AI-enabled medical devices in the ARTG

Contour+ (MVision AI Segmentation) is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT and MR images using machine learning based algorithms.

The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows.
The system creates initial contours of pre-defined structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis.

Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.

Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyse and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities.

The data produced by this software is intended to be used to support qualified cardiologists, sonographers and radiologists to generate a report for review and approval by a qualified cardiologist with echocardiography subspecialty certification. Any generated report should not be used for clinical decision making before such review and approval. Us2.v2 is indicated for use in adult patients.

The subject devices are intended to be used for simulation and the planning of medical procedures.

The subject devices can be used to assist in the positioning of medical device components and to evaluate their size and delivery. The output can be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of orthopedic applications.

The subject devices should be used in conjunction with other diagnostic tools and expert clinical judgement.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of radiological images.

The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging and communication of suspected positive findings the following indications: 
1. Intracranial Hemorrhage (ICH) triage, non-enhanced head CT.
2. Cervical Spine Fracture (CSF) triage, non-enhanced cervical spine CT, bone kernel only.
3. Pulmonary Embolism (PE) triage, CTPA.
4. Vessel Occlusion (VO) triage, head CTA (VO on M1).
5. Intra-abdominal free gas (IFG) triage, abdomen CT. 
6. Incidental Pulmonary Embolism (iPE) triage, chest CT.
7. Rib Fracture (RibFx) triage, chest CT (with or without contrast).
8. Brain Aneurism (BA) triage, Head CTA.
9. Pulmonary Nodules (PN) QC, chest and abdomen CT (with and without contrast).
10. Pneumothorax (Ptx) triage, frontal chest X-Ray.
11. Vertically malpositioned endotracheal tube in relation to the carina (ETT)
12. Aortic Dissection (AD)
13. Vertebral Compression Fractures (VCFx)

BriefCase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on the user's professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiography for Aortic Dissection (AD).

CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) PE or (2) AD on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected PE or AD findings.

Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device.

The results of CINA CHEST are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

A software application intended to assist healthcare professionals assess patients at risk of coronary artery disease.

It processes CT images using artificial intelligence algorithms to detect and localise radiological findings.

The software is used as an adjunctive tool and is not intended as a replacement to a health professional's comprehensive review or their clinical judgment that considers other information from the CT images and the patient history.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic1 , fetal, abdominal, intraoperative (non neurological), pediatric, small organ, cephalic (adult), trans-rectal, transvaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.

The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

Clarius MSK AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 HD3 and L15 HD3). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment.

Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is indicated for use in adult patients only.

Clarius OB AI is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB AI is indicated for use in adult patients only.

Clarius Prostate AI is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and endo-cavitary scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Prostate AI is intended for use in adult male patients only.

Clarius Median Nerve AI is intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., linear array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Median Nerve AI is intended for use in adult patients only.

The HiRise is intended to be used for 3‐D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.

The device is to be operated in a professional healthcare environment by qualified health care professionals only.

The InReach is intended to be used for 3-D imaging of the hand, wrist, elbow, knee, foot, and ankle regions, to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures.

This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given hand, wrist, elbow, knee, foot or ankle condition is considered necessary.
* Patient parameters: 50lbs to 400lbs

The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures.

It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions.

This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs

*2D Imaging not intended for pediatric use.

DS Core CBCT Anatomy supports the viewing and analysing of X-ray images for the product DS Core Diagnosis by the detection of anatomical structures on 3D X-ray scans.

DS Core CBCT Anatomy constitutes supporting backend functionalities for the product DS Core Diagnosis.

The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The Cardiologs Resting Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias and structural abnormalities using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment the heart rhythm. The Cardiologs Holter Platform and Cardiologs Resting Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Holter Platform and Cardiologs Resting Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis. The Cardiologs Holter Platform and Cardiologs Resting Platform are not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs Holter Platform and Cardiologs Resting Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

inHEART Portal is an accessory of the following medical devices: inHEART Models Explorer and inHEART Models AI. It is a secured web platform for the management of customers' orders and the transfer of data between inHEART and its customers.

It allows customers to place and track orders, as well as to access online inHEART Models Explorer and to launch inHEART Models AI.

This web platform is intended to be used by qualified health professionals (including physicians, cardiologists, radiologists, and technicians) and inHEART staff (including Imaging analysts, sales representatives and Admins).

Preoperatively, it is intended to be used to assist with the planning of the procedure.

