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MedAlliance picks up FDA IDE nod for drug-eluting balloon
MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal...
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Fresenius Kabi launches single-needle option for extracorporeal photopheresis
Fresenius Kabi announced the availability of a single-needle venous access option for its Amicus extracorporeal photopheresis (ECP) system. The company announced its availability at the 49th annual...
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Aerami presents positive data for inhaled pulmonary hypertension treatment
Aerami Therapeutics today announced positive data supporting its inhaled imatinib for treating pulmonary hypertension (PH). Studies of AER-901 support progression into a Phase 2 clinical trial. Data...
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BD continues to expand in Ireland
[Image courtesy of BD]BD (NYSE:BDX) announced that it opened a new facility in Ireland and committed a further investment within the country. Last week, the company held a grand opening ceremony for a...
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FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodis may now market and sell SurVeil in the U.S. for...
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Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB,...
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Advanced NanoTherapies picks up $4M investment for drug-coated balloon...
[Image from Advanced NanoTherapies]Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced...
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FDA clears VVT Medical varicose veins treatment device
The ScleroSafe system [Image courtesy of VVT Medical]VVT Medical announced in recent months that FDA has cleared its ScleroSafe platform, which delivers endovenous chemical ablation to treat...
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Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B
MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion. The companies initially announced the planned deal in October of last year. Cordis,...
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FDA approves Boston Scientific’s Agent drug coated balloon
The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific [WtwhTicker symbol=”BSX”](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated...
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