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 […]

Will AI-native drug discovery platforms create a new biotech category in 2026?

Will AI-native drug discovery platforms create a new biotech category in 2026?

As 2026 begins, a new class of biotechnology companies is gaining prominence, not for any single drug, but for how they discover them. These firms, often referred to as AI-native biotechs, are reengineering the drug discovery process around machine learning. Unlike traditional pharmaceutical companies that apply algorithms to specific decision points in an existing workflow, […]

Biohaven ends psychiatric push for BHV-7000 after Phase 2 trial in depression fails to show efficacy

Biohaven ends psychiatric push for BHV-7000 after Phase 2 trial in depression fails to show efficacy

Biohaven Ltd. has reported that BHV-7000, its experimental Kv7 ion channel modulator, failed to meet the primary endpoint in a Phase 2 proof-of-concept trial evaluating the drug in patients with major depressive disorder. The trial assessed changes in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale over six weeks compared to placebo. Although some numerical […]

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