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Gagnon Cardiovascular Institute At Morristown Medical Center Implants Newly Approved Device To Replace Failing Aortic Heart Valves

January 24, 2014 4:38 pm | by PR Newswire | News | Comments

The Gagnon Cardiovascular Institute at Morristown Medical Center today became the first hospital in the tri-state area to adopt a new minimally invasive medical device to treat patients with severe aortic stenosis who are too ill or frail...

Covidien Receives FDA Clearance for LigaSure Maryland Jaw

January 23, 2014 11:17 am | by Business Wire | News | Comments

Expanding its industry-leading vessel and tissue sealing portfolio, Covidien received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider. In addition, Covidien completed...

Medtronic Pacing Systems First to Be Approved for Full Body MRI Scans Without Positioning Restrictions

January 23, 2014 11:10 am | by Medtronic | News | Comments

Medtronic, Inc. has announced that the Medtronic SureScan pacing systems—the first and only pacing systems in the United States that have been approved by the U.S. Food and Drug Administration (FDA) for use with magnetic resonance imaging...

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Johnson & Johnson's 4Q Profit Rises 19 Percent

January 22, 2014 11:38 am | by Linda A. Johnson, AP Business Writer | News | Comments

Surging sales of Johnson & Johnson's prescription medicines and the rebound of its recall-plagued consumer health business lifted fourth-quarter profit 19 percent. The health care giant also enjoyed a $707 million tax benefit from... 

GE Will Buy Software Maker API Healthcare

January 22, 2014 11:34 am | by The Associated Press | News | Comments

GE Healthcare said Tuesday that it will buy API Healthcare, which makes software for hospitals and health care staffing agencies. The General Electric Co. unit did not disclose terms of the deal, but said it expects to complete the acquisition...

Covidien to Exit OneShot Renal Denervation Program

January 21, 2014 10:46 am | by Business Wire | News | Comments

Covidien plc has announced it will exit its OneShot Renal Denervation program. This voluntary action is primarily in response to slower than expected development of the renal denervation market. The OneShot system is an over-the-wire...   

Philips Healthcare teams with P-Cure on proton therapy

January 20, 2014 4:29 pm | by Mass Device | News | Comments

Philips aligned itself with Israel-based medical device company P-Cure, in order to advance the smaller firm's proton therapy technology. P-Cure develops low-cost proton therapy systems, which are smaller, cheaper radiation therapy system...

Medtronic CoreValve System Obtains Early FDA Approval on Exceptional Clinical Performance

January 17, 2014 11:17 am | by The Associated Press | News | Comments

Medtronic today announced the U.S. Food and Drug Administration approval of the self-expanding transcatheter CoreValve System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional...

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Renal denervation is 'highly unlikely,' says Medtronic study insider

January 16, 2014 6:13 pm | by Mass Device | News | Comments

The future of renal denervation in treatment of hypertension is shaky at best, according to one of the principal investigators involved with Medtronic's disappointing clinical trial. Despite continued optimism from some of medtech's biggest players...

Covidien Completes Sale of Confluent Surgical to Integra LifeSciences

January 16, 2014 11:26 am | by Business Wire | News | Comments

Covidien plc today announced that it has completed the sale of its Confluent Surgical product line to Integra LifeSciences Corporation for approximately $235 million in cash. In addition, Covidien may receive up to an additional $30 million...

Jury says Medtronic owes Edwards about $390M

January 16, 2014 11:24 am | by The Associated Press | News | Comments

A federal jury ruled Wednesday that medical device maker Medtronic infringed on a patent held by Edwards Lifesciences and ordered Medtronic to pay its competitor about $390 million in damages. Edwards said it will seek a permanent injunction...

Johnson & Johnson’s Ortho-Clinical Diagnostics Acquired for $4.15 Billion

January 16, 2014 11:23 am | by Business Wire | News | Comments

Global alternative asset manager The Carlyle Group has agreed to acquire Johnson & Johnson’s Ortho-Clinical Diagnostics (OCD) business, a global provider of solutions for screening, diagnosing, monitoring and confirming diseases, for...

FDA dings Philips on InnerCool RTx component recall

January 15, 2014 5:09 pm | by Mass Device | News | Comments

The FDA dinged Philips for tardiness in its notification of the recall of a component for its InnerCool RTx body temperature control device in a warning letter sent last month. Philips issued a recall in January 2012 of the main control board for the...

