divendres, 21 de març del 2014

Korean regulators waive registration requirements for some mobile medical devices




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Korean regulators waive registration requirements for some mobile medical devices

By Stewart Eisenhart, Emergo Group




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Presbia files for $90M IPO




Presbia, maker of the Flexiview Micro-Lens corneal implant, registers for an initial public offering worth up to $90 million.





Presbia files for $90M IPO

Presbia, which makes the Flexiview Micro-Lens corneal implant to treat presbyopia, registered with the SEC for an initial public offering of up to $90 million worth of stock.


The Flexiview Micro-Lens is designed to be inserted into a pocket created in the cornea using a laser. The pocket seals itself, holding the 3mm-diameter lens in the center of the visual axis. The 10-minute procedure is reversible and does not require general anesthesia, according to Presbia's website.




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Google Glass startup gains funding for flagship product | Medtech funding stories for the week of Mar. 17, 2014




Here's a look at some of the top funding stories for medical device companies this week.





Augmedix raises $3.2M for Google Glass for docs


March 19, 2014 by Arezu Sarvestani


Augmedix raises $3.2M for Google Glass for docs

Augmedix calls itself the "first and largest Google Glass startup poised to revolutionize healthcare," touting a $3.2 million venture funding round and a move to a larger headquarters in San Francisco.




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Tenn. Sen. Alexander decries the medtech tax | MassDevice.com On Call




Sen. Lamar Alexander (R-Tenn.) spends some time with Memphis-area medical device industry stakeholders to hone efforts to repeal the 2.3% device tax.






MassDevice.com On Call


MASSDEVICE ON CALL — Sen. Lamar Alexander (R-Tenn.) is ramping up his opposition to the medical device tax, spending some time with his medtech stakeholders to renew his call to repeal the tax.




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dijous, 20 de març del 2014

Smiths Medical is off the block after dismal H1 earnings




Smiths Group takes its medical division off of the auction block after the division's H1 earnings drop hard and a multi-billion-dollar acquisition offer from CareFusion falls through.





Smiths Medical is off the block after dismal H1 earnings



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Playtex recalls breast pump adapters over electrical shock risk




Playtex manufacturing launches a nationwide recall of power adapters shipped with Nurser Deluxe Double Electric Breast Pumps over concerns that they may cause electrical shocks.





Playtex recalls breast pumps over electrical shock risk

FDA regulators issued a memo today warning that certain Playtex breast pumps may have been shipped with faulty power adapters that could cause electrical shocks to users.


The recall affects Playtex Nurser Deluxe Double Electric Breast Pumps with adapters that were manufactured from November 2012 through July 2013. The adapters have casings that may be prone to separation, exposing dangerous components.




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K2M Group Holdings looks to raise $100M in IPO | Top Medtech Wall Street stories for the week of Mar. 17, 2014




Here's a look at some of the top Wall Street stories for medical device companies this week.






Spinal firm K2M aims for $100M IPO


March 14, 2014 by Arezu Sarvestani


Spinal firm K2M aims for $100M IPO

Spinal surgery devices maker K2M Group Holdings hopes to raise as much as $100 million through its impending initial public offering, according to registration documents filed with the SEC.





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