Vaxxas gains Australia’s TGA licence to manufacture HD microarray patch
Vaxxas has received a manufacturing licence from Australia’s Therapeutic Goods Administration (TGA) for its high-density microarray patch (HD-MAP) for clinical…
All articles by Gullapalli Prasanna
Gullapalli Prasanna
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FDA approves P&F’s transcatheter bicaval valve system trial
The US Food and Drug Administration (FDA) has granted approval to P&F USA to begin the randomised, controlled TRICAV II…
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Vesalio secures FDA clearance for enVast clot retriever
The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its…
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Guardant Health and Trial Library to expand access to US cancer trials
Guardant Health and AI technology firm Trial Library have formed a strategic partnership aimed at improving access to cancer clinical…
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Impulse Dynamics raises $158m to advance clinical and technology pipelines
Impulse Dynamics has secured over $158m in funding aimed at supporting its commercialisation efforts and progressing its clinical and technology…
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First patient treated in Nitinotes’ trial of EndoZip system for ESG
Nitinotes has commenced its US investigational device exemption (IDE) Endoscopic Automated Sleeve Evaluation (EASE) clinical trial, with the first patient…
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Pulse Biosciences and MD Anderson to study nPulse for thyroid cancer
Pulse Biosciences has entered a research partnership with The University of Texas MD Anderson Cancer Center, US, to investigate the…
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Roche gains CE Mark for bacterial vaginosis/candida vaginitis assay
Roche has secured CE Mark approval for its cobas bacterial vaginosis/candida vaginitis (BV/CV) assay to support the diagnosis of infectious…
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Aquapass’s fluid overload therapy system gains marketing approval in Israel
Aquapass has secured marketing approval in Israel for the AQUAPASS System, intended for patients experiencing fluid overload. The approval allows…
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Lunit seeks FDA clearance for breast cancer risk prediction model
Lunit has announced the submission of a 510(k) premarket notification seeking clearance from the US Food and Drug Administration (FDA)…