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Johnson & Johnson can exclude recall evidence in DePuy ASR bellwether lawsuit

August 9, 2013 1:13 pm | by Mass Device | News | Comments

Evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial over the device, a federal judge ruled last month. Johnson & Johnson's DePuy Orthopaedics division pulled the DePuy ASR device from the market in 2010, prompting thousands of personal injury lawsuits across the country.

Boston Scientific prices $1B debt offering

August 9, 2013 11:37 am | by Mass Device | News | Comments

Boston Scientific said it plans to use the proceeds of a $1.05 billion debt offering to retire some of its other debt coming due over the next few years. The Natick, Mass.-based medical device company said it will offer $600 million worth of 2.65% senior notes due Oct. 1, 2018, and another $450 million worth of 4.125% notes due Oct. 1, 2023.

Zimmer owes Stryker $210M for willful infringement

August 8, 2013 1:31 pm | by Mass Device | News | Comments

Zimmer is on the hook for more than $210 million in damages owed to rival Stryker, after a federal judge in Michigan tripled a jury's $70 million decision. Kalamazoo, Mich.-based Stryker sued orthopedics rival Zimmer in December 2010, alleging infringement of 3 patents covering wound debridement technology with Zimmer's Pulsavac Plus device.

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Conflicting decisions and new tactics in Medtronic Infuse lawsuits

August 8, 2013 1:06 pm | by Mass Device | News | Comments

The battle over Medtronic's Infuse bone-growth protein continues to be a roller-coaster, with judges in 2 states issuing seemingly conflicting rulings about the validity of patient injury lawsuits against the Minnesota medical device giant and its troubled Infuse bone-growth protein.

Cordis recall of Optease vena cava filter is Class I

August 8, 2013 12:01 pm | by Mass Device | News | Comments

The recall last March of Johnson & Johnson unit Cordis Corp.'s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death. Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.

GE, University of Washington to Develop 'Diagnostics-on-Demand' Device

August 8, 2013 9:00 am | by Business Wire | News | Comments

You’ve heard of on-demand TV, now imagine on-demand medical diagnosis – anytime, anywhere in the world. Scientists at GE Global Research are working with a team based at the University of Washington to develop a new medical device, the size of a pack of playing cards, that can detect infectious disease by way of a simple nasal swab, in less than an hour.

Stryker Interventional Spine Launches Two New Products to Expanding Portfolio

August 7, 2013 12:15 pm | by PRNewswire | News | Comments

Stryker Interventional Spine announced the clearance of 510(k)s for two additional products to its portfolio. Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain. The launch of the 11g iVAS Balloon System addresses the surgical trend of shifting toward less invasive treatment options.

Labeling glitch with Boston Scientific's Promus Element Plus prompts recall in Australia

August 7, 2013 12:01 pm | by Mass Device | News | Comments

Boston Scientific shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country's Therapeutic Goods Administration to issue a recall. The Promus stents were shipped with incorrect directions for use Down Under, according to a TGA release.

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Philips Announces FDA Clearance for Its Pinnacle³ Proton Treatment Planning System

August 7, 2013 11:02 am | by Philips | News | Comments

Royal Philips today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Pinnacle³ Proton treatment planning system in the U.S. Philips’ Pinnacle³ is a recognized treatment planning system for external beam radiotherapy, which provides accuracy and reliability to users independent of the treatment delivery system.

New Siemens CEO: 'Company is most definitely not in a crisis'

August 6, 2013 12:52 pm | by Mass Device | News | Comments

Newly appointed Siemens CEO Joe Kaeser is bullish about the company's prospects, calling Siemens "virtually unbeatable" – as long as it retains the right people. Kaeser, Siemens' former CFO who took over the corner office just last week, said in a recent shareholders letter that his top priorities at the moment are "to steer Siemens back into calm waters and build a powerful team."

J&J Pleased Chinese Anti-Monopoly Dispute Is Over

August 5, 2013 12:50 pm | by The Associated Press | News | Comments

Healthcare giant Johnson and Johnson says it is pleased to put a legal dispute behind it after a Chinese court ordered it to pay compensation to a former distributor under an anti-monopoly law. Thursday's ruling said Johnson & Johnson was guilty of "vertical monopoly" for setting minimum prices its distributors charged for surgical sutures.

China fines Johnson & Johnson in landmark price-fixing case

August 2, 2013 1:26 pm | by Mass Device | News | Comments

Johnson & Johnson (NYSE:JNJ) won the dubious distinction of being the 1st Fortune 500 company to be fined for price fixing in China, according to a newspaper there. The healthcare giant was fined 530,000 yuan (about $86,456) by the Shanghai High People's Court yesterday to compensate a former Chinese distributor, Rainbow Medical, China Daily reported.

