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

SAN JOSE, Calif.–(BUSINESS WIRE)–BrightInsight announced 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, BrightInsight has launched a
CE-marked Dosing Calculator that will enable Health Care Professionals
to input data to determine the correct dosage and number of vials for
patients based on the approved recommended dosage. “This is a great
initiative for regulated digital health that provides a simple and
convenient solution for physicians,” said Kal Patel, MD, president &
chief executive officer, BrightInsight. “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. BrightInsight’s
Dosing Calculator helps to enable Health Care Practitioners prescribe
the correct dosage of emicizumab for people with Hemophilia A and
contributes to sustainable product use.”

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). BrightInsight built this
Dosing Calculator under its 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. The
Hemlibra Dosing Calculator is a CE-marked SaMD intended for use by
Health Care Professionals in Europe.


BrightInsight, a Flex Company, provides the leading global regulated
digital health platform for biopharma and medtech. Our medical-grade
Internet of Things (IoT) platform is built under a robust QMS ISO
13485:2016 to enable regulated drugs, devices and SaMDs to ingest and
analyze data and deploy regulated recommendations and insights back to
patients and providers. Additionally, the BrightInsight™ Platform
captures, transmits and analyzes data from CE-marked and FDA-regulated
medical devices, combination products, apps and Software as a Medical
Device, conforming with security, privacy and regulatory requirements
such as HITRUST and GDPR.


Media & Press
Lewis Farrell
1 (650) 485-9912
[email protected]

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