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The ABIM, its finances, and the great collusion

May 26, 2015 By MassDevice Leave a Comment

By Westby G. Fisher, MD, FACC

Filed Under: Blog, Healthcare Reform, Hospital Care, News Well Tagged With: Dr. Wes, Insurance

Sunlamp products & UV Lamps: 3 months to submit 510(k)s to FDA

May 26, 2015 By MassDevice Leave a Comment

William Maisel

By David Lennarz, Vice President and Co-Founder of Registrar Corp

Filed Under: Blog, Food & Drug Administration (FDA), News Well, Regulatory/Compliance

PureTech seeks $160m in U.K. listing

May 26, 2015 By MassDevice Leave a Comment

PureTech seeks $160m in U.K. listing

(Reuters) — Boston-based PureTech Health plans to raise $160 million in a London listing, filling its coffers to fund product development and delivering a vote of confidence on the British life sciences sector.

The move by the U.S. health technology firm follows a similar decision by California-based drug discovery group Verseon to raise $100 million in London earlier this month.

Filed Under: Initial Public Offering (IPO), News Well Tagged With: London Stock Exchange, PureTech, Venture Capital/Private Equity

MassDevice.com +3 | The top 3 medtech stories for May 22, 2015

May 22, 2015 By MassDevice Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

Filed Under: News Well Tagged With: MassDevice.com

Substantial medical device review fee increases at Taiwan Food and Drug Administration

May 22, 2015 By MassDevice Leave a Comment

Emergo Group

By Stewart Eisenhart, Emergo Group

Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.

Filed Under: Emerging Markets, News Well, Regulatory/Compliance Tagged With: Emergo Group

Mind-controlled prosthetic limbs allow precise, smooth movement

May 22, 2015 By MassDevice Leave a Comment

Mind-controlled prosthetic limbs allow precise, smooth movement

(Reuters) — More than a decade after becoming paralyzed from the neck down, Erik Sorto has been unable to perform even the simplest of daily tasks.

Filed Under: Neuromodulation/Neurostimulation, News Well, Prosthetics Tagged With: Keck School of Medicine

Shockwave Medical raises $40 million for its ‘lithoplasty’ system | Medtech funding for the week of May 18, 2015

May 22, 2015 By MassDevice Leave a Comment

PAD: Shockwave Medical raises $40M

May 19, 2015 by Fink Densford

PAD: Shockwave Medical raises $40M

Filed Under: Funding Roundup, News Well Tagged With: ConvaTec, Intact Vascular, NxStage Medical Inc., OrthoSpace, Outset Medical, Shockwave Medical, Smith & Nephew

21st century cures act

May 22, 2015 By MassDevice Leave a Comment

Dr. John Halamka

By John D. Halamka, MD

Filed Under: Blog, News Well Tagged With: Beth Israel Deaconess Medical Center, Life as a Health Care CIO

MassDevice.com +3 | The top 3 medtech stories for May 21, 2015

May 21, 2015 By MassDevice Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

Filed Under: News Well Tagged With: MassDevice.com

Seven mistakes that can delay your FDA 510(k) clearance

May 21, 2015 By MassDevice Leave a Comment

Emergo Group

By Stewart Eisenhart, Emergo Group

Based on data provided by the US Food and Drug Administration as well as Emergo consultants’ experience with medical device manufacturing clients seeking US marketing approval, seven major issues have been identified as the most common perennial causes for delayed premarket notification applications.

Filed Under: Emerging Markets, News Well, Regulatory/Compliance Tagged With: Emergo Group

MassDevice.com +3 | The top 3 medtech stories for May 20, 2015

May 20, 2015 By MassDevice Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

Filed Under: News Well Tagged With: MassDevice.com

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