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Eye on the FDA

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The MassDevice Weekly Roundup brings you the latest medical device news and information.

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Eye on the FDA: H1 2009

Eye on the FDA

MassDevice’s “Eye on the FDA” report examines key data on the Food & Drug Administration’s 510(k) approvals process on a semi-annual basis, analyzing the approvals according to medical discipline, approval times and a variety of other categories. The reports characterize changes in the number of 510(k) approvals and decision times, identifying the most active medical disciplines and states and offering perspectives on approval trends and developments in the regulatory landscape.

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 more arrow

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The MassDevice Checkup

MassDevice Weekly Checkup chart for November 3 2009

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 more arrow

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News

Abbott wins CE Mark nods for diabetes for its Xience Prime and Xience V stents
Hard on the heels of Boston Scientific’s foray into the European Union with its Promus Element stent, its Chicago rival enters the EU’s diabetes market with its competing drug-eluting stents. Read More more arrow

Phase Forward wins FDA contract for data evaluation tools
The Food & Drug Administration will use the Waltham, Mass.-based firm’s software to review data from clinical trials. Read More more arrow

Boston Scientific’s Promus Element stent wins CE Mark
The third-generation platinum-chromium drug-eluting stent to immediately hit the market in the European Union, just before its private-label deal with Abbott for the original Promus expires. Read More more arrow

CineMed Carrot Medical drums up $635,000
The Waltham, Mass.-based OR communications maker taps 14 un-named investors to raise some cash. Read More more arrow

JAMA: Hologic’s ThinPrep no more effective than Pap smear
A multi-year study in the Netherlands indicates that the Pap smear is just as effective as Hologic’s ThinPrep test, according to the Journal of the American Medical Assn. Read More more arrow

Board chairman John Brown retires after 32-year run at Stryker
The Kalamazoo, Mich.-based medical device giant’s former president and CEO is now its chairman emeritus; in a separate announcement, Stryker moves from annual to quarterly dividends. Read More more arrow

MassDevice Earning Roundup Q3 MassDevice’s earnings roundup
A roundup of medical device makers’ sales and earnings reports. This week: Athenahealth, Beckman Coulter, BioSphere Medical, Bruker Corp., Cynosure, Haemonetics, Hanger Prosthetics & Orthopedics, Hospira, Inverness Medical Innovations, LeMaitre Vascular, NMT Medical, Orthofix, Palomar Medical Technologies, Parexel, PerkinElmer and Phase Forward. Read More more arrow

CDC taps GE Healthcare to track Swine Flu
The healthcare conglomerate will provide surveillance data of influenza activity using its electronic medical records network for one year; GE exec tells MassDevice that program could expand to include other outbreaks. Read More more arrow

Details emerge in federal case against Stryker Biotech
A federal indictment of the Hopkinton, Mass.-based company and some of its top managers sheds light on the charges against them and the company. Read More more arrow

Insulet prices secondary offering at $10.25 per share
The proposed deal would net nearly $58 million for the Bedford, Mass.-based manufacturer of insulin delivery systems; proceeds likely will buy down debt. Read More more arrow

GE Healthcare CTO Harsh: “We’re still practicing sick care”
CIMIT Congress features local innovation and high-profile speakers. Read More more arrow

Alpha Analytical buys Boston Analytical
New England’s largest environmental lab closes its deal for the Salem, N.H.-based contract testing lab. Read More more arrow

Interlace Medical wins FDA nod for fibroid treatment
The Framingham, Mass.-based gynecological device maker wins 510(k) approval for its MyoSure minimally invasive system to remove uterine fibroids. Read More more arrow

GI Dynamics touts another positive clinical trial
The Lexington, Mass.-based bariatric device maker’s EndoBarrier gut liner helped morbidly obese patients in a clinical trail lose weight and control their diabetes. Read More more arrow

