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The MassDevice Weekly Roundup brings you the latest medical device news and information.
Eye on the FDA: H1 2009
The “Eye on the FDA” report for the first half of 2009 is an exclusive look at 10 years’ worth of Food & Drug Administration 510(k) approvals data. Our investigation reveals that the approval time for medical devices increased nearly 2 percent — while the number of 510(k) applications declined more than 19 percent — even as the FDA’s budgets and staff levels rose. Read More 
The MassDevice Checkup
Our weekly checkup takes the temperature of the public medical device companies in the three largest markets in the U.S.: Massachusetts, Minnesota and California. In addition to the indices for each state, which track the overall movement of the sector, we compare Monday morning’s opening share prices with their value when the markets close Friday afternoon and calculate the biggest gainers and losers. Read More
News
Boston Scientific launches CRM devices in Japan
The medical device-making monolith puts its Cognis CRT-D and Teligen ICD on the market in the Land of the Rising Sun; a springtime software glitch has since been fixed. Read More
Swiss company to buy former Boston Scientific unit Advanced Bionics
Swiss hearing aid maker Sonova to pay $480 million in cash for Advanced Bionics, a year after BSX dumped it for $150 million. Read More
Taris Biomedical names new CMO
The bladder drug/device combination maker taps Julie Lekstrom Himes to be its chief medical officer and head of its clinical development program. Read More
MassDevice’s earnings roundup
A roundup of medical device makers’ sales and earnings reports. This week’s list includes: Abiomed, Angiotech, Becton, Dickinson & Co., Caliper Life Sciences, Charles River Laboratories, Excat Sciences, HeartWare International, Microfluidics, Millipore, NeuroMetrix, NxStage and Smith & Nephew. Read More
Bruker names new COO, CFO
The Billerica, Mass.-based imaging and detection devices maker promotes CFO Bill Knight as its operating chief and promotes accounting head Brian Monahan to as finance chief. Read More
Donald Baim, Boston Scientific’s CMO, dies at 60
The interventional cardiology pioneer, who joined BSX as chief medical officer in 2006, helped put interventional cardiology on the map during a 25-year career at Harvard Medical School, Beth Israel and Brigham & Women’s in Boston. Read More
Covidien completes Aspect Medical Systems acquisition
The medical device monolith acquires the Norwood, Mass.-based brain monitoring equipment maker for $210 million. Read More
HHS subpoenas Boston Scientific’s CRM division
The U.S. Dept. of Health & Human Services wants information on donations to charitis with ties to doctors; Taxus sales continue to slide. Read More
AdvanSource Biomaterials files copolymer patent
The Wilmington, Mass.-based medical device polymer developer files for a patent for its ChronoSil silicone-urethane copolymer. Read More
Boston Scientific settles Guidant Corp. suit for $300 million
The Natick, Mass.-based medical device monolith agrees to settle a U.S. Justice Dept. case, paying nearly $300 million in fines; the charge reverses third-quarter profits into $94 million in Q3 losses and prompts BSX to nearly halve its 2009 earnings guidance. Read More
MediQual Systems sold to Quantros
Buyer pledges to add jobs next year at its new Marlborough, Mass., healthcare data-mining acquisition. Read More
Boston Scientific’s CRM sales VP McConnell to retire
William McConnell Jr., the Natick, Mass.-based medical device giant’s senior CRM sales and marketing executive, plans to retire at the end of the year. Read More
AtriCure settles federal whistleblower case
Without admitting wrongdoing, the atrial fibrillation company agrees to pay $3.8 million to settle Justice Dept. charges that it ran an illegal kickbacks and off-label marketing program aimed at boosting Medicare payments for its procedure. Read More
It’s three for three for Phase Forward as it inks yet another deal
The Waltham, Mass.-based data management provider continues a big week with a third deal in three days. Read More
Ximedica bolsters quality assurance team with new hires
The Providence, R.I.-based medical device development firm adds three industry veterans to expand its quality assurance capabilities. Read More
ProChon Biotech taps Swiss firm to make cartilage growth factor
The Woburn-based knee repair firm inks a deal with Lonza’s Hopkinton, Mass., facility to make the fibroblast growth factor variant for its BioCart knee cartilage repair system. Read More
Echo Therapeutics begins clinical study of transdermal glucose monitor
The Franklin, Mass.-based glucose monitor maker says it will release the results of its Symphony tCGM Biosensor study during the fourth quarter. Read More
SEC drops insider trading case in Johnson & Johnson acquisition
The Securities and Exchange Commission dropped its case against Diopsys CEO Joseph Fontanetta, whom it accused of passing along insider knowledge of J&J’s 2005 acquisition of Animas Corp. Read More
On-Q-Ity drums up $21 million in Series A round
The oncology diagnostics maker, formed from the merger of Cellective Diagnostics and The DNA Repair Co., is developing blood tests to monitor cancer treatments. Read More
Appeals court sends PerkinElmer case back to lower court
The U.S. District Court for Massachusetts must decide whether PerkinElmer failed to adequately promote its defunct Sonoran Scanners acquisition, after a U.S. Court of Appeals for the First Circuit decision that PerkinElmer had an obligation to develop the business. Read More
FDA nods PerkinElmer’s way on neonatal screening device
PerkinElmer landed 510(k) clearance from the Food & Drug Administration for a device that screens newborns for genetic disorders. Read More
J&J to cut at least 7,000 jobs
The cuts are being made as part of the medical products conglomerate’s massive restructuring plan aimed at saving up to $1.7 billion annually. Read More
Jobs
Territory Manager (Southern Calif.)
