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MassDevice Staff

MassDevice Staff

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.

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Former Medtronic CEO William Hawkins reflects on MDT

Former Medtronic CEO William Hawkins reflects on MDT

August 19, 2011 2:14 pm by | 0 Comments

They gave him a sword and he handed them the world.When William Hawkins officially flipped the keys to Medtronic Inc. (NYSE:MDT) over to successor Omar Ishrak, he offered a simple ... Read more
Committee urges investigation into security of wireless medical devices

Committee urges investigation into security of wireless medical devices

August 19, 2011 1:53 pm by | 0 Comments

The recent report of a computer security expert who hacked his own insulin pump got the attention of members of the House Energy & Commerce Committee.This week senior committee members ... Read more
Mobile medical apps to be topic of FDA workshop on agency’s guidance

Mobile medical apps to be topic of FDA workshop on agency’s guidance

August 18, 2011 2:25 pm by | 0 Comments

The FDA planned a public workshop for mid-September to discuss the recently released draft guidance regarding regulation for mobile medical apps.The guidance includes a fairly narrow subset of medical apps, ... Read more
Jacksonville offers $1.6M in aid for Medtronic to create jobs in Florida

Jacksonville offers $1.6M in aid for Medtronic to create jobs in Florida

August 18, 2011 10:52 am by | 0 Comments

Medtronic Inc. (NYSE:MDT) landed a $1.6 million aid package from the Jacksonville City Council, which is hoping the company will expand its Medtronic Xomed surgical technology facility.“This is exactly the ... Read more
FDA tells ‘fallen angel’ medical devices to submit PMAs or be taken off market

FDA tells ‘fallen angel’ medical devices to submit PMAs or be taken off market

August 18, 2011 10:17 am by | 0 Comments

The FDA set an August 23 date for a final rule for three “fallen angel” class III devices to submit premarket applications or be taken off the market as their ... Read more
BSX’s one-time largest shareholder Paulson & Co. sells all $15M in shares

BSX’s one-time largest shareholder Paulson & Co. sells all $15M in shares

August 17, 2011 3:48 pm by | 0 Comments

Paulson & Co. Inc. is Boston Scientific Corp.’s (NYSE:BSX) largest shareholder no more, after liquidating its position in BSX completely by selling off some 15 million shares of the Natick, ... Read more
Japanese trial for Abbott dissolvable stent gets first patient

Japanese trial for Abbott dissolvable stent gets first patient

August 17, 2011 3:02 pm by | 0 Comments

Abbott (NYSE:ABT) enrolled its first patients in a Japanese trial of the Absorb bioresorbable vascular scaffold.The Absorb stent opens clogged blood vessels and provides support to restore blood flow, and ... Read more
Cardiac rhythm management industry still in a slump

Cardiac rhythm management industry still in a slump

August 16, 2011 4:37 pm by | 0 Comments

The cardiac rhythm management industry looks like it needs of a jolt of its own, badly.A look at the earnings releases of two of the big three players in the ... Read more
Benefit-risk determination for premarket applications outlined by FDA

Benefit-risk determination for premarket applications outlined by FDA

August 16, 2011 4:15 pm by | 0 Comments

The FDA released a new guidance yesterday detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for “reasonable assurance of safety and effectiveness.”The agency ... Read more
FDA guidance on clinical trials aims to help device makers

FDA guidance on clinical trials aims to help device makers

August 16, 2011 12:11 pm by | 0 Comments

The FDA took bold steps to outline expectations for medical device premarket submissions in the release of a new draft guidance that outlines the basic structure for clinical trials.The document ... Read more
Incontinence device from Medtronic tests well in clinical trials

Incontinence device from Medtronic tests well in clinical trials

August 16, 2011 9:48 am by | 0 Comments

Medtronic Inc. (NYSE:MDT) got a thumbs up for its InterStim sacral nerve stimulation product’s clinical trials.The Minneapolis, Minn.-based device giant published new data on its InterStim device, showing that it ... Read more
FDA’s 510(k) program unfixable, New England Journal of Medicine agrees

FDA’s 510(k) program unfixable, New England Journal of Medicine agrees

August 16, 2011 9:27 am by | 0 Comments

The Institute of Medicine was right to dub the FDA’s 510(k) medical device program unfixable, at least according to the New England Journal of Medicine.The process of using existing or ... Read more
US healthcare reform wins one, loses one

US healthcare reform wins one, loses one

August 15, 2011 5:42 pm by | 0 Comments

In the latest volley in the individual insurance mandate lawsuits, a Ninth Circuit court dismissed challenges to the reform measure on the same day that a 11th Circuit court ruled ... Read more
Boston Scientific takes a beating amid stock market chaos

Boston Scientific takes a beating amid stock market chaos

August 14, 2011 8:47 pm by | 0 Comments

Shares of Boston Scientific Corp. (NYSE:BSX) traded at unusually high volumes for two straight weeks during the recent roller coast on Wall Street, coming in at more than 120 million ... Read more
Diabetes, obesity device company GI Dynamics opens Australian IPO

Diabetes, obesity device company GI Dynamics opens Australian IPO

August 14, 2011 8:30 pm by | 0 Comments

GI Dynamics officials are still on the down low about their IPO down under, but the company’s offering of more than 72 million shares of stock on the Australian exchange ... Read more