Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

PillCam SB approved in Japan

This article was originally published in The Gray Sheet

Executive Summary

Given Imaging receives approval in Japan for its PillCam SB endoscopy video capsule for detection of obscure bleeding. The Israeli firm will launch PillCam SB through 28 sales reps from its Japanese joint venture established in 2002 with medical device and pharmaceutical distributor Suzuken and trading company Marubeni (1"The Gray Sheet" Feb. 14, 2005, p. 22). Given expects to receive a reimbursement decision within nine to 12 months. The firm originally expected approval in 2005 but says that its protracted three year process is average for Japan. PillCam SB already is available in the United States and Europe...

You may also be interested in...



Given Imaging’s Japan Reimbursement Drives 45% Stock Gain In 2nd Quarter

Given Imaging's receipt of Japanese marketing and reimbursement clearance for its flagship PillCam SB ingestible video capsule endoscope system helped propel a 45.5% stock price jump in the second quarter

Given Imaging Eyes Japan, Expanded Reimbursement For PillCam Capsules

Given Imaging plans to aggressively launch the PillCam SB endoscopy video capsule in Japan this year, following approval from the Ministry of Health, Labor & Welfare

The Long And Short Of Accelerated Approval Accountability In US

The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.

Latest News
See All
UsernamePublicRestriction

Register

MT024750

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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