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GE to Expand in Life Sciences with Acquisition from Thermo Fisher Scientific

January 6, 2014 10:28 am | by GE Healthcare | News | Comments

GE and Thermo Fisher Scientific announced today that they have entered into an agreement for GE Healthcare to acquire Thermo Fisher’s HyClone™ cell culture media and sera, and gene modulation and magnetic beads businesses for approximately...

Class I Medical Device Recall: Abbott Diabetes Care, FreeStyle and FreeStyle Lite Blood Glucose Test Strips - Erroneously Low Blood Glucose Results

January 6, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

Affected FreeStyle and FreeStyle Lite Blood Glucose Test Strips may deliver erroneously low blood glucose results when used with the FreeStyle Flash Blood Glucose Meter, FreeStyle Blood Glucose Meter, and the FreeStyle Blood Glucose Meter...

Class I Medical Device Recall: GE Healthcare, LLC - Multi Absorber Original, Disposable - Model M1173310

January 6, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Multi Asborber, Original may have a thin wall condition, which may lead to small holes in the water (drain) tube. This may result in loss of anesthetic gases, ventilations and oxygenation. This product may cause serious adverse health...

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FDA issues warning on Vital Signs' anesthesia devices

January 3, 2014 2:52 pm | by Mass Device | News | Comments

Vital Signs Devices, a GE Healthcare company, issued a warning for its disposable Multi Absorber Original anesthesia system after receiving complaints to a potential safety issue. The disposable Multi Absorber Original is used in the Medisorb...

St. Jude Medical soars to new heights

January 2, 2014 5:28 pm | by Mass Device | News | Comments

Medical device giant St. Jude Medical ended 2013 with a boost, notching a new Wall Street high-water mark of $63.15 on December 26. Shares sank back down to close at $62.74 that day and have since dropped further to close at $61.71 today...

Stryker Announces Definitive Agreement to Acquire Patient Safety Technologies, Inc. for $120 Million

December 31, 2013 9:06 am | by The Associated Press | News | Comments

Stryker Corporation announced today a definitive agreement to acquire Patient Safety Technologies, Inc. for $2.22 per share, with an aggregate purchase price of $120 million. Patient Safety Technologies conducts its business through its wholly...

TorkLaw Continuing to Accept DePuy ASR Hip Implant Cases

December 27, 2013 1:35 pm | by PR Newswire | News | Comments

In November 2013, Johnson & Johnson announced that it has agreed to pay at least $2.5 billion to settle nearly 8,000 DePuy Orthopaedics Hip Implant lawsuits which have been filed across the country.  It is estimated by some accounts...

Medtronic to invest $6M, create 150 jobs in Puerto Rico expansion

December 23, 2013 2:58 pm | by Mass Device | News | Comments

Medtronic is launching a 3-year, $6 million project to boost its footprint on Puerto Rico, in a move that is slated to bring some 150 new jobs to the Caribbean island, according to Gov. Alejandro García Padilla. "Medtronic's expansion...   

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Baxter lands CE Mark for VIVIA multi-setting hemodialysis system

December 20, 2013 1:52 pm | by Mass Device | News | Comments

Illinois medical device maker Baxter's won European regulatory approval for its VIVIA hemodialysis system, designed for use in multiple settings and therapy regimens. The VIVIA system, designed to be operated primarily by a patient, is... 

CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems

December 17, 2013 10:02 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4... 

Henry Ford Hospital Implants New Defibrillator for People at Risk of Sudden Cardiac Arrest

December 16, 2013 1:12 pm | by PR Newswire | News | Comments

A new internal defibrillator, on the cusp of a new standard of care in American cardiology to treat patients for a major heart risk, is being used at Henry Ford Hospital. Compared to the current devices used to treat sudden cardiac arrest...

Siemens Enters Into Master Agreement With Pfizer for Companion Diagnostics

December 16, 2013 9:18 am | by Business Wire | News | Comments

Today, Siemens Healthcare Diagnostics Inc. announces that it has entered into a master collaboration agreement with Pfizer Inc. to design, develop and commercialize diagnostic tests for therapeutic products across Pfizer’s pipeline. Under...

DePuy Synthes Trauma Launches Radial Head Prosthesis System in the U.S.

