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Saturday, November 21, 2009 11:17 PM

Medical Device

Type: Keyphrase
Name: Medical Device
First Reported 11/20/2009 - Updated 11/20/2009 - 2 Documents (in Politics)
Republican Party (US) - Click to view image in its original context
Republican Party (US)
WASHINGTON -- Digging in for a long struggle, Republican senators and governors assailed the Democrats' newly minted health care legislation Thursday as a collection of tax increases, Medicare cuts and heavy new burdens for deficit-ridden states.Despite ... [NewsMax.com - 11/20/2009]
First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents (in Internet & IT)
* Q2 cont ops loss $0.26/ADS* Q2 revenue falls 14 pct to $24.3 mln* Sees Q3 cont ops earnings above $5.6 mln* Sees Q3 revenue of $24.9 mln to $26.4 mln* Shares down 19 pct in pre-marketNov 19 (Reuters) - Medical device maker China Medical Technologies ... [Reuters UK - 11/19/2009]
First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents (in Market News)
Medical device maker China Medical Technologies Inc posted a quarterly loss, hurtby lower revenue from its immunodiagnostic segment, knocking its shares down 19 percent. ... [FDA News - 11/19/2009]
First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents (in Politics)
Rahm Emanuel - Click to view image in its original context
Rahm Emanuel
Topics: Health Disparities, Health Costs, Insurance, Marketplace, Politics, Health Reform, UninsuredKaiser Health News: "The health care overhaul debate in Congress now centers on two bills: the House-passed measure and the Senate Democrats' version unveiled ... [Kaiser Health News - 11/20/2009]
First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents
Medical device company CEOs and other top executives are expressing some optimism about the near-term business outlook, according to a new survey commissioned by MassMedic. Almost two-thirds of those executives surveyed said they expected their business ... [Mass High Tech - 11/20/2009]
Entities: Medical Device
First Reported 11/16/2009 - Updated 11/16/2009 - 1 Documents
AEDs manufactured by Cardiac Science are undergoing a nationwide voluntary medical device correction because of the potential failure of these devices to deliver therapy during use. ... [Theheart.org - 11/16/2009]
First Reported 11/18/2009 - Updated 11/18/2009 - 1 Documents
Food and Drug Administration - Click to view 360-page
Food and Drug Administration
Nov 18 (Reuters) - Medtronic Inc:RECEIVES FDA WARNING LETTER FOLLOWING INSPECTION OF ITS MOUNDS VIEW, MINN.facilityOBSERVATIONS FALL UNDER CORRECTIVE PREVENTIVE REVIEW AND documentation of field action recommendationsOBSERVATIONS ALSO FALL UNDER SUPPLIER ... [Interactive Investor International - 11/18/2009]
First Reported 10/22/2009 - Updated 10/22/2009 - 2 Documents
BusinessWire - Research and Markets (http://www.researchandmarkets.com/research/0feaa9/the_medical_device) has announced the addition of the 'The Medical Device Market: Belgium' report to their offering.The Belgian market is served by a network of experienced ... [Forbes.com - 10/22/2009]
First Reported 10/29/2009 - Updated 10/30/2009 - 3 Documents (in Politics)
The House health care bill released Thursday raises most revenue by taxing individuals making $500,000 or more, but also tightens rules for corporate accounting and takes aim at foreign companies working in tax havens.Weeks of closed-door negotiations ... [CNBC - 10/30/2009]
First Reported 10/29/2009 - Updated 10/29/2009 - 2 Documents (in Internet & IT)
by David RussellMedical device maker Thoratec (THOR) started the session down 13 percent in the last month, but some traders think it still has a pulse.New money flowed into the November 25 calls, which traded 2,000 times for $2.30, according to optionMONSTER's ... [Seeking Alpha - 10/29/2009]
First Reported 10/22/2009 - Updated 10/22/2009 - 1 Documents (in Corporate Deals)
Seventh Sense Biosystems has received a grant of an undisclosed amount from the Bill & Melinda Gates Foundation to help it develop an inexpensive device that can rapidly track malaria infections. The device works by using the company's particle-based ... [SmartBrief - 10/22/2009]
First Reported 10/25/2009 - Updated 10/25/2009 - 1 Documents
Staff at SHL, a manufacturer of drug delivery devices, gathered at the company's Taoyuan, Taiwan-headquarters Wednesday to receive an award recognizing operational excellence from Amgen, the world's largest biotechnology company and a long-time customer ... [BiotechEast - 10/25/2009]

