About PuRe™ Pupillometer
Solvemed's PuRe Pupillometer is a smartphone-based, FDA-regulated Class I medical device designed to modernize neurological assessment. Unlike traditional penlight exams that are subjective or hardware-based infrared pupillometers that are bulky and sensitive to environmental changes, this Software-as-a-Medical-Device (SaMD) solution uses the phone’s camera and advanced computational algorithms to measure pupil size and reactivity. Its primary purpose is to provide clinicians with objective, repeatable data that is vital for monitoring neurological status in critical care settings, allowing for faster and more accurate clinical decision-making at the bedside.
The tool features lighting-invariant technology, which ensures that measurements remain accurate regardless of ambient light conditions—a common point of failure for legacy hardware. It operates through the Solvemed mobile app, which utilizes secure authentication frameworks and high-resolution optical sensors to capture data. Information is processed in a SOC2- and HIPAA-compliant secure cloud, and the system can optionally integrate with major hospital Electronic Medical Record (EMR) systems like Epic, Oracle, and Meditech. This connectivity allows for instant data uploads, effectively reducing manual entry errors and streamlining documentation within the clinical workflow.
This tool is specifically designed for healthcare professionals working in high-stakes environments such as neuro-ICUs, trauma centers, stroke units, and emergency departments. It caters to physicians, nursing staff, and researchers who require standardized measurements to detect life-threatening complications like traumatic brain injuries. Because it resides on a smartphone, it eliminates the need for expensive, fragile hardware and the recurring costs of plastic disposables, making objective pupillometry more accessible and environmentally sustainable for hospitals of all sizes.
What sets the PuRe Pupillometer apart is its proprietary and open-source PuRe score. This score is specifically engineered to be immune to lighting changes by using exposure levels and initial pupil size to compute lighting-corrected parameters. While conventional tools often show significant variability when moving between dark and bright rooms, Solvemed’s approach maintains clinical reliability across varying environments. This focus on software-driven assessment rather than proprietary physical hardware makes it a cost-effective alternative for modernizing neurological monitoring capabilities.
PuRe™ Pupillometer FAQs
What makes the PuRe score different from standard pupillary measurements?
The PuRe score is designed to be immune to ambient lighting changes by using exposure levels to compute lighting-corrected parameters. This ensures that a patient's neurological status is not misinterpreted due to the brightness of the clinical environment.
Does this tool require specific proprietary hardware?
No, the PuRe Pupillometer is a software-based medical device that runs on a standard smartphone, eliminating the need for expensive standalone hardware. It utilizes the phone's built-in camera and secure authentication features like Face ID.
Can the data be synced with our hospital's existing records?
Yes, Solvemed Connect allows for full integration with major EMR systems like Epic, Oracle, and Meditech, typically within a 12-week timeframe. This allows for instant, secure uploads of pupil reactivity data directly to patient files.
Is the tool compliant with healthcare privacy regulations?
The system is both HIPAA- and SOC2-compliant, utilizing industry-standard cryptographic algorithms for data both at rest and in transit. It also features secure cloud processing to ensure patient data privacy is maintained at all times.
Are there any recurring costs for disposables like plastic eye cups?
No, a primary benefit of this solution is that it is free from disposables, such as the plastic eye cups required by conventional infrared pupillometers. This significantly reduces both operational costs and environmental impact.
