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InsightRX Receives CE Mark for Nova Software, Allowing it to Expand Precision Dosing Capabilities in Europe
New approval for precision dosing platform to improve patient care and outcomes in other parts of the world
SAN FRANCISCO, Aug. 5, 2021 /PRNewswire/ -- InsightRX, which provides a cloud-based precision dosing platform to help guide treatment decisions, announced today that its Nova platform has received a CE mark in six European countries: Austria, Belgium, France, Germany, the Netherlands, and the United Kingdom. CE mark approval paves the way for marketing and selling the Nova precision dosing software to these countries with the goal of helping providers individualize treatments and improve care quality for more patients.
The Nova precision dosing platform uses patient-specific data, pharmacokinetic/ pharmacodynamic (PK/PD) models, and Bayesian forecasting to understand a patient's unique pharmacological profile and guide treatment decisions. The Nova precision dosing platform, now available for commercial use in those six European countries, will contain the CE mark.
CE marking is a company's declaration that certain products meet applicable health, safety and environmental requirements, European product legislation, and have passed relevant conformity procedures. In addition to the CE mark, the Nova platform conforms to certain localization requirements for each of the European countries.
"We are committed to upholding the highest standards of quality and compliance to ensure our Nova platform is safe and effective," said Ranvir Mangat, Chief Operating Officer and co-founder at InsightRX. "For software-as-a-medical-device, there are unique challenges to analyze, verify, and validate software and mitigate potential risks while maintaining an agile development process. Now, with this CE mark, InsightRX has cleared requirements as a medical device with the EMA and UK regulatory authorities as well as implementing robust measures for cybersecurity and general data privacy and protection."
The InsightRX Nova precision dosing platform helps clinicians determine an optimal dose for patients in real time based on Bayesian forecasting. A real-time pharmacokinetic (PK) analysis is performed on each patient using InsightRX Nova, which considers patient demographics, population PK information, and therapeutic drug monitoring data to predict anticipated drug levels and help adjust and tailor the therapy for the patient.
"We are excited by InsightRX's new ability to market and deploy our precision dosing solutions in these European countries," said Sirj Goswami, CEO and co-founder of InsightRX. "Securing the CE mark helps us realize our vision where approved medications work effectively while drastically reducing side effects. We are actively engaging with and pursuing potential partners to make our best-in-class Nova platform broadly available for the benefit of patients in those countries."
The CE-marked Nova platform currently has a commercial contract with an academic medical center in the Netherlands, and several additional engagements currently in process. For more information about the Nova precision dosing platform, please visit InsightRX.
InsightRX is a healthcare technology company that has developed a cloud-based platform for precision medicine and clinical analytics designed to individualize treatment at the point of care. The platform leverages patient-specific data, pharmacology models, and machine learning to understand each patient's unique pharmacological profile and can be integrated seamlessly within a clinical workflow. InsightRX Nova has attained a CE mark in six European Countries, further demonstrating the company's dedication to quality, cybersecurity, and general privacy and data protection regulations. Learn more about InsightRX's recently announced $10 million Series A funding.
Amendola Communications for InsightRX