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BioWorld - Monday, May 25, 2026
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

April 15, 2015

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Tendyne enrolls first U.S. patient in early feasibility study for TMVR

When it came to the transcatheter aortic valve replacement (TAVR) market, the U.S. was at least five years behind Europe and other parts of the world. But in recent years the FDA has become much more collaborative and open to getting involved in early feasibility studies, as evidenced by the first U.S. patient to undergo a transcatheter mitral valve replacement (TMVR) procedure in the U.S., as part of a multicenter global feasibility study. Read More

Report from Europe: Med-techs companies find going to SEED in Europe not always a bad thing

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Strand Lifesciences make test to help determine treatments for patients

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Inside the Beltway: FDA tweaks EAP guidance in final; de novo filings also deemed eligible

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Financings: Mitsui invests $5M in EarlySense; total F round now reaches $25M

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Daily M&A: Rosetta Genomics closes its acquisition of CynoGen

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Patent Watch: VeriTeQ seeks patent protection for RFID product components in Brazil

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World in Review: Hansen gets CE mark for Magellan 10Fr catheter

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Products

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Agreements/contracts: Veracyte and GE to collaborate on disease diagnostic solutions

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Briefly noted: MP, WCAS start new acute care solution

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HIT Bits: Practice Fusion, ePatientFinder to launch EHR-based clinical trials

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MDD's Oncology Extra

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