dimecres, 2 d’abril del 2014

Cytomedix lands $35M for wound care products




Maryland-based Cytomedix secures a $35 million investment commitment from Deerfield Management Co. following an important reimbursement win from the Centers for Medicare & Medicaid Services.





Cytomedix lands $35M for wound care products

Wound care therapies maker Cytomedix(OTC:CMXI) landed a $35 million investment commitment from Deerfield Management Co., to be handed down in 2 tranches.




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AdvaMed taps Covidien's Almeida for chairman | Medtech personnel moves for the week of Mar. 31, 2014




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






Covidien chief Almeida to chair AdvaMed's board


March 26, 2014 by Arezu Sarvestani


Covidien chief Almeida joins AdvaMed's board



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Device tax: Indianapolis Governor petitions Obama for repeal | MassDevice.com On Call




Indianapolis Governor Mike Pence (R) says the 2.3% medical device tax threatens some 20,000 medical device jobs in the Hoosier state.






MassDevice.com On Call


MASSDEVICE ON CALL — Indianapolis Governor Mike Pence (R) issued a formal letter to the White House yesterday, asking President Barack Obama to repeal the 2.3% medical device tax created in the Affordable Care Act.


Pence asked for President Obama's support in "working with the Congress to repeal the medical device tax entirely," saying that the levy threatens 20,000 direct jobs and 55,000 total that rely on the medtech industry in Indiana alone.



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dimarts, 1 d’abril del 2014

Intuitive Surgical hopes to conquer more complex surgeries with new da Vinci Xi




Intuitive Surgical's 4th-generation da Vinci Xi system provides new maneuverability that allows surgeons to tackle more complex procedures and surgeries on multiple sites.





Intuitive Surgical hopes to conquer more complex surgeries with new da Vinci Xi



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Boston Scientific's lead-free S-ICD looks good in 1st real-world study




Boston Scientific's subcutaneous implantable cardioverter defibrillator proves safe and effective in the 1st real-world data from the EFFORTLESS S-ICD clinical trial.





Boston Scientific's lead-free S-ICD looks good in 1st real-world study



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FDA flags Dexcom for not being compliant with new medical device reporting rules | Medtech regulatory news for the week of Mar. 31, 2014




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






Diabetes: FDA warns Dexcom on adverse event reports


March 25, 2014 by Brad Perriello


Diabetes: FDA warns Dexcom on adverse event reports



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Medtech makers warn on new EU rules | MassDevice.com On Call




Medical device makers say they're worried that new regulations in the European Union will slow approvals.






MassDevice.com On Call


MASSDEVICE ON CALL — Medical device makers that relocated to Europe to take advantage of its easier path to approval are worried about new European Union rules, the Financial Times reports.


Companies such as Middle Peak Medical, which is developing a mitral valve implant, moved some of their operations to the EU to escape the FDA's more-stringent approval protocols. But the new EU rules could take a bite out of that advantage, they worry.




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