HAI Solutions earns FDA De Novo clearance for QIKCAP UVC IV disinfection device

HAI Solutions earns FDA De Novo clearance for QIKCAP UVC IV disinfection device

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 secures Australian patent for Co-Dx PCR platform, marking global IP expansion milestone

Co-Diagnostics secures Australian patent for Co-Dx PCR platform, marking global IP expansion milestone

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 […]

PACE trial: What Menarini’s biomarker data reveals about escalating treatment in metastatic breast cancer

PACE trial: What Menarini’s biomarker data reveals about escalating treatment in metastatic breast cancer

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 and datma join forces to validate cancer risk tools with federated data

Rhythm Biosciences and datma join forces to validate cancer risk tools with federated data

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 […]

What BIOTRONIK’s partnership with Soin Neuroscience reveals about the future of neuromodulation

What BIOTRONIK’s partnership with Soin Neuroscience reveals about the future of neuromodulation

Soin Neuroscience and BIOTRONIK Neuro have announced a research collaboration focused on evaluating novel waveform technology and adaptive spinal cord stimulation programming aimed at enhancing chronic pain treatment outcomes. The partnership integrates proprietary signal tuning algorithms from Soin Neuroscience with the programmable Prospera SCS system developed by BIOTRONIK Neuro, reinforcing a broader industry shift toward […]

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