Category: Beckman Coulter Inc.
Here's a look at some of the top regulatory stories for medical device companies this week: Johnson & Johnson eyes acquisitions in cardiovascular, elsewhere; Abbott CEO defends inversions amid corporate exodus furor; Medtronic fights tax dodging rhetoric in Covidien merger; Could Medtronic-Covidien deal get caught in anti-inversion legislation?; Siemens sells clinical microbiology biz to Beckman Coulter
Beckman Coulter picks up Siemens Healthcare Diagnostics' clinical microbiology business in a closed-doors deal.
Chinese medical device maker Mindray Medical pays $15 million to settle a "commercial dispute" with Beckman Coulter.
Australia's Genetic Technologies settles a lawsuit against Hologic Inc. alleging patent infringement of its genetic testing technology; also, Nomir Medical settles nasty spat with former patent law firm.
Genetic Technologies (NSDQ:GENE) settled a lawsuit against Hologic Inc. (NSDQ:HOLX) over one of its gene testing patents, leaving seven other defendants in the suit.
Women's health firm Hologic was one of nine original defendants in the lawsuit. The settlement involves the licensing of the patent to Hologic in return for undisclosed financial terms, according to a regulatory filing.
A Florida woman is the latest in what's sure to be a long line of plaintiffs filing personal injury lawsuits against Medtronic Inc. over its controversial Infuse bone morphogenetic protein; plus, Beckman Coulter agrees to pony up $5.5M to settle shareholders' class-action lawsuit.
Personal injury lawsuits over its controversial Infuse bone-growth protein are beginning to pile up for Medtronic Inc. (NYSE:MDT), after the Spine Journal revealed serious concerns about the device's safety this summer.
The FDA warns Beckman Coulter on multiple quality issues at its California manufacturing plant, including issues related to its Class 1 recall of an electrolyte assay in May.
The FDA filed a Warning Letter against Beckman Coulter Inc. (NYSE:BEC) this month, detailing a long list of alleged quality issues surrounding the company's manufacturing facility.
Based on an investigation of Beckman's Brea, Calif.-based facility, the watchdog agency found problems with design validation processes, design change processing procedures, personnel training and reporting and execution systems for corrective and preventative actions, among other complaints.
The FDA announces a Class I recall for Beckman Coulter's Synchron clinical chemistry analyzers.
The FDA put a Class I recall on Beckman Coulter Inc.'s (NYSE:BEC) Synchron clinical chemistry analyzer.
The device is a computer-controlled clinical analyzer for determining chemistries in various fluids including blood, urine and cerebrospinal fluid.