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Xlumena

BSX pays $63m for Xlumena | The week in medtech M&A

April 8, 2015 By MassDevice Leave a Comment

Boston Scientific ponies up $63m for Xlumena

April 1, 2015 by Brad Perriello

Filed Under: Mergers & Acquisitions, News Well Tagged With: Boston Scientific, Cogentix Medical, Diabeter, Integra LifeSciences, SeaSpine, Uroplasty Inc., Vision-Sciences Inc., Xlumena

Boston Scientific ponies up $63m for Xlumena

April 1, 2015 By Brad Perriello Leave a Comment

Boston Scientific ponies up $63m for Xlumena

Filed Under: Mergers & Acquisitions, News Well Tagged With: Biliatrics, Boston Scientific, Xlumena

FDA says pancreatic stents are lower-risk at Xlumena’s request

May 29, 2014 By Arezu Sarvestani Leave a Comment

FDA says pancreatic stents are lower-risk

The FDA today issued a final order lowering the risk classification for pancreatic drainage stents at the request of device maker Xlumena.

The FDA agreed that Class II special controls are sufficient to ensure that new devices are safe and effective, taking pancreatic stents off of the more-stringent premarket approval system.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Stents Tagged With: Xlumena

Xlumena wins FDA nod for Axios pancreatic stent

December 19, 2013 By Chris Walker Leave a Comment

The FDA approved Xlumena's Axios stent for treating pancreatic pseudocysts

Xlumena won FDA approval to market its Axios stent and delivery system, landing approval through the FDA’s less-stringent de novo review pathway.

The stent is the 1st specifically designed for the drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Stents Tagged With: Biliatrics, Xlumena

Xlumena wraps up $25M Series C round

December 3, 2013 By Brad Perriello Leave a Comment

Xlumena wraps up $25M Series C round

Xlumena said it closed a $25 million Series C round it plans to use to expand its commercial footprint and win FDA clearance for its Axios stent and delivery system.

Filed Under: Endoscopic, Funding Roundup, News Well Tagged With: Aperture Venture Partners, Ascent Biomedical Ventures, Charter Life Sciences, Prism VentureWorks, Third Point, Xlumena

Xlumena reels in $4.8M in debt financing

August 9, 2013 By Sony Salzman Leave a Comment

Xlumena reels in $4.8M in debt financing

Xlumena closed a $4.8 million debt and securities round with 10 unnamed investors.

Founded in 2007, the Mountain View, Calif.-based company makes ultrasound-guided interventional microscopes, including an FDA-cleared pancreatic cyst access device called Navix.

Xlumena is wrapping up clinical trials to support a 510(k) application for its Axios stent and delivery system, also to treat pancreatic cysts.

Filed Under: News Well, Stents Tagged With: Debt Financing, Xlumena

Funding: Medical device companies raise $70M | Wall Street Beat

September 5, 2012 By MassDevice staff Leave a Comment

MassDevice.com Wall Street Beat

Four medical device companies reeled in more than $70 million in recent weeks, to develop technologies including a laser scalpel for minimally invasive surgeries, a peripheral vessel stapler, a thermal ablation system and a biliary stent.

Cambridge, Mass.-based OmniGuide led the charge with a $35 million round from Orbimed Advisors. OmniGuide chairman Yoel Fink told MassDevice.com in 2010 that the device uses the mirror technology he pioneered at the Mass. Institute of Technology in the 1990s.

Filed Under: Funding Roundup, News Well, Wall Street Beat Tagged With: 180medical, ConvaTec, EndoChoice, Intact Vascular, NeuWave Medical Inc., Novation, OmniGuide, Premier Inc., Teleflex, VirtualScopics Inc., Xlumena

FDA approves expanded use for Abbott’s carotid stent | Regulatory roundup

May 6, 2011 By MassDevice staff Leave a Comment

ABT, FDA logos

Abbott Laboratories (NYSE:ABT) won aproval from the FDA for expanded use of its RX Acculink carotid stent system.

The expanded indication means the stent system can be used to treat carotid artery disease patients who have a standard risk for complications from carotid endarterectomy surgery, a procedure that entails cutting open a patient’s neck artery and scraping out blockages.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Abbott, Novartis, Solta Medical Inc., Sorin Group, Xlumena

MDxHealth wins $1.1 million European grant for cancer research | Funding roundup

May 3, 2011 By MassDevice staff Leave a Comment

Funding

Personalized medicine firm MDxHealth SA (BSE:MDXH.BR) and its research partner NovioGendix B.V. won a $1.1 million grant to support the research and development of a new bladder cancer diagnostic.

The funding came from Eurotrans-Bio, a European Commission initiative that supports biotech R&D between companies and academia.

Filed Under: News Well Tagged With: Angiotech, BioBehavioral Diagnostics Co., Immunetics Inc., MDxHealth SA, National Institutes of Health (NIH), NeuroVigil Inc., NovioGendix B.V., OrSense Ltd., Venture Capital/Private Equity, Xlumena

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