Haemonetics Corp. is looking for someone to deliver total value proposition and function as a Blood Management Adviser to customer. Effectively sell full line of Patient Division product portfolio focused on growing existing business as well as prospecting new business. Read More
Supply Chain Manager (Marlborough, Mass.) Biomedical Search Consultants is looking for a Supply Chain Manager to oversee multiple supply chain activities to include production planning, purchasing, inventory control, receiving, warehouse stock control, warehousing and distribution at a manufacturing services provider. Read More
Product Manager (Chelmsford, Mass.) Biomedical Search Consultants is looking for a product manager for its client, a manufacturer of medical devices for imaging in the surgical arena. Read More
Manufacturing positions (Hudson, N.H.) OPERON Resource Management is currently recruiting bright, hard-working and experienced employees to fill a wide range of important positions at major manufacturing and logistics companies located throughout New England. Read More
Assemblers, Packers & Inspectors (Clinton, Mass)OPERON Resource Management is filling positions for a clean room staffing team to make high-quality products for Life Science, High-Technology and Defense companies in a sophisticated manufacturing environment. Read More
Blogs
Dollars & Spence: EXCLUSIVE: Facet Solutions snaps up Archus Orthopedics’ IP
MassDevice breaks the news of yet another defunct orthopedic device developer’s acquisition. What does it mean for Facet Solutions and where does that leave the rest of the field? Read More
Weekly Wireless Roundup: Smartphones boost trust among doctors but increase privacy concerns for patients
November 6, 2009 by MassDevice
Physicians laud them but patient rights advocates are leery of smartphones; Mayo Clinic, STM to develop wireless cardiac monitor; WebMDs says its Medscape Mobile app has 200,000+ downloads; and Jitterbug scoops up M-PERS start-up MobiWatch. Read More
Reimbursement Row: Where’s the beef in healthcare reform? Maybe not in Congress.
A pair of examples, one public and one private, of innovative programs aimed at improving the healthcare system. Read More
MedGadget’s MedTech Monday: FiatLux Visualize Free is now free for all
The CT and MRI scan visualization program is now available for download; newborn babies cry with mothers’ accents; camera phone microscope uses holographic processing to view cells; and needle-free insulin delivery from PicoSulin. Read More
Upcoming Events
Featured Events
Nov. 18, Newton, Mass. — MDG networking event: Preclinical Device Qualification: Keeping FDA Happy
Reforming FDA’s regulation of the management, focus, and support of clinical trials, and of the use of electronic clinical trials tools, so as to better enable general healthcare reform and massive U.S. and global innovation, both of which are essential to ending the U.S. and global recessions.
Other events
Nov. 17, Chelmsford, Mass. — ASQ NE Biomedical Discussion Group Roundtable: Medical Device Directive / CE Mark
Practical Applications and Issues
Want to list your event on our weekly newsletter? Contact us at [email protected].
Supplier Spotlight
This week, the Supplier Spotlight shines on Veol Labs, a medical device development company based in India – committed to breakthrough research and paradigm changing innovations. Veol specializes in developing devices for urology, cosmetic surgery, gastroentology, and orthopedics. Browse the Network
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