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FDA approves artificial pancreas system


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


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


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


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


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


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

Plaintiff reaches proposed settlement with Invacare


NEW YORK – The lead plaintiff in a class action lawsuit against Invacare has reached a proposed settlement of $11 million in cash, according to a statement from lead counsel Bernstein Litowitz Berger & Grossman.

Invacare puts ‘turnaround plan’ in motion


ELYRIA, Ohio – With a consent decree with the U.S. Food and Drug Administration (FDA) taking longer than it expected to resolve, Invacare has accelerated efforts to reduce its cost structure by reducing its workforce by 190 employees.

Snug Seat looks to get back in saddle

Company has lost market share since FDA began detaining certain products

MATTHEWS, N.C. – Snug Seat could soon resume distributing in the United States more than a dozen products manufactured in Denmark by R82.

In brief: Drive Medical buys in Europe, The Compliance Team expands service


PORT WASHINGTON, N.Y. – Drive Medical has acquired Dupont Medical, a manufacturer and distributor of healthcare products in France. Based in Frouard, Dupont manufactures and distributes everything from wheelchairs to homecare beds to patient lifts.