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Integra LifeSciences Completes Acquisition of DuraSeal Product Lines From Covidien

January 15, 2014 2:45 pm | by GlobeNewswire | News | Comments

Integra LifeSciences Holdings Corporation today announced that it has completed the acquisition of DuraSeal product lines from Covidien. Now, together with our DuraGen family of grafts, Integra offers surgeons the largest portfolio of dural repair...

Stryker affirms 2013 guidance, offers limited glimpse of Mako plans

January 15, 2014 1:17 pm | by Mass Device | News | Comments

Stryker CEO Kevin Lobo told an audience at the J.P. Morgan Healthcare conference this morning that its prior guidance for 2013 still holds true and provided a peek at the blockbuster Mako Surgical acquisition the medtech company closed 3 weeks...

Medtronic to Appeal Federal District Court Verdict

January 15, 2014 11:58 am | by Medtronic | News | Comments

A jury in the Federal District Court of Delaware today decided in favor of Edwards Lifesciences, ruling that the Medtronic CoreValve® System infringed on Edward's Cribier patent (US Pat. No. 8,002,825). Medtronic intends to appeal. "While...

Smith & Nephew Co-Sponsors Competition for Entrepreneurial Medical Device Companies

January 14, 2014 11:17 am | by PR Newswire | News | Comments

Smith & Nephew, the global medical technology business, is proud to announce it will co-sponsor the 2014 Massachusetts Medical Device Development (M2D2) Center's New Venture Competition. Designed to showcase innovative ideas coming out...

Medtronic CEO: Value-based healthcare is the only way to save medtech

January 13, 2014 6:35 pm | by Mass Device | News | Comments

There's been a lot of hand-wringing in medtech as healthcare systems around the world have moved from fee-for-service to value-based healthcare models that reward for outcomes, rather than for specific procedures. But for Medtronic CEO Omar...

St. Jude CEO: Medtronic's renal denervation miss doesn't dampen our spirits

January 13, 2014 5:55 pm | by Mass Device | News | Comments

St. Jude Medical CEO Daniel Starks remains steadfast in his pursuit of renal denervation in treatment of hypertension, despite the high-profile clinical trial flop suffered just last week by rival medtech titan Medtronic. St. Jude will continue with its...

St. Jude Medical beats guidance with Q4 prelims

January 13, 2014 9:03 am | by Mass Device | News | Comments

St. Jude Medical said it's likely to top the high end of its 4th-quarter outlook for both sales and earnings, predicting 4% revenue growth and a bottom-line gain of as much as 154% for the 3 months ended Dec. 28, 2013, compared with the same...

Medtronic's miss muddles the renal denervation landscape

January 13, 2014 7:29 am | by Mass Device | News | Comments

Medtech titan Medtronic (NYSE:MDT) rocked the renal denervation world when it reported earlier this month that it's bellwether Symplicity clinical trial failed to meet efficacy expectations when compared to a sham control arm. Physicians and...

Nearly 30 device makers pledge to share data to make patients safer

January 12, 2014 5:49 pm | by Mass Device | News | Comments

The growing Patients Safety Movement has more than doubled its commitments from medtech companies over the course of a single year, with nearly 30 companies promising so far to make the data gathered by their devices available to anyone...

Philips Healthcare signs Patient Safety Movement's data openness pledge

January 12, 2014 4:20 pm | by Mass Device | News | Comments

Technology giant Philips Healthcare is 1 of the newest companies pledging to open up the data gathered by its medical devices in the interest of patient safety, MassDevice.com learned today. Philips Healthcare Patient Care & Clinical...

Nikkiso closes buyout of Baxter's renal business

January 10, 2014 1:14 pm | by Mass Device | News | Comments

Nikkiso America said it closed the buyout of Baxter's continuous renal replacement therapy business for an undisclosed sum. San Diego-based Nikkiso America is the U.S. division of Japanese industrial giant Nikkiso Co. The company’s medical...

Medtronic Renal Denervation Trial Fails to Meet Primary Efficacy Endpoint

January 9, 2014 11:19 am | by Medtronic | News | Comments

Medtronic, Inc. has announced that its U.S. pivotal trial in renal denervation for treatment-resistant hypertension, SYMPLICITY HTN-3, failed to meet its primary efficacy endpoint. The trial met its primary safety endpoint, and the trial's...

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