Camera Crushes Patient; Sparks Recall

August 1, 2013 12:40 pm | by David Mantey, Executive Editor, MDT | News | Comments

This week, the U.S. Food and Drug Administration (FDA) announced the recall of GE Healthcare’s Nuclear Medicine Systems were recalled following an incident at a VA Medical Center in which a patient died due to injuries sustained while being scanned.

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Siemens replaces CEO Löscher with CFO Kaeser

July 31, 2013 1:31 pm | by Mass Device | News | Comments

After a week of speculation about Peter Löscher's grasp on the chief executive title at Siemens (NYSE:SI), the board of directors made good on its promise to "decide on early retirement" today, ousting the former CEO 4 years before his contract was up.

GE Healthcare Submits the Final Module of Its Premarket Approval Application (PMA) for GE Breast Tomosynthesis Option

July 30, 2013 9:00 am | by Business Wire | News | Comments

GE Healthcare, a unit of General Electric Company (NYSE:GE), announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA1) for GE Breast Tomosynthesis, an option of the Senographe Essential system.

Shuffle at the top: Siemens CEO on the way out

July 29, 2013 2:44 pm | by Mass Device | News | Comments

Siemens CEO Peter Loescher may be booted from the corner office, according to a surprise weekend announcement from the healthcare giant's board of directors. Loescher's pending departure, which comes 4 years before the end of his contract, will likely be finalized at Wednesday's board meeting, according to company reports.

ReVision Optics sees $55M funding round

July 29, 2013 12:11 pm | by Mass Device | News | Comments

ReVision Optics said it's raised $55 million from a consortium of investors and closed enrollment in a clinical trial of its Raindrop near vision inlay to treat presbyopia. The Lake Forest, Calif.-based company said all of its existing backers – Canaan Partners, ProQuest Investments, InterWest Partners and Domain Assoc. – were joined by new investors Johnson & Johnson Development Corp. and RusnanoMedInvest in the round.

Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and β–Ketone Monitoring System

July 29, 2013 11:09 am | by Abbott | News | Comments

Abbott has announced that it has received U.S. FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System, an advanced blood glucose monitoring system designed to address the key needs of hospital customers: high accuracy, efficient operation, dual-band wireless access to immediate test results, and helps in the reduction of the risk of test strip cross-contamination.

Class I Medical Device Recall: GE Healthcare Nuclear Medicine Systems

July 29, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals...

Fidelity buys into the Boston Scientific comeback story in a big way

July 25, 2013 4:36 pm | by Mass Device | News | Comments

Fidelity bought into the Boston Scientific comeback in a big way, revealing in a regulatory filing a nearly 10.5% stake in the medical device company. With its investment, Fidelity supplants Dodge & Cox., as Boston Scientific's largest institutional shareholder.

Johnson & Johnson subsidiary gets Class I recall for implantable infusion pumps

July 25, 2013 11:29 am | by Mass Device | News | Comments

The FDA puts its highest-risk label on a recall of programmable infusion pumps made by Codman & Shurtleff Inc., a division of Johnson & Johnson subsidiary DePuy Orthopaedics. Codman's implanted MedStream pumps were recalled over a potential defect in a component that measures the contents of the pump reservoir.

Medtronic Provides Grant for Program Focused on Medical Devices for Developing Countries

July 24, 2013 10:48 am | by Johns Hopkins University | News | Comments

Medtronic, one of the world’s largest medical technology companies, has entered into an innovative partnership with The Johns Hopkins University, agreeing to provide $200,000 a year for up to three years and skilled mentoring to help biomedical engineering students design new healthcare solutions for underserved patients in developing countries.

Faulty Sensor Forces Infusion Pump Recall

July 23, 2013 3:32 pm | by David Mantey, Executive Editor, MDT | News | Comments

The FDA today announced the recall of the MedStream Programmable Infusion Pump, an implanted device from Switzerland-based manufacturer Medos Internationalused to treat muscle spasms caused by multiple sclerosis, cerebral palsy, or damage to the brain or spinal cord.

Rejuvenate hip recall hits Stryker's Q2 profits

July 19, 2013 2:45 pm | by Mass Device | News | Comments

Stryker said an unexpected, $170 million hit related to its recalled Rejuvenate hip implant pushed its 2nd-quarter profits down nearly 35% and lowered its earnings outlook for the rest of the year. The Kalamazoo, Mich.-based medical device company posted profits of $213 million, or 56¢ per share, on sales of $2.21 billion during the 3 months ended June 30, for sales growth of 5.0% but a bottom-line slide of 34.5%.

GE Healthcare's Q2 profits rise on flat sales

July 19, 2013 12:07 pm | by Mass Device | News | Comments

General Electric (NYSE:GE) said today that its GE Healthcare division posted 2nd-quarter profit gains despite flat sales, as the parent conglomerate beat Wall Street's earnings forecast by a penny. GE Healthcare logged profits of $726 million on sales of $4.49 billion for the 3 months ended June 30, for a bottom-line gain of 4.6% but a top-line slip of 0.2%.

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