dijous, 3 d’abril del 2014

Holaira lands $42M for lung denervation trial




Holaira says it raised a $42 million Series D round to back a clinical trial of its lung denervation technology.





Holaira lands $42M for lung denervation trial

Holaira said it raised a $42 million Series D round it plans to use for what it claims as the 1st randomized lung denervation trial with a sham control arm.


Minneapolis-based Holaira said the round was led by Vertex Venture Holdings and included 2 unnamed strategic investors, Windham Venture Partners and existing backers Advanced Technology Ventures, Morgenthaler Ventures, Split Rock Partners and Versant Ventures.




read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1hkM1cT

Hatch bill to repeal medical device tax gains 2 more sponsors




A bipartisan bill that would repeal the medical device tax sponsored by Sen. Orrin Hatch gains a pair of Republican co-sponsors, Sens. Lindsay Graham and Ron Johnson.





Hatch bill to repeal medical device tax gains 2 more sponsors

A bipartisan bill that would repeal the medical device tax sponsored by Sen. Orrin Hatch (R-Utah) gained 2 more Republican sponsors in recent weeks.


Sens. Lindsay Graham (R-S.C.) and Ron Johnson (R-Wis.) each signed on to the "Medical Device Access and Innovation Protection Act," which would do away with the 2.3% excise tax levied on U.S. sales of medical devices as part of the Affordable Care Act.




read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jFvNjN

Halt Medical raises $92.8M ahead of U.S. launch of uterine fibroid treatment




Halt Medical has big plans for its Acessa System for treating uterine fibroids, having raised nearly $93 million in efforts to restructure debt and fund its commercial efforts.





Halt Medical raises $92.8M ahead of commercial launch of uterine fibroid treatment

California women's health company Halt Medical is raising capital ahead of a major commercial bid for its Acessa radiofrequency-based uterine fibroid treatment.




read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1h7TYYM

dimecres, 2 d’abril del 2014

Going global: New AdvaMed chairman Almeida's focus on medtech harmony around the world




Covidien president & CEO AdvaMed board chairman Jose Almeida details his focus for his 2-year tenure as the chairman of the board for medtech lobbying group AdvaMed.





Harmony and ethics: New AdvaMed chairman Almeida's commitment to medtech

Incoming AdvaMed chairman Jose Almeida has an international outlook, planning to focus his 2-year leadership tenure on several goals that aim to reconcile initiatives in the U.S. with efforts overseas.




read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1h4v0cV

Appeals court upholds dismissal in BioMimetic shareholder lawsuit




A federal appeals court upholds the dismissal of a lawsuit brought by shareholders of BioMimetic Therapeutics, acquired by Wright Medical in 2012.





Appeals court upholds dismissal in BioMimetic shareholder lawsuit



read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jBoEB6

Transcend Medical closes on $22M Series C round




Transcend Medical says it closed on a $22 million Series C round, including an investment from an unnamed medical device multi-national.





Transcend Medical closes on $22M Series C round

Transcend Medical said it closed on a Series C round worth $22 million that included a contribution from an unnamed "global pharmaceutical and medical device company."


Transcend, which is developing a micro-stent called the CyPass to treat glaucoma, said it plans to use the proceeds to complete its Compass pivotal trial for the CyPass device. The study's follow-up period is slated to be complete during the 2nd quarter of 2015, according to a press release.




read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1h3b4XU

Medical device recalls for March 2014




Class I and class II recalls issued by the Center for Devices & Radiological Health in March 2014.





FDA logo

March Summary

Class I recalls: 10

Class II recalls: 183


Class I recalls


Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall




read more






from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/PioLGr