Subscribe to RSS - FDA

FDA

FDA lifts Invacare’s consent decree

Decree has handicapped company since late 2012
 - 
07/25/2017

ELYRIA, Ohio – Invacare has the green light to make and sell products again from its Taylor Street manufacturing facility and corporate headquarters here, the company announced July 25.

Invacare sets stage for cost reductions

 - 
05/09/2017

ELYRIA, Ohio – Invacare reported $231.7 million in net sales for the first quarter of 2017, a 10% decrease compared to the same quarter last year.

Invacare clear for re-inspection

 - 
04/28/2017

ELYRIA, Ohio – Invacare has completed the final milestones required to lift a consent decree with the U.S. Food and Drug Administration, paving the way for a re-inspection, the company announced April 27.

FDA expands approval for CGM system

 - 
12/23/2016

SAN DIEGO – Dexcom has received expanded approval from the U.S. Food and Drug Administration for the G5 mobile continuous glucose monitoring system.

FDA approves artificial pancreas system

 - 
09/29/2016

NEW YORK – The Food and Drug Administration has approved a commercial version of the Medtronic MiniMed 670G hybrid closed-loop system, an artificial pancreas system.

CMS backs unique device identifiers

 - 
07/15/2016

WASHINGTON – CMS has endorsed the use of unique device identifiers in billing records for medical devices, according to the Wall Street Journal. The ID numbers have been advocated by lawmakers and the U.S. Food and Drug Administration for years, but never by Medicare.

Invacare has more work to do, FDA says

 - 
06/09/2016

ELYRIA, Ohio – Invacare has hit a bump in the road in its goal of lifting a consent decree with the Food and Drug Administration that has handicapped the company since late 2012.

Invacare readies to submit final report to FDA

 - 
02/12/2016

ELYRIA, Ohio – Invacare could be turning the corner on its “ongoing journey” to lift a consent decree with the Food and Drug Administration that has handicapped the company since late 2012.

Invacare auditor submits third report

 - 
02/11/2016

ELYRIA, Ohio – Invacare’s independent auditor this week issued its certification report for the third phase of the consent decree indicating substantial compliance to the FDA’s quality system regulation.

Invacare receives feedback from FDA

 - 
12/18/2015

ELYRIA, Ohio – Invacare has received observations from the FDA following an inspection of its corporate headquarters and Taylor Street manufacturing facility.

Pages