KORU Medical’s 510(k) filing for FreedomEDGE with PHESGO could reshape subcutaneous cancer therapy. Find out what this means for oncology care delivery.
Biobeat raises $50M to commercialize its FDA-cleared patch-worn ABPM system. Find out how this device could change hypertension care in the U.S.
KORU Medical’s FDA filing to clear FreedomEDGE for PHESGO delivery could reshape cancer infusion workflows. Find out what it means for oncology care.
New subgroup data on HEPZATO highlights improved survival in low-burden metastatic uveal melanoma. Find out what this changes in clinical strategy.
Overture Orthopaedics hits $1M in sales for its knee resurfacing system targeting early OA. Find out what this milestone reveals about joint preservation.
Find out how Lumos Infinitas’ photonics platform could shift clinical sensing and where adoption hurdles remain. Read analysis and expert insight.
HAI Solutions has received De Novo classification from the U.S. Food and Drug Administration (FDA) for its QIKCAP System, making it the first ultraviolet light-based microbial reduction device to be granted such approval for use with needleless luer-activated IV connectors. The FDA decision establishes a new Class II medical device category, placing the QIKCAP platform
Co-Diagnostics, Inc. has received its first international patent for its Co-Dx PCR platform, with the Australian Patent Office granting coverage for the point-of-care molecular diagnostics system, including its PCR Pro instrument and disposable test cups. This development marks a critical step in the U.S.-based company’s international intellectual property strategy as it advances toward global commercialization
Menarini Silicon Biosystems has reported new secondary analysis results from the PACE trial, reinforcing the potential of its CELLSEARCH Circulating Tumor Cell (CTC) enumeration system as a predictive biomarker for guiding treatment escalation in hormone receptor-positive, HER2-negative metastatic breast cancer. Published in Clinical Cancer Research, the findings suggest that CTC counts in blood samples could
Rhythm Biosciences Ltd and United States-based federated data platform company datma have announced a strategic exploratory collaboration aimed at validating and scaling genomic-integrated cancer risk prediction through real-world clinical datasets. The partnership centers around the use of datma.FED, a privacy-preserving federated data platform, to evaluate the clinical utility and performance of Rhythm Biosciences’ geneType risk