be used by patients to self-monitor for AF on an intermittent basis [36].

●Rooti Rx ECG Event Recorder, Rooti Link APP Software – Rooti Rx System allows an outpatient to record a single-lead ECG for review by their health care provider [37,38].

●Peerbridge Cor(TM) System – The Peerbridge Cor System is a wearable monitoring device that captures and transmits symptomatic events and continuous ECG data for 24 hours and up to seven days and provides the data to the clinician for review [39].

●CardioLogs ECG Analysis Platform – The CardioLogs ECG Analysis Platform analyzes data that is recorded from compatible devices used for the arrhythmia diagnostics (eg, Holter, event recorder) [40,41]. It can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems.

●Reveal LINQ – A Reveal LINQ insertable cardiac monitor is a small device placed under the skin that continuously monitors heart rhythm for up to three years [42-44].

●FEops HEARTguide – FEops HEARTguide performs computer simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning [45-48]. It predicts implant frame deformation to guide LAAO device size and placement.

Hemodynamics (vital signs monitoring)

●Gili Pro Biosensor (also known as Gili Biosensor System) – The Gili Pro BioSensor includes an optical module that captures motion-vibration signals from an illuminated surface to collect data such as heart and respiratory rate [49,50].

●Oxehealth Vital Signs – The Oxehealth Vital Signs device is software that analyzes video footage to estimate a subject's heart and respiratory rate when the patient is stationary [51,52]. It is indicated for use in a hospital room, or in other secured environments that require a trained professional to perform periodic checks on a patient. It is not appropriate for the critical care setting or in those needing continuous vital sign monitoring.

●Analytic for Hemodynamic Instability (AHI) – The AHI software is used in adults receiving continuous ECG monitoring [53,54]. AHI uses the ECG to characterize the patient's hemodynamic status and identify signs of hemodynamic instability.

●CLEWICU System (ClewICUserver and ClewICUnitor) – CLEWICU is used in the intensive care unit (ICU) to predict a patient's likelihood of future hemodynamic instability [55-58].

●PeraMobile, PeraWatch, PeraServer, PeraTrend – These devices are used to track, monitor, and display the Rothman Index (RI) within a hospital setting. The RI uses aggregates vital signs, laboratory values, and nursing assessments to produce a single score that reflects the patient's mortality risk [59,60].

●Biovitals Analytics (BA) Engine – The BA Engine is used with continuous health data collected from sensors that monitor heart rate, respiratory rate, and activity in ambulatory patients either in a health care facility or at home, during times of minimal activity [61,62]. The device calculates a time series Biovitals Index (BI), which is a reflection of the difference between a patient's measured vital signs and their previous baseline values.

●Edwards Lifesciences Acumen Hypotension Prediction Index and Software – The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the probability that a patient will have a future hypotensive event [63,64]. It is used in patients receiving advanced hemodynamic monitoring, in conjunction with other clinical information. The device consists of software paired with an extravascular blood pressure transducer and a radial arterial catheter. It is used in patients receiving advanced hemodynamic monitoring, in conjunction with other clinical information.

●WAVE Clinical Platform – The WAVE Clinical Platform is software that manages and displays information from multiple sources including medical devices, Electronic Medical Records, and Clinical Information Systems [65]. It is a remote monitoring platform that displays physiologic data, waveforms, alarms, results, and diagnostic information routed through the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital or hospital-type environments.

●Tyto Stethoscope – The Tyto Stethoscope is an electronic stethoscope that allows for a clinician in one location to hear the auscultation sounds of a patient on site or at a different location on the IP network [66,67]. It allows four types of exams: heart, lungs, heart rate, and audio.

●Personalized Physiology Analytics Engine Software – The PhysIQ Personalized Physiology Analytics Engine ("PPA Engine") is a computerized analysis software program that is designed for detecting change in the relationships among the patient's vital signs throughout dynamic physical activity [68], based on data input from multi-parameter vital sign monitoring devices.

●Visensia – Visensia with alert is a software accessary to patient monitors (bedside or ambulatory) and clinical information systems and is used in adult patients in whom multiparameter patient monitoring is needed [69,70].

