Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA clears Roche's CoaguChek XS Pro

This article was originally published in Clinica

Executive Summary

Roche Diagnostics' latest point-of-care (POC) anticoagulation monitor, the CoaguChek XS Pro, has received 510(k) clearance from the US FDA. The device assesses prothrombin time (PT) and the international normalised ratio (INR), which are measures of blood clotting tendency. This information can be used to adjust doses of the anticoagulant drug warfarin. The meter has a built-in bar code reader that can automatically scan information to identify operators and patients, in conjunction with the firm's RALS-Plus information management system. This could prevent the errors sometimes generated when clinicians manually enter information on PT/INR, Roche says. The system requires 8 microlitres of blood, and can provide results in around one minute, the firm added.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT095237

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel