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G-Tech has developed a wearable medical technology used to measure gastrointestinal (GI) motility. The G-Tech system consists of wireless, wearable electrode patches that read electrical signals at the skin surface, a smartphone app that collects the raw data from the patches via BLE and sends it to a cloud server, and data analysis algorithms that process and quantify the motor activity of the digestive organs. They recently received their 510(k) clearance.
G-Tech came to Promenade for assistance with their Cybersecurity portion of the 510k submission. Promenade guided them through the design features and controls documentation and risk management, including the threat modeling and risk analysis. Our questionnaires and templates ensured that all aspects were covered and be as the auditor expects. A personal comment from the lead reviewer indicated that they were pleased with the care that had been put into the package which made their review easy!
SafeWorkDx enables fast, scalable workforce screening from worksite or from home through easy-to-administer saliva tests and CLIA validated diagnostic testing. Their clients use this system to test thousands of employees at the office or on the road. Interprise level clients have custom workflows and portals to fit their specific needs.
DxTerity also sells their kits via Walmart and Amazon. With our quick and efficient system, they were able to the first on Amazon!
Promenade Software built out Dxterity's cloud infrastructure for their multiple workflows. From the user portals providing patient or employer signup and result reporting, to interfacing to logistics to ship kits, payment systems, insurance, AIMs and more. Promenade Software was able to nimbly address the demands and allow Dxterity to be one of the early providers of PCR Covid tests.
The client was building a molecular detection system for oncology. This was a cartridge based system that had over 100 steps in the fluidics process, and required a software system that would allow for easy trial and data collection for precise system adjustments for the system developers and scientists. Precise control, adjustment of parameters, and visibility into the live sensor data was critical, as well as simple usability.
Promenade Software provided the software services and Parlay system for a complex cartridge based cancer detection system that had nearly 100 steps through the diagnostic flow process. Promenade Software supported their engineers through setting up Parlay and writing scripts to drive three m4 processors controlling the complex IO required for the system, including driving the motors, valves, solenoids and overall time-critical fluid flow.
“Designing a system with multiple embedded devices ‘from scratch’ can be a time consuming process. Communication protocol debug between sub-systems alone can take weeks or months to develop. With the Parlay embedded core, connecting multiple embedded devices is much more of a ‘plug and play’ environment for the developer. Subsystems can be connected together using various protocols to create a ‘distributed operating system’ of devices that the Parlay UI can discover and control”. Richard Maddox - Senior Electrical Engineer
G-Tech has developed a wearable medical technology used to measure gastrointestinal (GI) mobility. The G-Tech system consists of wireless, wearable electrode patches that read electrical signals at the skin surface, a smartphone app that collects the raw data from the patches via BLE and sends it to a cloud server, and data analysis algorithms that process and quantify the motor activity of the digestive organs. They recently received their 510(k) clearance.
"Promenade Software regulatory services were immensely helpful for us to understand and create the cybersecurity portion of our 510(k) submission. Their experts guided us through the documentation of the design features and controls and risk management, helping us create a robust threat model and risk analysis. With Promenade's assistance, the cybersecurity portion of our submission breezed through the FDA." - Anand Navalgund, PhD, Director of Clinical Science
SafeWorkDx enables fast, scalable workforce screening from worksite or from home through easy-to-administer saliva tests and CLIA validated diagnostic testing. Their clients use this system to test thousands of employees at the office or on the road. Interprise level clients have custom workflows and portals to fit their specific needs.
DxTerity also sells their kits via Walmart and Amazon. With our quick and efficient system, they were able to the first on Amazon!
Promenade Software built out Dxterity's cloud infrastructure for their multiple workflows. From the custom branded user portals providing patient or employer signup and result reporting, to interfacing with logistics to ship kits, payment systems, insurance, AIMs the project was complex. Promenade Software was able to nimbly address the demands and allow Dxterity to be one of the early providers of PCR Covid tests.
The client built a molecular detection system for oncology. This was a cartridge based system that had over 100 steps in the fluidics process, and required a software system that would allow for easy trial and data collection for precise system adjustments for the system developers and scientists. Precise control, adjustment of parameters, and visibility into the live sensor data was critical, as well as simple usability.
Promenade Software provided the software services and Parlay system for allowing their scientist with complete control of the flow and process, included several PCR phases and complex interactions with the system IO, fluidics and sensors. Promenade Software provided the firmware and supported their engineers through writing test scripts to drive multiple m4 processor boards controlling the complex IO required for the system. Our client quickly mastered the Parlay system and was able to prove out the concept.
“Designing a system with multiple embedded devices ‘from scratch’ can be a time consuming process. Communication protocol debug between sub-systems alone can take weeks or months to develop. With the Parlay embedded core, connecting multiple embedded devices is much more of a ‘plug and play’ environment for the developer. Subsystems can be connected together using various protocols to create a ‘distributed operating system’ of devices that the Parlay UI can discover and control”. Richard Maddox - Senior Electrical Engineer
