Covidien recalled some lots of its Monoject syringes after discovering a sterilization mishap and labeling problem. The issues affected 14 lots in shipments that went out to customers in the U.S. and Bermuda, the Mansfield, Mass.-based medical products giant said.
Investors pushed shares of Medtronic down this morning after the world's largest pure-play medical device company reported mixed results for its fiscal 1st quarter. Fridley, Minn.-based Medtronic posted profits of $953 million, or 93¢ per share, on sales of $4.08 billion for the 3 months ended July 26.
Boston Scientific Completes Enrollment In SuperNOVA Trial Evaluating Innova™ Self-Expanding Stent SystemAugust 19, 2013 6:02 pm | by PR Newswire | News | Comments
Boston Scientific Corporation (NYSE: BSX) has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of the Innova™ Self-Expanding Stent System (Innova Stent System).
C. R. Bard, Inc. has announced that it has entered into a definitive agreement to acquire privately-held Medafor, Inc., a leading developer and supplier of plant based hemostatic agents for the purchase price of $200 million paid at closing, expected to occur later this year, and future contingent payments up to an additional $80 million based on specific revenue-based milestones through June 30, 2015.
Premier Healthcare Alliance awarded several new contracts for drug-eluting stents, traditional stents and other intervention products to 8 heavy hitters in the cardiology space. Abbott, Boston Scientific, and Medtronic all landed supplier deals for drug-eluting and traditional stents.
The Anapol Schwartz national law firm is now investigating the Class I recall of the Limb Preservation System (LPS) Lower Extremity Dovetail Intercalary Component issued by DePuy Orthopaedics on July 11, 2013. Patients who have suffered a LPS failure are encouraged to contact the firm...
Medtronic Inc. said Monday that it closed its $200 million acquisition of Cardiocom, which develops and provides services that help manage chronic diseases. The Minneapolis-based medical device maker said it doesn't expect the deal to affect its fiscal year 2014 profit.
CAS Medical (NSDQ:CASM) won a round in a legal battle with Covidien's (NYSE:COV) Nellcor patient monitoring subsidiary over technology used to measure oxygen levels in the brain, after a federal judge in Michigan tossed a breach-of-contract claim against CasMed.
Medtronic, Inc. has announced the first implant of a novel deep brain stimulation (DBS) system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy. This initiates research on how the brain responds to the therapy...
A new brain implant that can record neural activity while it simultaneously delivers electric current has been implanted into a patient for the first time. The new device from Medtronic, a Minneapolis-based medical device company, can also adjust its electrical output in response to the changing conditions of the brain.
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.