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Is the mobile health app market a "medium for mischief"? | MassDevice.com On...
Federal investigators warn that the mobile health app marketplace is rife with poorly researched products and false advertisement.MASSDEVICE ON CALL — The mobile app market could be a "medium for...
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Regulatory science is not boring
By: Susan KellyI'm a relative newcomer to government work, joining FDA about 18 months ago after decades of being a journalist. My job is to assign, write and edit FDA Consumer Updates, news stories...
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Mako Surgical preps $7M public offering | Wall Street Beat
Medical device company Mako Surgical readies a public offering of nearly 500,000 shares worth nearly $7 million to help commercialize its Rio surgical robot.Mako Surgical (NSDQ:MAKO) said it's planning...
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Report: Medical device tax means a 30% spike in industry's federal tax burden
The medical device industry is expecting to pay about $2.5 billion to comply with the medical device tax, representing a nearly 30% increase in the industry's current federal tax burden.Updated...
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Losses gape, sales narrow for BSD Medical
BSD Medical's losses gaped more than 50% on a 32% sales slide during fiscal 2012.BSD Medical Corp. (NSDQ:BSDM) saw its losses increase by more than 50% during fiscal 2012, as sales decreased by nearly...
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Seno Medical Instruments raises $15M
Seno Medical Instruments raises nearly $15 million of a hoped-for $21 million for its opto-acoustic imaging technology for detecting cancer.Seno Medical Technologies raised $14.5 million in an equity...
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Mindray Medical recalls anesthesia delivery systems over potential leak
Mindray Medical recalls its A3 and A5 anesthesia delivery systems over concerns that improper seating of the CO2 absorbent canister may result in leaking gas.Mahwah, N.J.-based medical device maker...
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National VC group targets medical device tax repeal, relaxation
The National Venture Capital Assn. names the 2.3% medical device tax contained in the Affordable Care Act among its top repeal priorities, entertaining opportunities for the industry to repeal or relax...
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FDA blocks Hospira Symbiq touchscreen-enabled infusion pump imports
The FDA prohibits Hospira from importing any new Symbiq infusion pumps systems after the medical device company recalled the devices over a touchscreen issue.Infusion pump maker Hospira (NYSE:HSP)...
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FDA clears Cerner's iPhone-friendly mobile fetal monitoring system
Cerner lands FDA clearance for its Cerner FetaLink+, a mobile maternal and fetal monitoring device that could help clinicians provide high level of care for patients.Kansas City, Mo.-based healthcare...
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Biotronik touts IDE approval, 1st implant for Pulsar-18 stent in Bioflex-I trial
Biotronik won FDA investigational device exemption and announced the 1st U.S. implant of its latest-generation Pulsar-18 self-expanding stent.Cardiovascular medical device maker Biotronik touted FDA...
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MassDevice.com +3 | The top 3 med-tech stories for November 14, 2012
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the...
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Device makers descend on Capitol Hill to fight medtech tax | MassDevice.com...
Medical device lobbying groups organize an executive fly-in to press members of Congress to address the medical device tax before it takes effect in January.MASSDEVICE ON CALL — Medical device...
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The November HIT Standards Committee meeting
By John D. Halamka, MDThe 42nd meeting of the HIT Standards Committee began with an inspirational introduction from Farzad Mostashari. He told us that the HIT Standards Committee members should keep...
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Abiomed wins FDA nod for Impella trial
Abiomed wins FDA approval for an investigational device exemption trial of its Impella RP heart pump for right-side percutaneous cardiac assistance.Abiomed (NSDQ:ABMD) said it's won a nod from the FDA...
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St. Jude Medical lawyer returns to previous firm | Personnel Moves
St. Jude Medical lawyer Steve Tight leaves the company and returns to Minneapolis-based law firm Fredrikson & Byron. St. Jude general counsel heads back to old firmNews Well, Personnel, Personnel...
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Zimmer can't shake Stryker poaching charges
A federal judge rules that Zimmer Holdings must face a jury trial over charges that it ran a deliberate campaign to raid Stryker's sales operations in Las Vegas and Arizona.Legal News, News Well,...
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Mako Surgical prices $40M offering | Wall Street Beat
Medical device company Mako Surgical prices a more than 3-million-share stock offering worth $40 million.Mako Surgical (NSDQ:MAKO) priced a stock offering of more than 3 million shares at $13.15...
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Another warning for CareFusion's Alaris infusion pumps
Certain of CareFusion's Alaris infusion systems, a product line already affected by recalls, are the subject of another warning over potential air bubbles that may be transferred to the patient.Updated...
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GPOs: Novation and Premier ink new deals
Hospital group purchasing organizations Novation and Premier healthcare alliance tout new contract for peripheral vascular and pediatric products./>Group purchasing organization Novation awarded a...
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