Software consultation leads to positive FDA certification for critical cardiology tools

Usability Design

Product Testing

Analytics

Compliance Strategy

Led a comprehensive usability evaluation of 8 medical software products
Delivered a complete test plan, user testing, data analysis, and actionable recommendations
Enhance product safety and compliance of a cutting‑edge cardiology software tool central to clinical workflows.

Stellar helped the quantitative diagnostics group at Cedars-Sinai pass a regulatory review with the Federal Drug Administration (FDA) for one of its cardiology software programs. This software helps technicians and physicians analyze data from myocardial perfusion studies collected during PET and SPECT scans of the patient’s heart. The primary goal of the project was to identify potential hazardous use scenarios associated with the software and recommend mitigation strategies to help make the software safer and more effective.

Situation

Cedars-Sinai, one of the nation's top hospital systems, needed urgent support to pass an FDA regulatory review for a new cardiology software program. The software was designed to help physicians analyze data from myocardial perfusion studies—specialized heart imaging tests that show how well blood is flowing to the heart muscle. Facing a tight timeline, Cedars needed help quickly designing and executing a remote summative evaluation to identify potential hazards, recommend mitigation strategies, and ensure the software met FDA certification requirements.

Solution

Stellar partnered closely with Cedars-Sinai’s product engineers and subject matter experts to map real-world usage scenarios and pinpoint areas of potential risk. We developed a full test strategy, recruited and screened representative users, and conducted remote usability sessions that captured critical behavioral data. Over several weeks, we gathered and analyzed findings, delivering actionable insights and a complete set of documentation that helped Cedars strengthen the software’s safety profile.

Impact

Stellar conducted the testing of 8 software products, analyzed the results and presented Cedars-Sinai with a list of recommendations that helped them improve product safety and ace their 501(K) usability engineering review with the FDA. With Stellar’s support, Cedars-Sinai successfully ensured that their groundbreaking cardiology tools could continue helping patients without disruption.