The living directory

PRODUCT DIRECTORY

Clinical-AI tools used in Australia, each with its TGA/ARTG status recorded as a documented fact — verifiable, cited, no verdicts.

89
clinical-AI tools tracked
35
ARTG-listed (TGA entry on file)
54
no ARTG entry found
0/24
ambient scribes on the ARTG

Facts only. "ARTG listed" means a current entry exists on the Australian Register of Therapeutic Goods (ID, sponsor and device class shown; verify each at tga.gov.au). "No ARTG entry" means our register check found none — note that most ambient-scribe and clinical-decision-support software is excluded from the ARTG by design, so an absence is expected and is not a safety or quality signal. We make no claim about any product's quality, safety or value. Inclusion is not endorsement. Data: Synvita digital-health register, 628 companies. Foreign-origin products are listed under their Australian sponsor.

ARTG listed a current TGA register entry exists  ·  No ARTG entry none found (often excluded software)

16 Bit

ARTG listed · 1 entr
Clinical AI · Other
X-ray image interpretive software (Rho osteoporosis AI; Physis bone age AI)
Class IIa · Sponsor LC & Partners Pty Ltd
ARTG 484559 · verify at tga.gov.au

Artrya

ARTG listed · 2 entr
Clinical AI · ANZ
Salix Coronary Anatomy AI software; X-ray image interpretive software
Sponsor Artrya Ltd; Artrya Pty Ltd
ARTG 518946 347719 · verify at tga.gov.au

CoTreat

ARTG listed · 1 entr
Clinical AI · ANZ
CoTreat AI clinical management support web-based application
Sponsor CoTreat Pty Ltd
ARTG 400152 · verify at tga.gov.au

Elekta

ARTG listed · 3 entr
Clinical AI · Europe
Radiation therapy treatment planning system application program software
Sponsor Elekta Pty Ltd
ARTG 413436 417496 377745 · verify at tga.gov.au

Eyetelligence

ARTG listed · 1 entr
Clinical AI · ANZ
Automated retinopathy analysis system application software
Sponsor Eyetelligence Pty Ltd
ARTG 355603 · verify at tga.gov.au

Neurosoft

ARTG listed · 1 entr
Clinical AI · Other
Poly-Spectrum-8/EX ECG interpretive multichannel electrocardiograph
Sponsor AIMedical International Pty Ltd
ARTG 433650 · verify at tga.gov.au

Persyst Development Corporation

ARTG listed · 1 entr
Clinical AI · US
Persyst EEG Review and Analysis Software
Sponsor MDSS AU Pty Ltd
ARTG 430739 · verify at tga.gov.au

Sydney Neuroimaging Analysis Centre

ARTG listed · 1 entr
Clinical AI · ANZ
iQ-Solutions quantitative MRI analysis software; Torana DICOM integration platform
Sponsor Sydney Neuroimaging Analysis Centre Pty Ltd
ARTG 456068 · verify at tga.gov.au

TheraPanacea

ARTG listed · 2 entr
Clinical AI · Europe
AccuCheck - Radiation therapy treatment planning system application program software; Adaptivo - Radiation therapy treat
Sponsor Oxford Scientific Pty Ltd
ARTG 461686 311096 · verify at tga.gov.au

Varian Medical Systems

ARTG listed · 1 entr
Clinical AI · US
Radiation therapy treatment planning system application program software
Sponsor Varian Medical Systems Australasia Pty Ltd
ARTG 332540 · verify at tga.gov.au

4D Medical

ARTG listed · 3 entr
Diagnostics AI · ANZ
X-ray image interpretive software; X-ray system diagnostic computed tomography application program software
Class Class IIa · Sponsor 4D Medical Limited
ARTG 510810 433171 344948 · verify at tga.gov.au

Aidoc

ARTG listed · 1 entr
Diagnostics AI · US
aiOS (operating platform); BriefCase (triage modules); Aidoc Revenue Cycle
Class Class I · Sponsor ACRA Regulatory Services Pty Ltd
ARTG 316044 · verify at tga.gov.au

Caristo Diagnostics

ARTG listed · 1 entr
Diagnostics AI · UK
CaRi-Heart - Clinical management support web-based application software
Class Class IIa · Sponsor Emergo Asia Pacific Pty Ltd T/a Emergo Australia
ARTG 375486 · verify at tga.gov.au

FEops

ARTG listed · 1 entr
Diagnostics AI · Europe
Radiology DICOM image processing application software
Class Class 1 · Sponsor Emergo Asia Pacific Pty Ltd T/a Emergo Australia
ARTG 351533 · verify at tga.gov.au

Franklin.ai

ARTG listed · 1 entr
Diagnostics AI · ANZ
Franklin.ai (AI digital pathology analysis platform)
Class Class 4 IVD (Interpretive software IVD) · Sponsor Franklin-AI Pty Ltd