Heart sounds

●Eko Murmur Analysis Software (EMAS) – EMAS allows users to upload phonocardiograms and ECG signals and provides the clinician with an analysis and decision support regarding the patient's heart sounds [71].

●eMurmur Heart AI – The 'eMurmur Heart AI' software provides an automated analysis of recorded heart sounds from a digital stethoscope and identifies S1, S2, physiologic heart murmurs, pathologic heart murmurs, and the absence of a heart murmur [72,73].

●eMurmur ID – The eMurmur ID software system records, displays, and analyzes heart sounds recorded by an electronic stethoscope, and identifies S1, S2, physiologic heart murmurs, pathologic heart murmurs and absence of a heart murmur [74].

●Stethee Pro 1, Stethee Pro Software System – The Stethee Pro 1 is an electronic stethoscope that is used to detect, record, and amplify sounds from the heart, lungs, arteries, veins, and other internal organs [75]. With the Stethee Pro Software System data can be analyzed and shared with other authorized users.

●Steth IO – The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is used to detect and amplify sounds from the heart and lungs with the use of selective frequency ranges [76].

Coronary artery disease

●DEEPVESSEL FFR (DVFFR) – DEEPVESSEL FFR is simulation software that provides an analysis of separately-acquired Computed Tomography Digital Imaging and Communications in Medicine (CT DICOM) data in patients with symptomatic but clinically stable coronary artery disease (CAD) [77,78].

●HeartFlow Analysis – The HeartFlow Analysis is simulation software that provides analysis of CT DICOM data to assess the anatomy and function of the coronary arteries [56-58].

●FFRangio – CathWorks FFRangio is a software that provides analysis of separately-acquired angiography DICOM data for patients with CAD [79-81]. FFRangio analysis assesses coronary artery anatomy and function, and supports the evaluation of CAD. It retrieves standard angiographic images on which the user selects and marks the target lesion, ostium location, main vessel, target vessel, and other key features.

●HeartfFow FFRCT Analysis – HeartFlow Analysis is simulation software that analyzes separately-acquired CT DICOM data for symptomatic but clinically stable patients with CAD [56-58,82]. FFRCT analysis assess coronary artery anatomy and function, thereby supporting the evaluation of CAD. There is also a version 2.0 [83].

Heart failure

●SOZO – The SOZO Fluid Status Monitor provides noninvasive monitoring of patients heart failure and fluid management problems to assist their clinician in management [84,85].

ENDOCRINOLOGY

Diabetes

●DreaMed Advisor Pro – DreaMed Advisor Pro is software that provides recommendations for the adjustment of insulin for patients who have type 1 diabetes and are using an insulin pump and continuous glucose monitoring [86].

●One Drop Blood Glucose Monitoring System – The One Drop Blood Glucose Monitoring System measures blood glucose levels from blood samples drawn from the fingertip [87].

●Dario Blood Glucose Monitoring System – The Dario Blood Glucose Monitoring System measures blood glucose levels [88]. The Dario App displays the results in real time and also provides alerts and reminders.

●WellDoc BlueStar – The WellDoc BlueStar System securely captures and transmits blood glucose data to assist patients and their health care providers in diabetes management [89,90]. It also provides motivational and educational coaching messages based on blood glucose values and trends to promote medication adherence.

●D-Nav System – The d-Nav System is a software-based, prescription-only product designed to provide the next insulin dose recommendation as an aid for personal insulin management [91,92].

●EndoTool SubQ – EndoTool SubQ is software that makes recommendations to the health care provider regarding an individual patient's next dose of subcutaneous insulin [93].

GASTROENTEROLOGY

Colonic polyps

●EndoScreener – The EndoScreener uses input from the colonoscopy video and provides computer-assisted detection of colorectal polyps in real time [94].

●GI Genius – The GI Genius System is used in patients undergoing white-light endoscopy and provides computer-assisted detection of colonic mucosal lesions (eg, polyps and adenomas) in real time [95].

Other endoscopic findings

●NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System – The NvisionVLE Imaging System evaluates and provides an image of tissue microstructure, using two-dimensional, cross-sectional, and real-time depth visualization [96].

