MDUFA, PDUFA, FDASIA head out to Pennsylvania Avenue

Posted on Wed/27/JuneMon/28/January by AZBio

After a long and collaborative effort between the FDA and Industry, the Food and Drug Administration Safety and Innovation Act (FDASIA) including reauthorization of MDUFA and PDUFA head to the White House for signature into law. Continue reading→

June 2012 Washington Run Down

Posted on Fri/15/JuneMon/28/January by AZBio

A Washington Update for AZBio Members.Continue reading→

The Medical Device Tax: Repeal it for the sake of innovators and patients

Posted on Fri/8/JuneSun/10/June by AZBio

As industry leaders we all need to stay in the loop on key issues that affect our industry and our state. One of those issues is the 2.3% Medical Device Tax. When we were out in DC last April, AZBio leadership met with all of our Congressional teams to share information on how this tax impacts our industry and our state . In addition to sharing with them what is happening here in Arizona, we asked them if they would keep us “in the loop” on what is happening at our nation’s capitol.

On Thursday, June 7, 2012 we got some important news from Capitol Hill.

Read on for a special “In the Loop” guest post by Congressman Paul Gosar, R-AZContinue reading→

21-Year-Old College Student Literally Dances Her Heart Out

Posted on Thu/7/JuneMon/28/January by AZBio

Dancer Mia Welch Bridged to Heart Transplant with SynCardia Total Artificial HeartContinue reading→

Innovators Reach Out to DC on the Impact of the Medical Device Tax

Posted on Thu/7/JuneMon/28/January by AZBio

Arizonans Join Leaders From Across the Country to Weigh In On The Reasons For a Medical Device Tax Repeal as the U.S. House of Representatives Prepares to take it to a vote.

Continue reading→

Flagship Biosciences finds Arizona a great home for serving pathology digitally

Posted on Tue/5/JuneMon/28/January by AZBio

Flagship Biosciences, a fast growing pharmaceutical services company based in Flagstaff, AZ, is a leading example of the power of the collaborative nature of the Arizona bioindustry.Continue reading→

Flagship Biosciences expands with acquisition of IHCtech

Posted on Mon/4/JuneMon/28/January by AZBio

Flagship Biosciences acquires IHCtech, a leading provider of research immunohistochemistry and histology services

Combining tissue analysis with expert immunohistochemistry completes Flagship’s novel quantitative pathology approachesContinue reading→

SynCardia Wins 2012 Medical Design Excellence Award

Posted on Thu/31/MayMon/28/January by AZBio

Freedom® Portable Driver for Powering SynCardia’s Total Artificial Heart Honored in Critical Care and Emergency Medicine Category

SynCardia Systems, Inc., the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the company’s Freedom® portable driver, the world’s first wearable power supply for the SynCardia temporary Total Artificial Heart, was selected as the Bronze Winner in the Critical Care and Emergency Medicine category of the 2012 Medical Design Excellence Awards (MDEA) on May 23 in Philadelphia.

“It is an honor to have the premier competition for medical device design and innovation recognize the achievements of our Freedom portable driver,” said Michael Garippa, SynCardia Chairman/CEO/President. “For the first time in U.S. history, the Freedom portable driver is allowing stable patients without human hearts to leave the hospital and resume their lives at home while they wait for a matching donor heart. The Freedom driver is pivotal in the Total Artificial Heart becoming the new standard of care for end-stage biventricular heart failure.”

Weighing 13.5 pounds, the Freedom portable driver is designed to be worn by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. More than 80 patients worldwide have been supported by the Freedom driver, accounting for more than 30 patient years of support.

MDEA entries were evaluated on the basis of their design and engineering features, including… read more at SynCardia.com