Kal Patel, MD / May 23, 2019

BrightInsight Announces the Launch of a CE-Marked Dosing Calculator for Emicizumab

I am excited to share that BrightInsight announced earlier today the launch of a web-based CE-marked Dosing Calculator for emicizumab, a drug which is prescribed by physicians to treat patients with Hemophilia A. Hemophilia A is a rare disorder in which blood does not clot normally because it lacks sufficient blood-clotting proteins (clotting factors). The development and distribution of the Dosing Calculator for emicizumab is sponsored by F. Hoffmann-La Roche.

To support the usage of emicizumab, we launched this CE-marked Dosing Calculator to enable Health Care Professionals to input data to determine the correct dosage and number of vials for patients based on the approved recommended dosage.

The calculator aids physicians in determining the correct loading and maintenance dose of emicizumab that should be administered based on approved dosing recommendations and inputs of a patients’ biometrics. In addition, based on the same inputs, the Hemlibra Dosing Calculator also determines the recommended number of vial(s).

We built this Dosing Calculator under BrightInsight’s ISO 13485:2016 Certified QMS, which can support any classification of medical device (I – III), combination product or Software as a Medical Device (SaMD) in the US and Europe.

This is another great example of how our medical-grade Internet of Things (IoT) platform enables companies to easily build, deploy and globally scale regulated digital health solutions, including regulated medical apps, algorithms and connected drugs/devices.

You can hear more about how Roche & BrightInsight partnered to deploy a regulated digital health solution in this webinar.