GENETICS

●23andMe Personal Genome Service (PGS) Genetic Health Risk Test – The 23andMe PGS Test uses qualitative genotyping to detect variants in the DNA that suggest health risks for specific conditions [97]. These include:

•Hereditary thrombophilia

•Alpha-1 antitrypsin deficiency

•Late-onset Alzheimer's Disease

•Parkinson's Disease

•Gaucher Disease Type 1

•Factor XI deficiency

•Celiac disease

•Glucose-6-phosphate-dehydrogenase deficiency

•Hereditary hemochromatosis

•Early-onset primary dystonia

NEPHROLOGY

Urinalysis

●Minuteful - kidney test – The Minuteful - kidney test is a kit and smartphone application that measures and displays albumin and creatinine in urine, along with the albumin-creatinine ratio [98].

●ACR | LAB Urine Analysis Test System – The ACR | LAB Urine Analysis Test System is a kit (including a color board and reagent strips) along with a smartphone application that measures albumin and creatinine in urine and displays the results, along with the albumin-creatinine ratio [99].

●DIP/U.S. Urine Analysis Test System – The DIP/U.S. Urine Analysis Test System is a kit (including a color board and reagent strips) along with a smartphone application that measures urine parameters including pH, glucose, protein, specific gravity, blood, and nitrate and provides these results directly to the clinician to aid in the diagnosis and monitoring of kidney disease [100].

NEUROLOGY

Traumatic brain injury and concussion

●BrainScope TBI – BrainScope TBI is a portable device that provides a multiparameter assessment based on the patient's electroencephalogram, cognitive exam, and clinical symptoms in order to aid in the diagnosis of concussion (mild traumatic brain injury) [101].

●EyeBOX – The EyeBOX analyzes eye movements as an aid in the diagnosis of concussion in conjunction with a standard neurologic assessment [102,103].

Upper limb prosthetics

●Myo Plus – Myo Plus is used as the control unit for exoprosthetic fittings of the upper limbs; it measures electromyographic signals and assigns them to the movements of the prosthesis [104,105]. Through calibration using the Myo Plus App, the control unit assigns muscle signals to various types of movement of the prosthesis.

●COMPLETE CONTROL System Gen2 – The COMPLETE CONTROL System Gen2 is used as the control unit for external prosthetic fittings of the upper limbs [106]. It employs pattern recognition technology to acquire muscle signals for the control of the upper extremity prostheses.

●Sense System with IBT Electrodes – The Sense System is a surface electromyography electrode system designed to enhance control of upper limb prosthetic devices [107].

Seizure

●Embrace – The Embrace is a device that provides an adjunct to seizure monitoring in home or health care facilities [103,108]. The device senses electrodermal activity and motion data and detects patterns potentially associated with generalized tonic clonic seizures. When a seizure event is identified, a paired wireless device will initiate an alert to a designated caregiver. The data is stored for subsequent review by the clinician.

●Persyst 14 EEG Review And Analysis Software – Persyst 14 EEG Review and Analysis Software assists in the review of ambulatory electroencephalography (EEG) data [109-111].

OBSTETRICS AND GYNECOLOGY

In vitro fertilization

●KIDScore D3 – The KIDScore D3 tool predicts of likelihood of embryos' development by scoring them according to their statistical viability [112]. If multiple embryos appear suitable for transfer or freezing, the tool provides additional information to assist in the embryo selection for either transfer, freezing, or continued development.

OPHTHALMOLOGY

Diabetic retinopathy

●Idx-DR v2.3 – Idx-DR is used with Topcon NW400 to automatically detect (more than mild) diabetic retinopathy in the eyes of adults with diabetes who have not been previously diagnosed with diabetic retinopathy [94,113-118].

●EyeArt – EyeArt automatically detects (more than mild) diabetic retinopathy as well as more severe diabetic retinopathy in eyes of adults with diabetes who have not been previously diagnosed with diabetic retinopathy [119-121].

Other diseases in the retina and ocular surface

●CLARUS – The CLARUS model 700 is an active, software imaging device that captures, displays, stores, and annotates images of the eye to assist in the diagnosis and monitoring of diseases affecting the ocular surface, retina, and visible adnexa [122,123].

