IBJNews

At long last, Roche wins approval of Nano

Back to TopCommentsE-mailPrintBookmark and Share

Finally.

Roche Diagnostics Corp. this month won approval from the U.S. Food and Drug Administration for its Accu-Chek Nano SmartView blood glucose monitoring system.

The approval comes more than two years after FDA officials declined to approve a previous version of the Nano, which in rare cases generated inflated blood-sugar readings because it did not distinguish properly between the sugars glucose and maltose.

That left Roche bereft of its latest technology in the U.S. market, even as Nano devices sold well in Europe. Roche’s troubles with the Nano contributed to a stagnation in Roche’s sales of blood glucose monitors, which totaled $2.6 billion in 2010, according to the latest year-end data from San Francisco-based market research firm Close Concerns Inc.

"The Accu-Chek Nano meter is the newest advancement in Roche's more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers,” Luc Vierstrate, the global head of Roche Diabetes Care, said in a prepared statement. “This new system will help us to further leverage and enhance our position in this important market."

The Nano SmartView is designed to be easier to use for diabetics, who must test their blood multiple times per day to determine what they can eat and when they need to take a dose of medicine, such as insulin. It is about as wide and tall as a credit card, and does not, as earlier versions of Accu-Chek meters do, require patients to input a code to calibrate the meter before use.

It’s the second bit of good news for Roche’s diabetes business in as many months. In November, Roche announced it will partner with San Diego-based DexCom Inc. to incorporate its continuous glucose monitoring sensor with a wireless handheld device Roche is developing to help diabetics test their blood sugar and track their glucose levels throughout the day.

Continuous glucose monitoring is seen as the next wave of innovation in the blood glucose monitoring market, yet Roche has been running behind its competitors on getting such a product to market.
 

ADVERTISEMENT

  • Roche doing massive reduction in sales force this week, January 16, 2012
    They have their new meter approved and test strip plus got their improved test strip approved last quarter of 2011. Now they are laying off about 36% or so of their salesforce this week, quiety without anyone outside seemingly noticing.

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
ADVERTISEMENT