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Latest Emergo Group Stories

2014-06-03 23:10:00

Firm's M1 Capnography Mask obtains US market authorization with support from Emergo Group. Seattle, WA (PRWEB) June 03, 2014 Seattle based Monitor Mask Inc., has obtained US Food and Drug Administration 510(k) premarket notification clearance for the M1 Capnography Mask. The M1 Capnography Mask is a disposable oxygen face mask designed to monitor patient breathing by directly interfacing with a sidestream capnograph. Capnography, or exhaled CO2 monitoring, is increasingly recognized...

2013-08-23 23:17:22

New offices anticipate robust medical device market growth in these regions. (PRWEB) August 23, 2013 Emergo Group, a medical device regulatory consulting firm operating worldwide, has opened offices in Turkey and South Africa to provide local support medical device manufacturers active in these markets, and providing assistance to companies looking to enter these markets. In Turkey, Emergo Group has opened an office in Istanbul to provide Turkish medical device registration consulting as...

2013-02-19 23:03:50

Analysis by Emergo Group finds that 42% of FDA 510(k) submissions are cleared within three months. Austin, Texas (PRWEB) February 19, 2013 Review times for medical device 510(k) premarket notifications by the US Food and Drug Administration improved somewhat in 2011 after several years of lengthening review times, according to a new analysis of publically available FDA data by Emergo Group. Most Class II devices and some Class I and III medical devices submitted for registration in the US...

2013-02-13 23:04:08

India-based medical device company obtains Singapore market authorization with assistance from Emergo Group Vapi, India (PRWEB) February 13, 2013 Meril Life Sciences Pvt. Ltd., a medical device manufacturer specializing in products for coronary applications, has received regulatory approval to market its Mozec rapid-exchange PCTA balloon dilatation catheter in Singapore. Available in multiple diameters and lengths, Mozec can be used in a variety of balloon angioplasty procedures. Meril Life...

2012-07-13 23:02:54

Medical device manufacturer expands US market presence with support from Emergo Group. Austin, Texas (PRWEB) July 13, 2012 Olea Medical, a Marseilles, France and Boston, Mass.-based medical technology developer, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US. Designed to run on Windows, Macintosh and Linux operating systems, Olea Sphere provides display, analysis and post-processing functionality for viewing MRI, CT scan and...

2012-03-12 12:00:00

The firm went through pre-market notification with assistance from Emergo Group. (PRWEB) March 12, 2012 SurgiTools Pty Ltd, a Woodvale, Australia-based medical device manufacturer, has obtained 510(k) clearance from the US Food and Drug Administration to sell its Singh Colpotomizer System in the US with assistance from medical device regulatory consultancy Emergo Group. The Singh Colpotomizer System is designed for use in performing total laparoscopic hysterectomies, and provides enhanced...

2012-02-10 12:00:00

Survey from Emergo Group finds that regulatory changes are manufacturers' top concern for 2012 Austin, TX (PRWEB) February 10, 2012 According to a new industry survey conducted by global consultancy Emergo Group, medical device manufacturers plan to increase prices for their products in order to offset the effects of a proposed 2.3% excise tax on all device sales in the US set to take effect in 2013. The annual survey queried 180 medical device industry CEOs, Presidents and Managing...

2012-02-10 15:10:00

Annual survey from Emergo Group finds growing international focus among manufacturers. Austin, TX (PRWEB) February 10, 2012 A new survey by medical device regulatory consultancy Emergo Group has found that medical device manufacturers´ international sales growth rates continued to outpace their domestic business in 2011, demonstrating the increasingly global nature of the industry. The survey of more than 2,600 medical device industry participants showed that more than 53% of...

2011-07-24 00:02:03

Company's Viberect hand-held, non-pharmaceutical device to treat ED obtains FDA 510(k) clearance with support from Emergo Group Chambersburg, PA (PRWEB) July 23, 2011 Reflexonic, LLC, a Chambersburg, PA, based medical device technology developer specializing in urology, has achieved 510(k) clearance from the US Food and Drug Administration to market its non-pharmaceutical product to treat erectile dysfunction (ED), Viberectâ“ž¢. The Viberect device targets men...


Word of the Day
out-herod
  • In the phrase to out-herod Herod, to be more violent than Herod (as represented in the old mystery plays); hence, to exceed in any excess of evil.
Herod refers to 'Herod the Great,' a Roman client king and 'a madman who murdered his own family and a great many rabbis.' According to the OED, the term is 'chiefly with allusion to Shakespeare's use' in Hamlet.
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