●IRIS Intelligent Retinal Imaging System – The IRIS software is a service application that allows clinicians to scan a patient's retina with a fundus camera, upload the images to a website and provide an interpretation of the scans [124,125].

Visual tracking impairment

●RightEye Vision System – The RightEye Vision System views, records, and analyzes eye movements in patients who may have impairments of visual tracking [126,127].

PEDIATRICS

Autism spectrum disorder

●EarliPoint System – The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of autism spectrum disorder (ASD) in patients ages 16 months through 30 months [128,129]. EarliPoint Device with eye-tracking capability captures the patient visual response to social information provided in the form of a series of age appropriate videos.

●Cognoa Autism Spectrum Disorder Diagnosis Aid – The Cognoa ASD Diagnosis Aid uses a machine-learning algorithm that integrates information from caregivers and clinicians to assist in diagnosing ASD [130]. It comprises of both software applications and hardware platforms. Users input data via a mobile app, a video analyst portal, and/or a health care provider portal.

PULMONOLOGY AND SLEEP MEDICINE

Spirometry

●Air Next – Air Next is a hand-held spirometer that measures parameters such as the forced expiratory volume in 1 sec and the forced vital capacity for use in assessing and monitoring disease that affect lung function (eg, cystic fibrosis, asthma, chronic obstructive pulmonary disease) [131-136].

Sleep

●Compumedics Sleep Monitoring System – The Compumedics Sleep Monitoring System assists in diagnosing of sleep disorders [137] by integrating the recording of electroencephalography, electrocardiograms, respiratory and body position sensors, and oximeters.

●MATRx Plus – MATRx Plus assists in the assessment of sleep disordered breathing in the home setting [138,139] by recording respiratory nasal flow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.

●SnoreSounds – SnoreSounds is a smartphone app to diagnose obstructive sleep apnea [140]. The software analyzes snoring quantitatively and qualitatively.

●EnsoSleep – EnsoSleep assesses sleep parameters in order to identify respiratory related sleep disorders [141]. Along with the stage of sleep, the devices detects arousals, leg movements, and breathing events such as obstructive apneas, central sleep apneas, and hypopneas.

SURGERY

Wound healing

●SpectralMD DeepView Wound Imaging System 2.0 – The SpectralMD DeepView Wound Imaging System provides images of blood flow in the microcirculation and provides an assessment of perfusion of both healthy and injured skin (eg, skin flaps, chronic wounds, decubitus ulcers, diabetic ulcers, and burns) [142].

●MIMOSA Imager – The MIMOSA Imager is used in the ambulatory care setting to estimate the spatial distribution of percent oxygen saturation in tissue during the examination of patients with suspected circulatory compromise [143].

Margin evaluation

●OTIS 2.1 Optical Coherence Tomography System, ThiA Optical Coherence Tomography System – The Perimeter OTIS 2.1 images excised tissue using optical coherence tomography, in order to visualize intraoperative margins [144].

Laparoscopy

●TransEnterix Senhance Surgical System – The Senhance Surgical System is used in a variety of laparoscopic surgeries to assist in controlling laparoscopic instruments, both for visualization as well as for endoscopic manipulations such as grasping, cutting, dissecting, electrocautery, and suturing [145-148].

Estimation of blood loss

●Triton System – The Triton System is a software application used on an Apple iPad that captures images of used surgical sponges in order to estimate blood loss and to assist operating room personnel in the management of surgical sponges after surgical use [149,150].

Intraoperative monitoring

●NuVasive Pulse System – The Pulse NVM5 provides intraoperative neurophysiologic monitoring during neck dissections, spinal and thoracic surgeries, and surgeries of the upper and lower extremities [151].

Stereotactic image guidance

●7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application – The 7D Surgical System is a stereotactic image guidance system to assist in spatial positioning of neurosurgical instruments [152,153].

SUMMARY

●Inclusion of a given device in this topic does not indicate UpToDate endorsement of its use.

●Medical devices are more frequently relying upon software incorporating artificial intelligence (AI).

●The list includes devices enabled by AI/machine learning that have been approved by the US Food and Drug Administration (FDA) approval.

●Please refer to UpToDate content on relevant clinical issues for information on the UpToDate approach to diagnosis, monitoring, and management.