Intraoperatively, it is intended to be used to assist with the catheter navigation and with the identification of the arrhythmogenic substrate. Clinicians are solely responsible for making all final patient management decisions.

The device is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.

The device is also an electronic stethoscope that enables the recording and transmission of heart and lung auscultation sound data. The device is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages.

The device measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of atrial fibrillation or sinus rhythm on a classifiable ECG waveform. 
The device is also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (blood oxygen, or SpO2) and pulse rate (PR). It is indicated for use with individuals 18 years and older.

The companion app allows the device installation and displays the results of performed measurements.

The device is a medical device composed of software and the dedicated hardware of a reusable wrist applied device, which incorporates a single-lead electrocardiograph (ECG) and a reflectance photoplethysmograph (PPG). It is intended for intermittent measurements.

The device measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of AF or sinus rhythm on a classifiable ECG waveform.

The device measures, transfers, records and displays pulse rate to identify episodes of irregular heart rhythm suggestive of AF and provides a notification to the user. It can be used to supplement a clinician's decision to screen for possible AF.

The device is indicated for over-the-counter (OTC) use in adults.
The device is not recommended for users with other known arrhythmias.
The companion app allows the device installation and displays the results of performed measurements.

The Diagnocat AI automated information system is designed for cloud-based storage and processing of digital dental images using artificial intelligence. Diagnocat AI has been developed to automate the activities of dental organizations in radiological
examinations, including examination uploading, screening of diagnostic images, saving, sharing, editing and drawing conclusions.

Diagnocat AI processes files of any area of the patient's maxillofacial region. Diagnocat AI is designed for use by medical professionals (dentists, orthodontists, radiologists, etc.) for education purposes and highlights anatomical areas, common conditions, and previous treatments.

Diagnocat AI automatically produces radiological reports for easier viewing and documentation of investigation for a particular patient. Diagnocat AI can also be used by managers and administrators of clinics to document patient treatment history and maintain personal records.
This is a reusable, non-invasive device for image processing and documentation. The Software cannot be used to make a decision about the diagnosis, presence or absence of a disease on the basis of the online screening, without additional investigation.

The Software cannot be used for direct diagnosis and clinical decision making.

The Diagnocat AIS automated information system is designed for cloud-based storage and processing of digital dental images using artificial intelligence. Diagnocat AIS has been developed to automate the activities of dental organizations in radiological
examinations, including examination uploading, screening of diagnostic images, saving, sharing, editing and drawing conclusions. Diagnocat AIS processes files of any area of the patient's maxillofacial region. Diagnocat AIS is designed for use by medical
professionals (dentists, orthodontists, radiologists, etc.) for education purposes and highlights anatomical areas, common conditions and previous treatments.

DiagnocatAIS automatically produces radiological reports for easier viewing and documentation of investigation for a particular patient. Diagnocat AIS can also be used by managers and administrators of clinics to document patient treatment history and maintain personal records. This is a reusable, non-invasive device for image processing and documentation. The Software cannot be used to make a decision about the diagnosis, presence or absence of a disease on the basis of the online screening, without additional investigation.

The Software cannot be used for direct diagnosis and clinical decision making.

Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning.

Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios:

• Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning.
• Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy
  and archiving contours for patient follow-up.
• Localization and definition of healthy anatomical structures.

Limbus Contour is not intended for use with digital mammography.

This software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The software is an accessory to compatible general purpose diagnostic ultrasound systems. The software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients.

The EF feature is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.

Contour ProtégéAI is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.

Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Contour ProtégéAI is not intended to detect or contour lesions.

Align X-ray Insights is a computer aided detection ("CADe") software product that aids dental practitioners in the detection and analysis of dental radiographic image data for dental conditions for permanent dentition. The product is used in a professional dental practice environment by dental practitioners.

Align X-ray Insights analyzes bitewing, periapical, and panoramic radiographs using a set of artificial intelligence (AI)-based algorithms to assist in the detection of suspected radiographic abnormalities (caries, periapical radiolucencies, periodontal bone loss, and dental calculus), and other radiographic findings (dental fillings, dental crowns, dental implants, dental bridges, root-canal fillings, proximity of lower molars to mandibular canal, and impacted teeth). The classification and segmentation of teeth is used for tooth charting and reporting.

The results of Align X-ray Insights are intended to be used in conjunction with evaluation of other patient and clinical information including examination of radiographs as determined by the dentist's clinical standard of care and should not be solely relied upon to make or confirm a diagnosis.

