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 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 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.
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.
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.
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 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.
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.
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.
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."
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.
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.
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.
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 OptionJuly 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.
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 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 SystemJuly 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.
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 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.
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, 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.
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.
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%.
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%.