Quotes

... preserves the tax on industry revenues, but cuts the dollar amount by half, to $20 billion over 10 years." This amount, "but not the structure of the tax, now matches that in the House bill." The Senate Finance Committee originally proposed a $40 billion tax on device makers...
...should reconsider all timelines associated with the 510(k) clearance process for medical technology," said MassDevice Publisher Brian Johnson. "Taking into account a new, more stringent approach on the part of the FDA's new leadership and a comprehensive institutional examination of the 510(k) process that will likely result in recommendations for change, the regulatory path for new devices is likely to become longer, more costly and more onerous in the near future."
However, those who would rush the project are not being realistic, he explains. "Congress gave us a mandate in 2007, and told us to go build something that doesn't exist. 'Medical devices' covers a very wide range of products. Medical device manufacturers are very concerned about this. A big piece of this is there is a lot going on globally. It adds quite aa bit of complexity to the project. We're moving as quickly as we can."
The industry 'is taking fire from all sides right now,' Salveson said. "It's unnerving to investors. Unless the valuations improve, [medical device companies] don't want to dip their toes in the water." Medical device companies that do go public are finding a chilly reception. AGA Medical Holdings Inc...

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FACTBOX: Winners, losers in Senate health bill [Reuters - 12 hours ago]
HME Still Under Fire in Senate Health Bill [HomeCare Magazine - 21 hours ago]
Botax: Face Lifts Face $6 Billion Levy From Con... [The Huffington Post | Full News Feed - 11/20/2009]
China Medical takes 2nd-qtr loss; shares fall [Financial News USA - 11/20/2009]
Policy Flashpoints Fuel Reform Debate [Kaiser Health News - 11/20/2009]
Medical device firms show cautiously optimistic... [Mass High Tech - 11/20/2009]
Republicans Blast 'Bait and Switch' Obamacare [NewsMax.com - 11/20/2009]
GOP may not be able to halt debate on Senate he... [Tampa Tribune - 11/20/2009]
The Botax? Nip/tuck Taxes Part of Obamacare [NewsMax.com - 11/19/2009]
China Medical Technologies Posts Second Quarter... [FDA News - 11/19/2009]
UPDATE 1-China Medical Technologies posts Q2 lo... [Reuters UK - 11/19/2009]
BRIEF-Medtronic gets FDA warning letter after i... [Interactive Investor International - 11/18/2009]
Lombard Medical's subsidiary signs agreement to... [M2 - 11/17/2009]
Managing Risk for Silicone Tubing Applications [Medical Device Link - 11/17/2009]
Business staffing plans for Monday, Nov. 16, 2009 [TMC Net - 11/17/2009]
The Canadian Press Business News Budget for Mon... [TMC Net - 11/17/2009]
The Burnham buzz [Research & Development - 11/16/2009]
Medical device correction issued for Cardiac Sc... [Theheart.org - 11/16/2009]
Medical device prices in crosshairs of reform [Reuters - 11/12/2009]
Upgrades & Downgrades: Long Road Ahead for ... [Minyanville - 11/12/2009]
HIGPA 2009 Expo Recap [Dotmed - 11/12/2009]
FDA stresses importance of cybersecurity for ne... [HealthImaging - 11/11/2009]
Are These 3-Digit Stocks Worth Every Penny? [Motley Fool - 11/11/2009]
Symmetry Medical charts expansion in Penang [Business Times Malaysia - 11/10/2009]
AHA kept pushing House for changes as vote slat... [AHA News - 11/09/2009]
FDA's approval time for medical devices increases [News-Medical.Net - 11/07/2009]
Making a Positive ID [Materials Management - 11/06/2009]
Boston Scientific pays $296M to settle Guidant ... [Mass High Tech - 11/06/2009]
Boston Scientific to Pay $296 Million in Settle... [Law.com - Newswire - 11/06/2009]
Boston Scientific Settles DOJ Guidant probe; Lo... [RTTNews.com - 11/06/2009]
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Doctor: I Was Fired for Fighting Hospital’s Tie... [WSJ.com: Health Blog - 11/02/2009]
Medical device companies like Medtronic have been under fire lately for their megabucks deals with doctors who can influence purchases of medical products. So what ...
Bulls Charge Thoratec Pre-Earnings [Healthcare Sector and Stocks Analysis from Seek ... - 10/29/2009]
optionMONSTER submits: by David RussellMedical device maker Thoratec (THOR) started the session down 13 percent in the last month, but some traders think it still ...
Capital Eye Opener: Monday, October 19 [Capital Eye - 10/19/2009]
Your daily dose of news and tidbits from the world of money in politics: ARE WE ALL JUST PRISONERS HERE OF OUR OWN DEVICE? Seems a little odd, perhaps, that U.S. ...
More on Christie’s “Ongoing Financial Relations... [Emptywheel - 08/18/2009]
This will just be a hodgepodge of details to follow up on this story, the news that former NJ US Attorney and current GOP candidate for Governor, Christ Christie ...
Communicating Risk in Online Drug Ads: Reading ... [Pharma Marketing Blog - 05/29/2009]
DDMAC's (FDA) recently-released "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device" (pdf file here) focuses almost exclusively ...
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