Orthogonal, a Chicago-based medical device software company, is pleased to congratulate long-term client Nanowear on their recent FDA Class II 510(k) clearance for their flagship medical device, SimplECG™.
With this FDA approval, Nanowear has cleared a significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based nanosensors. While other companies have attempted to focus on wearable health care devices, few companies have pushed the boundaries as far as Nanowear.
Bernhard Kappe, Orthogonal’s CEO, said “Nanowear is the first company to provide both patient and physician-friendly mechanisms to facilitate the acquisition and management of health and diagnostic data through cloth-based nanosensor technology.”
With Nanowear’s proprietary nanosensor technologies, everyday undergarments — such as T-shirts and brassieres — can be designed to collect ECG, heart rate and respiratory data points and transmit them to physicians and clinicians using web and mobile apps; Bluetooth technologies; iOS smartphones; HIPAA-compliant databases; and, feature-rich clinical systems.
In discussing the market implications of innovations such as SimplECGO™, Kappe said, “this is precisely what a value-added healthcare economy needs: companies that leverage new technologies to extend the care continuum beyond the hospital and into the everyday lives of millions of Americans wrestling with heart disease and other ailments.”
As the medical software vendor tasked with capturing and transmitting diagnostic data, Orthogonal medical software engineers used Agile development processes to design and build robust integrated systems around the nanosensors. Engineers designed frameworks for storing and transmitting encrypted patient data to HIPAA-compliant mobile applications and to the cloud so that clinicians could securely access patient data.
“It is always exciting to see the medical validation of a startup vision. Nanowear’s team, although young, never wavered from their goal to create a best-in-class diagnostic tool based on unobtrusive undergarments. We are proud to have been a partner in the process.”
For more information, please visit www.nanowear.com.
At Orthogonal, we specialize in designing and building connected care systems that integrate medical devices, sensors and diagnostics with mobile applications, cloud computing and clinical systems. Our clients include medical device startups developing breakthrough therapies, innovative diagnostic tools and global monitoring solutions that use wearable sensors and implanted devices. Our clients also include industry leading enterprise organizations seeking to extend their market influence into combination medical devices that measurably improve health economic outcomes and position them to prosper in a value-based care environment. We offer full life-cycle medical software product design and development services using an Agile development process driven by mitigating cybersecurity breaches that serves to accelerate product introduction and to minimize risk.