Predictive Diagnostics

Conformal Medical Raises $32M to Advance Next-Gen Stroke Prevention Device

Funding boost to support pivotal trial and pre-commercialization of CLAAS® AcuFORM™ LAAO system. ...

Hesperos’ Human-on-a-Chip® and Digital Twin Platforms Redefine Disease Modeling

CEO Lawrence Florin discusses how human-relevant organ-on-a-chip systems and continuously updated digital twins are improving translational accuracy, reducing reliance on animal testing, and opening new frontiers in precision medicine....

HistoIndex launches FibroSIGHT™ Plus to deliver objective, AI-powered fibrosis measurement in MASH

The company’s second US LDT adds automated qFibrosis® analysis with stain-free SHG imaging, providing continuous, reproducible scores that cut inter-reader variability and support earlier, more personalised care. ...

Nyxoah Receives Approval from FDA for Genio System for Treatment of Obstructive Sleep Apnea

Genio is a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA...

QinFlow Launches Advanced Fluid and Blood Warming Solution to Meet Critical Needs in ORs and ICUs

Founded in 2009, QinFlow is a market leader in fluid thermoregulation solutions. ...

Exact Sciences Announces License with Freenome for Blood-Based Colorectal Cancer Screening Tests

Freenome submitted the final module of the premarket approval application to the FDA for the first version test...

Bracco Imaging’s SonoVue® Secures NMPA Approval for HyCoSy Use in China, Enhancing Non-Invasive Infertility Diagnostics

Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women. ...

Body Vision Medical Secures HSA Approval for AI-Powered LungVision Platform in Singapore

Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics....

Roche’s Elecsys® pTau181 Test Signals Paradigm Shift in Early Alzheimer’s Diagnosis

Dr Ashton Harper, Global Medical Affairs Lead for Neurosciences at Roche Diagnostics, discusses how the CE-marked blood test enhances early detection, reduces invasive diagnostics, and aligns with the advent of disease-modifying therapies....

Roche’s cobas® Respiratory 4-flex wins FDA nod for customisable, multi-virus PCR testing.

Designed for use with cobas® 5800, 6800, and 8800 systems, the cobas Respiratory 4-flex assay simultaneously detects and differentiates SARS-CoV-2, influenza A/B, and RSV, leveraging TAGS technology and digital reflex capabilities to enhance diagnostic precision and efficiency....