December 13, 2013 7:15 pm | by PR Newswire | News | Comments

DePuy Synthes Trauma announces that it is launching the new Radial Head Prosthesis System for primary and revision joint replacement of the radial head to restore joint function. The System offers several benefits over current technologies...

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MAKO Surgical to Merge with Stryker Corporation

December 13, 2013 2:45 pm | by Globe Newswire | News | Comments

MAKO Surgical Corp. announced that MAKO stockholders voted at a special meeting of stockholders held today to approve the adoption of the Agreement and Plan of Merger providing for the merger of MAKO with and into a wholly owned subsidiary of...

Stryker fax lawsuit wins class action status

December 13, 2013 10:53 am | by Mass Device | News | Comments

A lawsuit filed by a physician's group against Stryker won its 3rd bid for class action status this week, after a federal judge in Michigan agreed to set the terms for eligibility for the class. The lawsuit, filed by Physicians Healthsource...

Gel Pillow Mask for Sleep Apnea Patients

December 12, 2013 10:03 am | by Royal Philips | News | Comments

Philips Respironics, a unit of Royal Philips, continues efforts to improve therapy options for sleep apnea patients with the industry’s first and only gel pillows mask. Philips Respironics brings the comfort and sealing power of gel to nasal pillows. Light and airy, Nuance is ...

St. Jude Medical Gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

December 12, 2013 8:00 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, has received European CE Mark approval for its 25 mm Portico Transcatheter Aortic Heart Valve Implantation System. The approval expands the number of patients who can be treated using...

FDA Advisory Panel Votes Favorably on the Boston Scientific WATCHMAN™ Left Atrial Appendage Closure Device

December 11, 2013 7:49 pm | by PR Newswire | News | Comments

The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority, Yes: 13, No: 1, that the benefits of the WATCHMAN Left Atrial Appendage Closure device... 

Federal Court Shuts Down Janzen Patent Infringement Claim Against AccessClosure

December 11, 2013 7:00 am | by Business Wire | News | Comments

AccessClosure Inc., the market leader in extravascular closure devices, has announced that the U.S. Court of Appeals for the Federal Circuit denied a request by St. Jude Medical Inc. to rehear an appeal on a double patenting ruling concerning...

Supremes deny Arthrex in $85M loss to Smith & Nephew

December 10, 2013 5:12 pm | by Mass Device | News | Comments

The U.S. Supreme Court declined to entertain an Arthrex appeal of its $85 million patent infringement loss to rival Smith & Nephew, following a lower court's reversal of the earlier ruling. Back in January the U.S. Court of Appeals for...

St. Jude Medical halts Enlightn IV trial

December 10, 2013 3:30 pm | by Mass Device | News | Comments

St. Jude Medical is calling off the Enlightn IV trial of the next generation of its renal denervation technology, just a few months after it began. The trial of St. Jude's multi-electrode Enlightn device was slated to enroll about 590 patients...

Vascular Solutions claims a win against Boston Scientific

December 10, 2013 3:18 pm | by Mass Device | News | Comments

Vascular Solutions claimed a win in its patent infringement lawsuit against Boston Scientific over the Guidezilla catheter, saying a federal judge granted a preliminary injunction against U.S. sales of the BSX device. Vascular Solutions sued...

Revisit Your Patent Licensing Practices Now

December 10, 2013 1:58 pm | by Orion Armon, Partner, Cooley LLP | Blogs | Comments

If your company licenses patented technology (in or out), it is time to revisit your licensing practices in light of recent (and anticipated) changes in patent law. In 2007, the U.S. Supreme Court held in MedImmune, Inc. v. Genentech, Inc...

St. Jude Medical Board of Directors Authorizes $700 Million Share Repurchase

December 9, 2013 4:25 pm | by Business Wire | News | Comments

St. Jude Medical, Inc. announced today that its Board of Directors has authorized a share repurchase of up to $700 million of its outstanding common stock. The repurchases will occur at such times and at such prices as the management of the...

Boston Scientific faces more questions over Watchman implant's effectiveness, risks

December 9, 2013 3:00 pm | by Mass Device | News | Comments

Boston Scientific may have to confront some tough questions when it faces a panel of FDA experts reviewing its Watchman stroke-preventing heart implant. In panel documents released ahead of this week's meeting, the FDA asked its advisory...

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