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
    • Subscribe to Print Magazine
    • 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

CoaguSense wins FDA clearance for monitoring system

April 5, 2019 By Danielle Kirsh

coagusense-logoCoaguSense (Fremont, Calif.) recently announced that it has received FDA 510(k) clearance for its second-generation prothrombin time/international normalized ratio (PT/INR) monitoring system.

The Coag-Sense PT2 meter is designed for monitoring patients who are on Coumadin. It features a clot-detection technology that is small enough to be carried in a lab coat pocket and connected wirelessly to a clinical network or a patient’s Bluetooth home monitoring application.

“We are committed to not only providing a very safe and accurate device to monitor blood coagulation levels, but also one that is simple to use and offers a variety of seamless wats to export the test results into virtually any data management system,” Douglas Patterson, president and CEO of CoaguSense, said in a press release. “The Coag-Sense PT2 meter is the result of the continuous innovation of a test system based on the same mechanical principle as the World Health Organization’s gold standard tilt-tube method and the research grade fibrometer.”

The device was cleared for professional use in CLIA-waived setting and patient self-testing at home. It offers built-in WiFi, Bluetooth, USB and wired Ethernet connectivity options. Patient and operator IDs are able to be captured while testing, allowing the device to be used with POCT data management systems like RALS or TELCOR QML without the need for a docking station. The meter can also store up to 2,000 test results and 500 QC results.

Related Articles Read More >

Connected device design for the real world: Managing the development process
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
Rockley Photonics
Rockley Photonics announces $81.5M private placement
Caretaker Medical VitalStream
FDA clears four new parameters for Caretaker Medical’s wireless patient monitoring system

DeviceTalks Weekly.

August 5, 2022
DTW Medtronic's Greg Smith lays out supply chain strategies
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
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • 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. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. 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
    • Subscribe to Print Magazine
    • 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