Industry News
preCARDIA bought by Abiomed
6/3/2021

preCARDIA, which is currently developing a minimally invasive, catheter-based system to treat acute decompensated heart failure, has been acquired by Abiomed. SVB Leerink analysts say the acquisition should "allow the company to build out their long-term product portfolio, potentially positioning the company well to, at some point, return to accelerating double-digit revenue growth."

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Canada OKs handheld ultrasound from Butterfly Network
6/3/2021

Health Canada has given its approval to Butterfly Network for its second-generation iQ+, a handheld ultrasound.

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MassDevice (Boston)
Hematology analyzer from Sysmex cleared
6/3/2021

The FDA has given clearance to Sysmex America for its XN-10 Automated Hematology Analyzer with Blood Bank mode.

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360Dx (tiered subscription model)
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Blood Bank
EU OKs COVID-19 test from iXensor
6/3/2021

European regulators have given CE-IVD mark certification to iXensor for its PixoTest POCT COVID-19 Antigen Test.

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360Dx (tiered subscription model)
Tympanostomy tube system released by Preceptis Medical
6/3/2021

The second-generation Hummingbird tympanostomy tube system, designed for office-based pediatric ear tube procedures, has been released by Preceptis Medical.

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MassDevice (Boston)
Precardia's ADHF system given breakthrough status
6/24/2020

The FDA has given breakthrough device designation to Precardia for its catheter-based system to treat volume overload in patients with acutely decompensated heart failure.

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BioWorld (free content)