Australia - englanti - Department of Health (Therapeutic Goods Administration)

eyetelligence pty ltd - 58713 - automated retinopathy analysis system application software - the eyetelligence advanced vision is a software as a service product based on computer vision and natural language processing technology. this product intends to automatically provide information on the imaging modalities that used to generate the image and screen for diseases that is most consistent with the features of the images and the pathologic lesions existed in the image. the eyetelligence system outcomes are intended to be subsequently verified and certified by a qualified medical/eye care professional who will make a clinical decision based on a range of inputs not limited to eyetelligence outcomes.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

siggie pty ltd - 61087 - clinical management support web-based application software - siggie software is a clinical management support software application that may be accessed by digital devices, both online (web based) and offline (application software). the software assists patients and their clinicians to efficiently complete clinical mental health diagnostic assessments by simplifying the collection, analysis and interpretation of mental health data the software: 1. assists patients to provide relevant data by responding to specific questions 2. assists clinicians to review and refine this data by responding to specific questions 3. assists patients and clinicians to work together to analyse, interpret and refine this data in order to generate: - a provisional diagnosis (if applicable) which requires validation by the clinician (and whenever possible) by the patient - a provisional evidence-based treatment plan informed by the provisional diagnosis and relevant clinical practice guidelines, which also requires validation by the clinician (and whenever possible) by the patient 4. assists the patient and clinician to work together to monitor the patient's response to treatment utilising diagnostic tools and outcome measures siggie is designed to compliment and enhance (not replace) the patient / clinician relationship by assisting them to efficiently navigate the diagnostic assessment and management process. all data inputs and outputs require validation by the patient and the clinician, and the clinician retains clinical autonomy with the ability to override and/or modify any clinical recommendations. siggie digitalises the content and logic contained in: - the psychiatric clinical diagnostic assessment - the dsm-5 and icd-10/11 mental health diagnostic classification systems - up to date evidence-based clinical practice guidelines for the treatment of mental disorders - relevant mental health literature this information is in the public domain and can be readily accessed by patients and clinicians, both online and in paper form eg. through public libraries

Australia - englanti - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 43958 - patient monitor, cardiac, foetal - the device is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (fhr), uterine activity (ua) and maternal heart rate (mhr). the device acquires and displays the fhr tracing from abdominal surface electrodes that pick up the fetal ecg (fecg) signal. using the same surface electrodes, the device also acquires and displays the ua tracing from the uterine electromyography (emg) signal and the mhr tracing from the maternal ecg signal (mecg). the device is indicated for use on women who are at >36 completed weeks (37.0), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. the interface is an accessory to the device which provides a means of interfacing the wireless output of the device to the transducer inputs of a ctg fetal monitor. the device enables signals collected by the device to be printed and displayed on a ctg fetal monitor and sent on to a central network, if connected. the device is a maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

ascom integrated wireless pty ltd - 40573 - alarm, software - the unite connect for clinical systems acquires alarms, events, parameters and waveform data from bedside medical equipment and clinical systems using validated device drivers. processes alarms and data using configurable filters and assignment algorithms that determine which information is delivered to which users, and forwards these as notifications to designated display devices. operating environment: windows server os & standard off the shelf server hardware. supported sources: inputs from bedside medical equipment and clinical systems utilizing validated drivers for open and proprietary protocols.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

sonic equipment australia pty ltd - 41185 - audiometer, automatic-recording - intended to measure the signal presentations, frequency selection or variation, hearing level variation, and the recording of the subject's responses are implemented automatically. the direction of hearing level changes is under the subject's control. an automatic recording audiometer may have facilities for presenting fixed frequencies or a continuously variable/sweep frequency, or both. it may also provide both continuous and pulsed tone outputs.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 47812 - intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator - the neurx ra/4 external pulse generator is a component of synapse biomedical's neurx diaphragm pacing system and is an external four channel, battery powered device that controls the stimulus output and respiratory timing. the four output channels are independently controlled, capacitively coupled, biphasic outputs with a common return. a programming connector is located in the battery compartment for connection to the clinical station. the device has no controls that allow modification to any parameter settings. on-off power control consists of redundant switches that require actuation at the same time to provide protection from accidental actuation by incidental contact.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

getz healthcare pty ltd - 14292 - urinary catheterization/collection kit - used to obtain accurate urine outputs form neonatal and pediatric patients.

Singapore - englanti - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - ramipril - tablet - 2.5 mg - ramipril 2.5 mg

Singapore - englanti - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - ramipril - tablet - 5 mg - ramipril 5 mg

Singapore - englanti - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - clobazam - tablet - 10 mg - clobazam 10 mg