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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...

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...

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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...

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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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Covidien puts some skin in Irish medtech startup Fire1

January 9, 2014 10:13 am | by Mass Device | News | Comments

Covidien said it participated in the Series A round for stealthy Irish medical device startup Fire1. Dublin-based Fire1 is developing "novel therapeutic devices" to "address certain unmet medical needs," according to a press release. No...

BD Acquires Alverix

January 7, 2014 2:49 pm | by PR Newswire | News | Comments

BD, a leading global medical technology company, announced today that it has acquired Alverix, Inc., a privately-held diagnostic instrument company known for its optoelectronics expertise. Since 2008, BD and Alverix have collaborated in the...

Boston Scientific names new medical chief for interventional cardiology

January 6, 2014 1:21 pm | by Mass Device | News | Comments

Boston Scientific today announced the appointment of Dr. Craig Thompson as senior vice president and chief medical officer for the medtech giant's interventional cardiology business. Thompson hopes to "further develop the technology...  

CareFusion closes Vital Signs purchase

January 6, 2014 1:15 pm | by Mass Device | News | Comments

CareFusion said it completed a deal with GE Healthcare to acquire Vital Signs for $500 million. Totowa, N.J.-based Vital Signs pulls in about $250 million in annual sales of devices for respiratory care, anesthesiology and patient monitoring...

Medtronic Announces Acquisition of TYRX, Developer of Solutions for Surgical Site Infections

January 6, 2014 12:06 pm | by Medtronic | News | Comments

Medtronic, Inc. today announced that it has acquired TYRX, Inc., a privately held, New Jersey-based developer of implantable combination antibiotic drug and implanted medical devices. TYRX's product offerings include the recently FDA cleared...

Depuy Synthes Spine Launches New Tissue Implant for Spine Surgery

January 6, 2014 11:12 am | by Depuy Synthes Spine | News | Comments

DePuy Synthes Spine, in collaboration with DePuy Synthes Biomaterials, announced today the U.S. launch of CONFORM SHEET, a hydrated, pliable and totally demineralized cancellous bone matrix that fills voids during posterolateral spinal fusion...

Medtronic Begins VICTORY AF Trial of Patients with Persistent or Long-Standing Persistent Atrial Fibrillation

January 6, 2014 10:40 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the first patient has been enrolled in the VICTORY AF clinical trial, a prospective, non-randomized, controlled study of patients with persistent or long-standing persistent atrial fibrillation undergoing an ablation...

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: 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...

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...

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...

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