MedTech News
FDA clears AI-based lung analysis software from Thirona
Thirona announced today that it received FDA 510(k) clearance for the latest update of its AI-based LunQ clinical software.
FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device.
New cause of neuron death in Alzheimer’s discovered
Short, toxic RNAs kill brain cells and may allow Alzheimer’s to develop
Quibim adds new AI cancer detection capability to prostate tool
Quibim, a company using imaging biomarkers for precision medicine, has added a new cancer detection capability to its prostate tool based on AI, QP-Prostate. The updated product, which uses algorithms trained on actual pathology data as ground truth, has been given a CE mark for the European Union and a UKCA mark for the United Kingdom.
Researchers improve blood tests’ ability to detect and monitor cancer
The advance makes it easier to detect circulating tumor DNA in blood samples, which could enable earlier cancer diagnosis and help guide treatment.
New hope for early pancreatic cancer intervention via AI-based risk prediction
MIT CSAIL researchers develop advanced machine-learning models that outperform current methods in detecting pancreatic ductal adenocarcinoma.
FDA approves expanded MRI labeling for Abbott Proclaim neurostim
Abbott (NYSE: ABT)+
announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system.
Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools
The de novo classifications cover software for detecting a lung condition and assessing dementia risk.