JenaValve Trilogy System’s FDA approval to expand indications to aortic regurgitation
Tailored, minimally invasive solutions are reshaping how complex cardiovascular conditions are treated.
22 January 2025
22 January 2025
Tailored, minimally invasive solutions are reshaping how complex cardiovascular conditions are treated.
The initiative aims to provide a seamless patient experience, bridging the gap between hospital and post-acute care settings.
The US company said that results from the Alpha-CORRECT trial saw its colon cancer diagnostic Oncodetect achieving a sensitivity rate of 91%.
In November 2023, the system received the FDA's breakthrough device designation.
The test employs a combination of tumour-agnostic next-generation sequencing and personalised tumour-informed droplet PCR assays.
The FDA label extension means Nalu’s system is deemed safe to offer patients without compromising future diagnostic imaging needs.
Already cleared in the US for use in soft tissue ablation, Pulse Biosciences is looking to add AF to CellFX’s indication list.
The researchers believe that identifying people at risk of dementia may advance the development of new treatments for the disease.
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