BrightInsight Announces the Launch of a CE-marked Dosing Calculator for Emicizumab
May 23 2019 - 8:00AM
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.
ABOUT BRIGHTINSIGHT, A FLEX COMPANY
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190523005110/en/
Media & PressLewis Farrell1 (650)
485-9912lewis.farrell@brightinsight.com
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