Ascent Cardiorespiratory Diagnostic Software
Medical Graphics CorporationAscent Cardiorespiratory Diagnostic Software is a standalone application used with hardware to measure, collect, and analyze lung and cardiopulmonary function tests. It helps clinicians, such as pulmonologists and cardiologists, diagnose lung and heart-related conditions by processing test data from devices like spirometers and body plethysmographs. The software provides detailed pulmonary and cardiopulmonary metrics, manages diagnostic data, and facilitates interpretation and reporting, improving diagnostic workflow.
Intended Use
Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, and cardiopulmonary testing (CPET) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The results can be viewed online, printed, saved, and used for referral or report generation. The software is used under physician supervision in hospital or clinical settings.
Technology
Software functions as a stand-alone application compatible with various hardware devices (e.g., spirometers, body plethysmographs) to collect physiological data for pulmonary and cardiopulmonary testing. It includes data integration, quality checks, visualization, and report generation. The software supports spirometry, plethysmography, bronchial challenge, CPET with breath-by-breath gas analysis, indirect calorimetry, and other related tests. Communication with hardware is via USB. Testing standards from ATS, ERS, ACCP are followed, and cybersecurity considerations are included.
Performance
The software underwent extensive validation with system-level, performance, and safety testing per relevant medical device software standards (ISO 14971, IEC 62304, FDA guidances). Performance validation included key pulmonary function parameters (FEV1, MVV, FRC, DLCO, VO2, VCO2 etc.). Cybersecurity was addressed. Clinical performance was demonstrated to be substantially equivalent to predicate devices. Relevant guidelines from ATS/ERS/ACCP were used for acceptability and repeatability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/17/2024
1 month - 2
FDA Approval
10/17/2024
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