Gleamer

ARTG listed · 1 entr
Diagnostics AI · Europe
X-ray image interpretive software
Class Class IIa · Sponsor Emergo Asia Pacific Pty Ltd T/a Emergo Australia
ARTG 396751 · verify at tga.gov.au

Harrison.ai

ARTG listed · 3 entr
Diagnostics AI · ANZ
Annalise.ai (AI chest X-ray and radiology analysis platform); Franklin.ai (AI digital pathology — separate subsidiary)
Class Class 1 · Class IIb · Sponsor Annalise-AI Pty Ltd
ARTG 343577 513346 454945 · verify at tga.gov.au

MIM Software

ARTG listed · 1 entr
Diagnostics AI · US
Radiology picture archiving and communication system application software
Class IIa · Sponsor NL-Tec Pty Ltd
ARTG 481927 · verify at tga.gov.au

Mindways Software

ARTG listed · 2 entr
Diagnostics AI · US
QCT PRO - X-ray system diagnostic computed tomography application program software; X-ray system diagnostic bone absorpt
Sponsor Mindways Australia Pty Ltd
ARTG 471145 202317 · verify at tga.gov.au

MyCardium AI

ARTG listed · 1 entr
Diagnostics AI · UK
Computer application program software cardiac physiology
Class Class IIb · Sponsor MedEnvoy Global Pty Ltd
ARTG 512405 · verify at tga.gov.au

Omniscient Neurotechnology

ARTG listed · 1 entr
Diagnostics AI · ANZ
Radiology DICOM image processing application software
Class Class IIa · Sponsor Omniscient Neurotechnology Pty Ltd
ARTG 399163 · verify at tga.gov.au

Philips

ARTG listed · 4 entr
Diagnostics AI · Europe
Medical image management system application software; Radiology DICOM image processing application software; X-ray syste
Class Class IIa · IIa · Sponsor Philips Electronics Australia Ltd
ARTG 244353 399710 406620 462325 · verify at tga.gov.au

Siemens Healthineers

ARTG listed · 6 entr
Diagnostics AI · Europe
Diagnostic digital imaging system workstation application software; MRI system application program software; Radiology D
Class Class IIa · Class IIb · Sponsor Siemens Healthcare Pty Ltd
ARTG 410851 277754 399398 381133 373073 399232 · verify at tga.gov.au

Therenva

ARTG listed · 1 entr
Diagnostics AI · Europe
Therenva Endonaut System - Radiology DICOM image processing application software
Class Class IIb · Sponsor Neutron X-Ray & Imaging Systems Pty Ltd
ARTG 413610 · verify at tga.gov.au

United Imaging Healthcare

ARTG listed · 1 entr
Diagnostics AI · Other
Radiology DICOM image processing application software
Class Class IIa · Sponsor United Imaging Healthcare (Australia & New Zealand) Pty Ltd
ARTG 296386 · verify at tga.gov.au

VectraCor

ARTG listed · 1 entr
Diagnostics AI · US
Interpretive multichannel electrocardiograph
Class Class IIb · Sponsor The Trustee for Pacific Medical Trust
ARTG 525496 · verify at tga.gov.au

AIQ Australia

ARTG listed · 1 entr
Imaging / PACS · ANZ
Radiology picture archiving and communication system application software
Class IIa · Sponsor AIQ Australia Pty Ltd
ARTG 402321 · verify at tga.gov.au

Apollo Medical Imaging Technology

ARTG listed · 1 entr
Imaging / PACS · ANZ
MIStar radiology PACS/advanced image analysis software; AutoMIStar PACS
Class IIa · Sponsor Apollo Medical Imaging Technology Pty Ltd
ARTG 328170 · verify at tga.gov.au

ARO Systems

ARTG listed · 1 entr
Imaging / PACS · ANZ
iQ-System PACS
Sponsor ARO Systems Pty Ltd
ARTG 408910 · verify at tga.gov.au

Canon Medical Systems

ARTG listed · 1 entr
Imaging / PACS · Other
Radiology picture archiving and communication system application software
Class IIa · Sponsor Canon Medical Systems ANZ Pty Ltd
ARTG 419210 · verify at tga.gov.au

Healthinc

ARTG listed · 1 entr
Imaging / PACS · ANZ
Radiology PACS application software (JiveX Enterprise PACS; Veolity AI)
Class IIa · Sponsor Healthinc Pty Ltd
ARTG 471525 · verify at tga.gov.au

Hologic

ARTG listed · 1 entr
Imaging / PACS · US
X-ray image interpretive software (mammography AI)
Sponsor Hologic (Australia & New Zealand) Pty Ltd
ARTG 464965 · verify at tga.gov.au