The MyShoulder Planner software is intended for the processing of CT scan images and preoperative planning of the humeral and glenoid components of a total shoulder replacement in skeletally mature individuals who are candidates to receive a Medacta Shoulder System prosthesis.

The MyShoulder Planner software allows for taking preliminary decisions on implant size and positioning for a total shoulder replacement. The MyShoulder Planner software leads to the generation of one or more planning reports for each case.

Smilo is a smart device Application to provide oral health awareness. Smilo users upload images of their teeth and gums, which are processed by machine learning to produce an "Oral Health Rating" depending on the presence or absence of dental caries and periodontitis. Smilo does not provide a diagnosis. It provides dental awareness for users who are advised to visit a Dentist for further advice and treatment within clinically-recommended timeframes.

In addition to the Oral Health Rating function, the Application also provides:

• a "Dental Awareness and Education" function where articles on good oral health maintenance habits are regularly uploaded;
• a "Discussion Forum" where registered users may ask questions relating to oral health and the health professional administrators provide responses;
• a "Design my Smile" feature where an image of the user's smile is assessed by Artificial Intelligence and generates a picture of the user's optimal teeth and gum appearance with good oral health care and potentially maintenance through a registered Dentist.

Oral Health Ratings:
Green-Suggests your teeth and gums are in a stable- excellent condition. There is no or minimal probability of dental caries and periodontitis. Please watch and monitor your oral/dental health for any visible changes, pain, tenderness and if you notice any changes to the surface of your teeth or gums. You should still visit the dentist within 6-12 months from the date of your last visit.

Orange-Suggests that your teeth and gums need to be seen by a dentist. There is an above average probability of dental caries and/or gum disease. Please see the dentist as soon as possible to be investigated further.
Red-Suggests that your teeth and gums are in a poor state. There is a high probability of dental caries and gum disease. Please see your dentist urgently.

CARPL is a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools, imaging gateways. CARPL enables storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations.

CARPL offers the choice to incorporate third-party AI models that have been approved by the regulatory authority. CARPL solely aids in visualizing the outcomes of these third-party AI models without modifications. The safety and efficacy of the third-party models are governed by the regulatory approval granted to the original manufacturer of the said model. CARPL simply presents the simple AI response output, and the initial anonymized image remains consistently available.

This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.

The Sleep apnea feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.

This feature is intended to detect signs of moderate-to-severe obstructive sleep apnea in the form of significant breathing disruptions over a two-night monitoring period, for adult users 22 years or older. This feature is intended for on-demand use.

This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.

The product is intended to measure, review and store adults' ECG data at home or in healthcare environment, does not contain an auto-analysis function.

The ECG recorder is intended to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms at home or in healthcare environment. The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyse the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The device is intended for use by adults' health-conscious individuals. The product does not include analysis and diagnosis functions. The product has not been tested and it is not intended for paediatric use.

The Wireless dynamic multi-parameter holter is a small digital ambulatory ECG recorder. It is intended to record, store, display, transfer ECG data, receive and display blood oxygen (SpO2) and PR (pulse rate) data from the Pulse oximeter (SpO2 Probe); For routine checkups and/or self-monitoring of patients in the clinical setting and/or home settings under professional (e.g. doctor, nurse, family doctor) supervision.

Clinical setting is only applicable to the general medical clinical setting, not for ICU, Emergency, Intensive care, Surgery, and the clinical setting that must be specifically alarmed and analyzed.

The Wireless dynamic multi-parameter holter does not include analysis and diagnosis functions, does not include monitoring function. Data are given to the doctor or the user. The device no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.

The device data are used as a base to establish a doctors' diagnosis, but the data cannot replace the diagnosis result given by a doctor.

The Blood pressure monitor is intended to record, store, display and transfer single-channel electrocardiogram (ECG), blood pressure and pulse rate in adult population.

The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data (used under the care of a physician). The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.

The device is intended for use by adults' health-conscious individuals.
The device does not include analysis and diagnosis functions.

The device has not been tested and it is not intended for pediatric use.

The Dynamic ECG recorder is intended to measure, review and store adults' ECG data at home or in healthcare environment.

The device continuously records and stores ECG and activity data for at least 7 days at a time. The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.

The device does not include analysis and diagnosis functions. The device has not been tested and it is not intended for pediatric use.