Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Jubilant DraxImage Receives FDA Approval for Ruby-Fill Rubidium 82 Generator and Elution System

October 4, 2016 By Jubilant DraxImage Inc.

Jubilant DraxImage Inc., a wholly owned subsidiary of Jubilant Pharma Ltd, announced that the U.S. Food and Drug Administration has approved Ruby-Fill, an innovative technology for Positron Emission Tomography (PET) myocardial perfusion imaging (MPI).

Comprised of a Rubidium-82 (Rb-82) generator and precedent setting elution system, Ruby-Fill is used to produce a personalized patient dose of Rubidium Rb 82 chloride used to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease (CAD), which is an important component of diagnosing CAD.

“We are proud to bring to the U.S. market a groundbreaking, state-of-the-art technology for myocardial perfusion imaging. Ruby-Fill expands DraxImage’s nuclear medicine portfolio and is a part of our commitment to provide healthcare providers and their patients with innovative health care solutions for those with suspected or existing coronary artery disease,” comments GP Singh, CEO of Jubilant Pharma Ltd.

“Our knowledge of the role and value of PET nuclear cardiology, specifically Rb-82 Chloride PET in known or suspected coronary artery disease, advanced significantly as we progressed through the comprehensive and rigorous FDA review process,” said Norman LaFrance, M.D., chief medical officer and senior VP, medical & regulatory affairs for Jubilant Pharma and Jubilant DraxImage. “With its advanced weight based dose accuracy and multiple infusion options, among other product capabilities, Ruby-Fill will enhance the way patients with known or suspected coronary artery disease are both diagnosed and managed.”

Commercial launch plans for Ruby-Fill is expected to be in the October-December 2016 quarter.

The Rubidium elution system has been exclusively designed to be used with the Ruby-Fill generator and to deliver accurate doses of Rb-82 Chloride to patients. (Credit: Jubilant DraxImage Inc. at http://www.draximage.com/en/pipeline/cardiovascular-pet.html)

Ruby-Fill Rubidium 82 Generator and Ruby Rubidium Elution System

The Ruby-Fill generator contains an accelerator produced Strontium-82, which decays to Rubidium-82. When the generator is eluted with saline it produces a sterile, non-pyrogenic solution of Rb-82 Chloride.

Due to the short half-life (75 s) of Rb-82, the use of an elution system is required for delivery of the Rb-82 Chloride into a patient for the purposes of performing Myocardial Perfusion Imaging with PET. PET imaging with Rb-82 Chloride may be performed under rest and/or stress conditions.

The Rubidium Elution System has been exclusively designed to be used with the Ruby-Fill generator and to deliver accurate doses of Rb-82 Chloride to patients.

For more information: Medical and regulatory affairs medicalaffairs@jdi.jubl.com; http://www.draximage.com/en/pipeline/cardiovascular-pet.html.

About Jubilant DraxImage

Jubilant DraxImage Inc., a wholly owned subsidiary of Jubilant Pharma Ltd, which is held by Jubilant Life Sciences Ltd, develops, manufactures and commercializes radiopharmaceuticals used for the diagnosis and treatment of diseases. The company is dedicated to nuclear medicine and serves customers and through them patients, globally, with high quality and reliable products and services. www.draximage.com.

(Source: Business Wire)

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech