Abbott secures FDA and CE Mark approvals for Amplatzer delivery system
Abbott has secured the US Food and Drug Administration (FDA) and CE Mark approvals for its Amplatzer Piccolo delivery system,…
All articles by Gullapalli Prasanna
Gullapalli Prasanna
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MARAbio introduces MAR-Autism Test to detect maternal autoantibodies
MARAbio Systems has commercially introduced a new blood test for identifying maternal autoantibody-related autism. The MAR-Autism Test is designed to…
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FDA clears SleepRes’ Kricket PAP device for obstructive sleep apnoea
The US Food and Drug Administration (FDA) has granted 510(k) clearance to SleepRes’ Kairos positive airway pressure (KPAP)-powered Kricket PAP…
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Zimmer Biomet and OneStep to deliver digital mobility analytics in orthopaedics
Zimmer Biomet has entered an exclusive partnership with OneStep, a digital fall prevention and mobility intelligence platform, to deliver a…
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Thermedical treats first patient in trial of SERF ablation system for VT
Thermedical has treated the first patient in a pivotal clinical trial of its saline-enhanced radiofrequency (SERF) ablation system, used in…
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FDA approves Dilon’s intraoperative margin assessment device
The US Food and Drug Administration (FDA) has granted approval for Dilon Technologies’ MarginProbe 2, a next-generation intraoperative margin assessment…
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Helio Genomics and LiverRight team up for early detection of liver cancer
Helio Genomics and LiverRight have entered a partnership to improve access to early liver cancer detection in the US. The…
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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…
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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…