Intellirad Solutions

ARTG listed · 1 entr
Imaging / PACS · ANZ
Voyager PACS; Voyager Cloud PACS
Sponsor Intellirad Solutions Pty Ltd
ARTG 344752 · verify at tga.gov.au

Optos

ARTG listed · 1 entr
Ophthal AI · UK
Ophthalmology PACS software
Sponsor Optos Australia Pty Ltd
ARTG 488625 · verify at tga.gov.au

alphaXRT

ARTG listed · 1 entr
Radiotherapy · ANZ
Radiation therapy treatment planning system application program software
Sponsor alphaXRT Pty Ltd
ARTG 430253 · verify at tga.gov.au

33n (CLEARnotes)

No ARTG entry
Ambient Scribe · UK
CLEARnotes
No ARTG entry found in our register check.

Abridge

No ARTG entry
Ambient Scribe · US
Abridge (ambient AI scribe); Contextual Reasoning Engine
No ARTG entry found in our register check.

Ambience Healthcare

No ARTG entry
Ambient Scribe · US
AutoScribe (ambient documentation); AutoCDI (coding/CDI); AutoAVS (after-visit summaries); AutoRefer (referral automatio
No ARTG entry found in our register check.

Anathem

No ARTG entry
Ambient Scribe · UK
Anathem
No ARTG entry found in our register check.

Aprobrium (Lexacom)

No ARTG entry
Ambient Scribe · UK
Lexacom Echo; Lexacom 3
No ARTG entry found in our register check.

Beam Up

No ARTG entry
Ambient Scribe · UK
Magic Notes; Magic Reports
No ARTG entry found in our register check.

CLAI Ltd

No ARTG entry
Ambient Scribe · UK
CLAI
No ARTG entry found in our register check.

Corti

No ARTG entry
Ambient Scribe · Europe
Corti Scribe; Corti Assist; Corti Audit
No ARTG entry found in our register check.

DeepScribe

No ARTG entry
Ambient Scribe · US
DeepScribe (ambient AI scribe); DeepCode (AI medical coding)
No ARTG entry found in our register check.

Dictate IT

No ARTG entry
Ambient Scribe · UK
Augnito Omni (Dictate IT); SpeechReport
No ARTG entry found in our register check.

Docwise

No ARTG entry
Ambient Scribe · UK
Docwise AI Ambient Scribe
No ARTG entry found in our register check.

Eleos Health

No ARTG entry
Ambient Scribe · US
Eleos (ambient AI documentation for behavioural health); Insights (clinical quality analytics)
No ARTG entry found in our register check.

Freed

No ARTG entry
Ambient Scribe · US
Freed (ambient AI scribe and clinician assistant); SOAP note automation
No ARTG entry found in our register check.

HealthOrbit AI

No ARTG entry
Ambient Scribe · UK
MedOrbit; AI Voice Assistant
No ARTG entry found in our register check.

Heidi Health

No ARTG entry
Ambient Scribe · ANZ
Heidi Scribe (AI ambient clinical documentation); Heidi Evidence (AI-powered clinical decision support with HealthPathwa
No ARTG entry found in our register check.

Lyrebird Health

No ARTG entry
Ambient Scribe · ANZ
Lyrebird AI Scribe (ambient clinical documentation integrated with Best Practice EMR)
No ARTG entry found in our register check.

Nabla

No ARTG entry
Ambient Scribe · US
Nabla Copilot
No ARTG entry found in our register check.

Nuance (Microsoft DAX Copilot)

No ARTG entry
Ambient Scribe · US
DAX Copilot; Dragon Medical One; Dragon Ambient eXperience
No ARTG entry found in our register check.

Pungo/Joy

No ARTG entry
Ambient Scribe · UK
Joy
No ARTG entry found in our register check.

Scribetech (Augnito)

No ARTG entry
Ambient Scribe · Other
Augnito Spectra (speech-to-text); Augnito Omni (ambient AI scribe); Augnito Voice Services (API/SDK)
No ARTG entry found in our register check.

Suki

No ARTG entry
Ambient Scribe · US
Suki Assistant
No ARTG entry found in our register check.

T-Pro

No ARTG entry
Ambient Scribe · Europe
T-Pro Dictate; T-Pro Copilot (ambient AI scribe); T-Pro Speech; eClinic Manager (virtual consultation)
No ARTG entry found in our register check.

Tandem Health

No ARTG entry
Ambient Scribe · Europe
Tandem Health Ambient Scribe
No ARTG entry found in our register check.

TORTUS

No ARTG entry
Ambient Scribe · UK
TORTUS AI Scribe; Surgery Intellect (via X-On)
No ARTG entry found in our register check.

