MedTech News

Thermo Fisher’s NGS-Based Oncomine Dx Target Test Gains FDA Approval
FDA clears assay as companion diagnostic for ZEGFROVY™ and broad tumor profiling, advancing precision oncology diagnostics.

ReCerf Receives CE Mark, Expanding Access to Advanced Hip Resurfacing in Europe
Ceramic-based hip resurfacing implant gains European regulatory approval, offering patients a bone-preserving, metal-free alternative for hip joint restoration.

Camgenium’s medical device supports pregnant women at risk of pre-eclampsia
Camgenium, a leading medical device software company, has announced that its software product, ‘Reassure Pregnancy’, can improve outcomes for pregnant women at risk of pre-eclampsia through at-home monitoring.

Philips Secures FDA Clearance for SmartSpeed Precise, Advancing MRI Speed and Image Precision
Dual AI-Powered Imaging Software Set to Enhance Diagnostic Confidence and Workflow Efficiency in MRI

A new drug causes nerve tissue to emit light, enabling faster, safer surgery
When surgeons dissect tissue to remove a tumor or make a repair, they must work cautiously, relying on electrophysical monitors and their own anatomical knowledge to avoid cutting nerves, which could complicate the patient’s recovery.

Simple blood test detects unique glycan linked to schizophrenia diagnosis
A group from Nagoya University in Japan has developed a simple, accurate, and sensitive method for measuring polysialic acid, a unique acidic glycan found in the brain. Polysialic acid fluctuates in the blood of patients with psychiatric disorders.

AI microscopy can improve parasite detection in health care
A new study from Karolinska Institutet shows that artificial intelligence (AI) combined with portable digital microscopy improves the detection of intestinal worm infections, so-called soil-transmitted helminth (STH) in resource-limited settings.

PathAI receives FDA clearance for AISight Dx platform
PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight Dx—its digital pathology image management system—for use in primary diagnosis in clinical settings.