Medical Device Industry News | Qmed

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Medical Device Industry News

Former PIP CEO Faces Jail Time

Prosecutors are requesting jail time for the former CEO of French breast implant manufacturer Poly Implant Prothèse (PIP). Terms of the deal would also include a $128,000 fine. Jean-Claude Mas, CEO of the PIP, was in charge when thousands of faulty breast implants were sold to women in the European Union and Latin America.
Boston Scientific Launches Biliary Stent Clinical Trial

Boston Scientific (Natick, MA) hit a 52-week high on the stock market as it announced the start of a new clinical trial. The new clinical trial will test the safety and efficacy of the company’s WallFlex biliary stent.
Analogic Cuts 140 Jobs Amid Restructuring

Analogic (Peabody, MA) will cut 140 jobs as it looks for ways to lower costs in its operations. In March of this year, Analogic acquired Ultrasonix, an ultrasound manufacturer, for $83 million. As of now, the company is consolidating its newly-acquired ultrasound transducer manufacturing capabilities. A Colorado-based plant is currently being closed, and manufacturing is being shifted to the company’s Pennsylvania base.
Elixir Medical Receives CE Mark for Dissolvable Stent

Elixir Medical (Sunnyvale, CA) received CE Mark approval for a new dissolvable stent, dubbed DESolve. The novolimus-eluting vascular implant is designed to prop open blood vessels. Elixir Medical’s newest approval follows approvals for a similar dissolvable stent by Abbott Laboratories.
Life Spine Receives FDA Clearance for Spinal Plate System

Life Spine (Hoffman Estates, IL) received FDA clearance for its IRIS anterior cervical plate (ACP) system. The IRIS ACP system features a low-profile plate with a specialized zero-step nitinol locking mechanism.
Invacare Undergoes FDA Audits as It Reopens Facility

Invacare (Elyria, Ohio) was forced to shut down its local manufacturing facility following an FDA consent decree. However, the company successfully completed an audit that will put it on the path towards normal operations.
OrbusNeich Files New Injunction in Patent Case against Boston Sci

OrbusNeich Medical (Wiesbaden, Germany) is battling with Boston Scientific in Germany over issues related to a patent dispute. OrbusNeich alleges that Boston Scientific violated a preliminary court injunction by selling some of its vascular stents in the United Kingdom through a domestic subsidiary. These stents were blocked from sale in a preliminary injunction due to concerns of patent infringement.
FDA Inspections on the Rise

Federal regulators are cracking down on noncompliant medical device manufacturing facilities, according to the Emergo Group. Warning letters on manufacturing issues reached an eight-year peak in 2012.
CR Bard Pays $48.3 Million in Kickback Scheme Settlement

CR Bard (Murray Hill, NJ) has been forced to hand over $48.3 million as part of a kickback lawsuit settlement. The company was alleged to have used kickbacks to boost the usage of radioactive brachytherapy seeds. These devices are used for the treatment of prostate cancer. In addition to the lawsuit settlement payout, the company faces a $2.2 million fine. The Department of Justice also noted that the company will be forced to improve its corporate compliance procedures.
Edwards Lifesciences Buys Back $750 Million in Shares

Edwards Lifesciences (Irvine, CA) has faced the ire of investors for the past few months. Since the last part of April, shares of the company have dropped 19 percent. In an effort to boost shareholder confidence, the company will buy back $750 million of company stock. In a show of good faith, chairman and CEO Michael Mussallem will participate in the buy back with a $5 million stake.

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