MedTech News
.................... by Andrew Celentano

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.

NeuroSigma Announces FDA Clearance of its Second-Generation Monarch eTNS System for Treating Pediatric ADHD
NeuroSigma today announced that the U.S. Food and Drug Administration (FDA) cleared use of NeuroSigma’s second-generation Monarch eTNS System for treating pediatric attention deficit hyperactivity disorder (ADHD)

Clarius wins CE mark for handheld full-body ultrasound tech
Clarius Mobile Health announced today that it received CE mark approval for its wireless handheld whole-body ultrasound scanner.

FDA clears DermaSensor AI-powered skin cancer detection device
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.