FDA alerts users to issue with Olympus’s endoscope component after patient death
The US Food and Drug Administration (FDA) has issued an alert relating to a problem with a component on endoscopes…
24 Dec 2024
Castle Biosciences reports preliminary data from atopic dermatitis test study
Castle Biosciences has reported preliminary data from its ongoing study of an atopic dermatitis (AD) pipeline test for individuals with moderate-to-severe conditions. The test aims to detect patients more likely…
24 Dec 2024
FDA approves mini version of RECELL GO for smaller wounds
The US Food and Drug Administration (FDA) has approved a premarket approval (PMA) supplement for Avita Medical’s RECELL GO mini, a line extension of the existing RECELL GO system. RECELL…
24 Dec 2024
EVLP platform enables transplants of marginal lungs in UK hospitals
The first successful double-lung transplant using Xvivo's XPS system has taken place in the UK. XPS is an ex-vivo lung perfusion (EVLP) platform that takes donated lungs considered to be…
23 Dec 2024
Signati submits De Novo application to FDA after completing trial
Signati Medical has completed a trial evaluating its device that aims to streamline vasectomy procedures, and submitted a De Novo application to the US Food and Drug Administration (FDA) for…
23 Dec 2024
Sequana shares surge after FDA approval for alfapump
The US Food and Drug Administration (FDA) has approved Sequana Medical’s alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. The agency’s greenlight makes Sequana’s product…
23 Dec 2024
Merit Medical’s WRAPSODY device gains FDA premarket approval
Merit Medical Systems has received premarket approval from the US Food and Drug Administration (FDA) for its WRAPSODY Cell-Impermeable Endoprosthesis allowing the company to commercially launch the device next year…