Ada Health

No ARTG entry
Clinical AI · Europe
Ada (symptom assessment app); Ada API (B2B integration)
No ARTG entry found in our register check.

AlignMT AI

No ARTG entry
Clinical AI · US
AI Governance Platform (real-time AI risk monitoring and compliance SaaS)
No ARTG entry found in our register check.

Anima Health

No ARTG entry
Clinical AI · UK
Anima
No ARTG entry found in our register check.

Anterior

No ARTG entry
Clinical AI · US
Prior Authorization Solution (AI clinical review agents)
No ARTG entry found in our register check.

AutoMedica

No ARTG entry
Clinical AI · UK
SmartGuideline
No ARTG entry found in our register check.

Brellium

No ARTG entry
Clinical AI · US
AI Chart Auditing; MDM & E/M Coding; Clawback Protection; Automated Provider Training; Payor Audit Support
No ARTG entry found in our register check.

CodaMetrix

No ARTG entry
Clinical AI · US
CMX Autonomous Coding (AI-driven ICD/CPT code generation)
No ARTG entry found in our register check.

Cohere Health

No ARTG entry
Clinical AI · US
Cohere Unify (PA platform); Cohere Align (smart waiver/green-lighting); Cohere Connect (CMS compliance); Cohere Complete
No ARTG entry found in our register check.

Commure

No ARTG entry
Clinical AI · US
Commure Pro (clinical intelligence); Augmedix (ambient AI scribe); Strongline (staff safety/RTLS); Athelas Home (point-o
No ARTG entry found in our register check.

Healthily

No ARTG entry
Clinical AI · UK
Healthily Symptom Checker; Healthily API
No ARTG entry found in our register check.

Infermedica

No ARTG entry
Clinical AI · US
Symptom Checker API; Triage (patient intake); Infermedica Engine (clinical reasoning); Call Center AI
No ARTG entry found in our register check.

Klinik

No ARTG entry
Clinical AI · Europe
Klinik Access (online triage platform)
No ARTG entry found in our register check.

Limbic

No ARTG entry
Clinical AI · UK
Limbic Access; Limbic Care
No ARTG entry found in our register check.

OpenEvidence

No ARTG entry
Clinical AI · US
OpenEvidence (AI clinical search)
No ARTG entry found in our register check.

SmarterDx

No ARTG entry
Clinical AI · US
SmarterPrebill; SmarterDenials; SmarterUtilization; SmarterNotes; SmarterCharges
No ARTG entry found in our register check.

Glass Health

No ARTG entry
AI / CDS · US
Glass Health AI
No ARTG entry found in our register check.

Beamtree / ADI

No ARTG entry
AI coding · ANZ
Beamtree ADI
No ARTG entry found in our register check.

Brainomix

No ARTG entry
Diagnostics AI · UK
e-Stroke Suite; e-CTP; e-MRI
No ARTG entry found in our register check.

CardioScape

No ARTG entry
Diagnostics AI · ANZ
CardioScape platform (cardiac pathology digitisation and interactive clinical training)
No ARTG entry found in our register check.

DetectED-X

No ARTG entry
Diagnostics AI · ANZ
DetectED-X Platform (AI-assisted cancer screening detection and radiology training — breast and chest modules)
No ARTG entry found in our register check.

Healthy.io

No ARTG entry
Diagnostics AI · Other
Minuteful Kidney; Minuteful Wound
No ARTG entry found in our register check.

HeartFlow

No ARTG entry
Diagnostics AI · US
HeartFlow FFRCT Analysis
No ARTG entry found in our register check.

Kheiron Medical

No ARTG entry
Diagnostics AI · UK
Mia Reader; Mia IQ
No ARTG entry found in our register check.

Maxwell Plus

No ARTG entry
Diagnostics AI · ANZ
Maxwell (AI-powered clinical diagnostics platform — prostate cancer and Alzheimer's disease detection modules)
No ARTG entry found in our register check.

Optellum

No ARTG entry
Diagnostics AI · UK
Optellum Virtual Nodule Clinic
No ARTG entry found in our register check.

PocDoc

No ARTG entry
Diagnostics AI · UK
PocDocOS; Healthy Heart Check; HUESnap
No ARTG entry found in our register check.

Predictive Health Intelligence

No ARTG entry
Diagnostics AI · UK
hepatoSIGHT
No ARTG entry found in our register check.

Qure.ai

No ARTG entry
Diagnostics AI · Other
qXR; qER; qScout
No ARTG entry found in our register check.

Rad AI

No ARTG entry
Diagnostics AI · US
Omni Reporting; Omni Impressions; Omni Unchanged; Rad AI Continuity; Rad AI Nexus
No ARTG entry found in our register check.

Skin Analytics

No ARTG entry
Diagnostics AI · UK
DERM
No ARTG entry found in our register check.