The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The U.S. Food & Drug Administration will drop user fees for medical device companies by about 7 percent across the board in 2012, the agency said today. “Because of the requirement to give back to industry any funds received in excess of the total fee amount enacted by Congress for the first four years of […]
Baxter International Inc. (NYSE: BAX) put aside $200 million in equity to invest in early-stage companies that “complement” its portfolio. The newly established ” Baxter Ventures will invest globally and focus on innovative technologies with sustainable long-term growth” under the watch of the Deerfield, Ill.-based company’s chief scientific officer Norbert Riedel, according to a press release. […]
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Officials at World Heart Corp. (NSDQ:WHRT) officially pulled the plug on clinical trials of the company’s Levacor ventricular assist device (VAD) technology and laid off nearly half its workforce. The Salt Lake City-based company will layoff 21 of its 50 employees, according to World Heart CFO Morgan Brown, as it looks to reorganize its efforts […]
Stryker Corp.’s (NYSE:SYK) coffers look significantly thinner these days, after the company blew through about 71 percent of its cash and cash equivalents during the first half of 2011 on acquisitions. The Kalamazoo, Mich.-based medical device maker, which started out 2011 with $1.76 billion in cash and cash equivalents now has just under $500 million […]
Premier Inc. announced two new deals yesterday, bringing them to four contracts this week alone. The hospital group purchasing organization signed contracts with Deerfield, Ill.-based Siemens AG (NYSE:SI) and Instrumentation Laboratory of Bedford, Mass. Earlier this week Premier signed contracts with both Covidien plc (NYSE:COV) and Medline Industries Inc. for incontinence products, and announced deals […]
A rebounding Boston Scientific Corp. (NYSE:BSX) said it plans to eliminate up to 1,400 jobs as part of a restructuring program aimed at saving between $225 million to $275 million annually by 2013. The job cuts are “designed to strengthen operational effectiveness and efficiencies, increase competitiveness and support new investments, thereby increasing shareholder value,” according […]
Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences.
Medtronic Inc. (NYSE:MDT) won a partial victory in a Bay State federal court after Judge Douglas Woodlock dismissed two of the three counts filed against it in a whistleblower lawsuit alleging the deliberate off-label promotion of biliary stents. The lawsuit, filed in under seal in 2008 in the U.S. District Court for Massachusetts, alleges that […]
The FDA unveiled a new draft guidance yesterday recommending that class III implantable pacemaker pulse generators be required to submit premarket approval applications or submit notice of completion of product development protocols. “The Cardiovascular Devices Panel recommended that the implantable pacemaker pulse generator (which includes the internal pacemaker battery) be classified into class III because […]
Boston Scientific Corp. (NYSE:BSX) sank $150 million into a five-year plan to expand Chinese commercial operations, including establishing a wholly owned manufacturing site and developing training centers for Chinese health care providers. The Natick, Mass.-based med-tech giant also plans to increase its Chinese workforce six-fold from 200 to more than 1,200 while investing further in […]
In a new draft guidance issued yesterday the FDA sought to clear up confusion about what types of changes to existing medical devices require new 510(k) submissions. The watchdog agency outlined changes to the device features, such as labeling, manufacturing and materials, which require a new 510(k) submission, as well as what types of changes […]
How to turn analytics into actual policy outcomes.
Shares of Covidien plc (NYSE:COV) rose more than 4 percent this morning after the company announced a third-quarter profit bump of 47.0 percent and a top-line boost of 14.1 percent. Wall Street liked the 22 percent sales boost added by the Mansfield, Mass.-based health products maker’s workhorse medical device segment during the three months ended […]
Boston Scientific Corp. (NYSE:BSX) warned that 167 jobs may be cut from its Miami, Fla., facility between Sept. 20 and Oct. 7 this year, according to a filing with the Worker Adjustment & Retraining Notification department of the Florida Agency for Workforce Innovation on Friday. The Natick, Mass.-based medical device giant, which ranked 10th on […]
Cardiovascular Systems Inc.’s (NSDQ:CSII) catheter-based artery de-clogging systems are officially available through hospital group purchasing organization HealthTrust Purchasing Group this month, according to SEC filings. The companies signed a deal in May to make CSII’s orbital atherectomy products, which rub away plaque built up in clogged arteries, available to HPG’s member hospitals. This latest GPO […]
The latest group purchasing organization deal by Upper Midwest Consolidated Services Center thumbs a nose at Medtronic’s (NYSE:MDT) controversial decision to cut several GPO deals earlier this year by replacing a Medtronic contract with a St. Jude Medical (NYSE:STJ) deal. Irving, Texas-based UMCSC announced a one-year contract for cardiac rhythm management products with St. Jude […]
The Massachusetts Life Sciences Center opened submissions for its 2011 tax incentive program this month, through which it will offer up to $25 million in rewards to companies engaged in life sciences research and development, commercialization and manufacturing in the Bay State. MLSC is a quasi-public created by Mass. State legislature in 2006, tasked with […]