Cordis recalls Crossover sheath introducers
Voluntary recall initiated after six reports of problems with its catheter tool, two requiring surgery to retrieve broken pieces. Read More more arrow

Minnesota judge dismisses 600 Sprint Fidelis suits against Medtronic
Citing preemption, a judge in the North Star State dismisses 600 lawsuits over the Minneapolis device giant’s defective defibrillator leads, which are allegedly implicated in more than 100 deaths. Read More more arrow

Helicos continues its search for “strategic alternatives”
The Cambridge, Mass.-based genetic sequencing equipment maker says it’s still in “discussions with multiple strategic parties” with investment bank Thomas Weisel Partners. Read More more arrow

BioSphere taps FDA for investigational exemption
The Rockland, Mass.-based microsphere maker asks the Food & Drug Administration to approve an investigational device exemption for a clinical trial of its QuadraSphere drug delivery treatment for liver cancer. Read More more arrow

Positive study results buoy NxStage
A study showing patients using its home dialysis technology need less anti-hypertensive medications sends the Lawrence, Mass.-based hemodialysis firm’s stock up nearly 5 percent. Read More more arrow

House, Senate healthcare reform bills halve medical device tax
Michael Weinstein was right: The JP Morgan & Chase analyst’s prediction that a proposed $40 billion tax on the medical device industry would be cut in half bears out in House and Senate healthcare reform bills. Read More more arrow

Cordis, Wyeth move to dismiss Boston Scientific stent coatings suit
The Johnson & Johnson subsidiary and the pharma giant say their original lawsuit alleging patent infringement by Boston Scientific and Abbott should take precedence over the Natick device giant’s latest filing. Read More more arrow

HeartWare shareholders vote to open a $60 million spigot
The Framingham, Mass.-based heart pump maker’s stockholders OK issuing nearly 1.4 million new shares of stock from its August private placement with institutional and individual investors. Read More more arrow

AdvanDx lands FDA nod for 90-minute pathogen test
The Food & Drug Administration gave 510(k) approval to the Woburn, Mass.-based diagnostics maker’s test for enterococcal bloodstream pathogens. Read More more arrow

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Jobs

Featured Job: Territory Manager (Southern CA)
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 more arrow

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Features

MassDevice Q&A: Sean Hogan
IBM’s vice president of global healthcare delivery systems on how data collection and analysis will change the face of the healthcare industry. Read More more arrow

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Blogs

Weekly Wireless Roundup: Wireless health killed the stethoscope
An update from the TEDMED conference in San Diego; Vocera, Motorola create smartphone for hospitals; CardioNet’s 15th patent, Cambridge Consultants demos interoperability, US News discovers Hello Health; and Toumaz launches Sensium Life Pebble device. Read More more arrow

MedGadget’s MedTech Monday: Boston Scientific’s John Abele on collaboration
BSX co-founder John Abele’s talk from the TEDMED conference in San Diego on his abiding interest in collaboration; “What to Expect When You’re Expecting” on the iPhone; TomoTherapy releases the new TomoHD radiotherapy system; and ZocDoc goes to Washington. Read More more arrow

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Upcoming Events

Featured Events

Nov. 4, Waltham, Mass. — MDG Forum: Healthcare reform and its effect on medical technology usage

Jeff Voigt of Medical Device Consultants of Ridgewood moderates a panel of experts including Glen Shor off the Mass. Executive Office of Administration and Finance; and Steve Meunier, health policy analyst for Sen. John Kerry.

Other events

Nov. 4, Boston — Future Trends in the Biomedical Engineering Industry

Nov. 5, Waltham, Mass. — 2009 Biotech, Pharma & Physical/Life Science Summit. RSVP to: cwlytle@brandeis.edu

Nov. 9, Cambridge, Mass. — MIT Enterprise Forum, Vaccines & Global Health: New Technologies Create Global Opportunities

Want to list your event on our weekly newsletter? Contact us at editor@massdevice.com.

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