First commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs
Testing on widely available, high-volume cobas 6800/8800 will significantly increase available testing capacity
Roche expedites test development to support urgent need for patient testing during pandemic outbreak to avoid a further spread of the virus at an early stage of infectionContinue reading
Author Archive: AZBio
SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) Now FDA Approved
With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy.
The 50cc TAH-t is 37.5% smaller than the 70cc device while maintaining a peak cardiac output of 7.5 liters per minute making it ideally suited for smaller statured adults and pediatric patients.Continue reading
AZBio Named One of the 30 Most Innovative Companies in Arizona
Az Business magazine has selected the 30 companies that will be honored at the first Arizona Business Innovation Awards.
The 30 honorees were selected from a pool of hundreds of nominations and include AZBio and AZBio Members Xcellerate Biomedical Technologies.Continue reading
Tech Launch Arizona Kicks Off Entrepreneurial Fellowship Program
Tech Launch Arizona (TLA) recently launched the newly developed Student Entrepreneurial Fellowship Program. The fellows comprise a team of four qualified candidates from a diverse range of backgrounds who are eager to make the most of this rare opportunity. Over the course of their employment with TLA they will work closely with the venture development team and gain valuable experience in the startup assessment and launch process.Continue reading
Phoenix Based Paradigm And Viomics Acquired by Exact Sciences
On March 3, 2020, Exact Sciences Corp. (NASDAQ: EXAS) announced the completion of its acquisitions of Paradigm Diagnostics, Inc. and Viomics, Inc., two privately held companies based in Phoenix. Together, Paradigm and Viomics provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery, extending Exact Sciences’ lab testing and research and development capabilities.Continue reading
New FDA Guidance Issued for Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications
On February 25, 2020, the FDA issued two Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications related final guidance documents.
COVID-19 – Government and Industry Work Together to Address a Global Health Emergency
Biotech and Medtech innovators are working to find answers and provide support for people impacted by the Novel Corona Virus (COVID-19). As they work for develop and deliver solutions, get the latest on what you should know, situation updates and key information for travelers, healthcare professionals, the businesses from the Centers for Disease Control at the CDC Information Hub
Avery Therapeutics Co-founder and Chief Executive Officer named a Senior Member of the National Academy of Inventors
Jordan Lancaster is an assistant research scientist with the Sarver Heart Center and founder of Avery Therapeutics, which aims to advance tissue-engineered therapeutics to treat heart disease and muscle injuries. He holds three U.S. patents. Lancaster’s technologies include MyCardia, which is designed to make new blood vessels and “re-muscularize” the heart, making it perform better.Continue reading
EnduRx Pharmaceuticals Awarded $1.4MM of a $1.75MM Grant to Collaborate with MD Anderson Cancer Center to Develop a Novel Therapeutic for Triple-negative Breast Cancer
The 36-month project is a collaboration with MD Anderson Cancer Center in Houston and will advance a novel therapeutic for triple-negative breast cancer to the point of pre-IND meeting with the FDAContinue reading
Arizona Startup Emagine Solutions Technology Receives FDA 510(k) Clearance of its VistaScan Mobile Ultrasound
Emagine Solutions Technology, an award-winning medical software device company located in Tucson, announced that it has received clearance from the U.S. Food & Drug Administration (“FDA”) to market its VistaScan mobile ultrasound platform. Continue reading