Compliance and Regulation

Vertex non-opioid analgesic gets FDA approval
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Vertex’s Journavx, the first analgesic to be approved in a novel class of non-opioid pain medications indicated for moderate to severe acute pain relief.
February 4, 2025
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AliveDx gets CE Mark for multiplex autoimmune test
By LabPulse.com staff writers
AliveDx has received the CE Mark for its multiplex assay for the diagnosis of systemic autoimmune rheumatic diseases.
February 5, 2025
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ABL, Siemens Healthineers sign licensing agreement
By LabPulse.com staff writers
Advanced Biological Laboratories (ABL) and Siemens Healthineers have signed a licensing and transfer agreement of know-how and intellectual property rights from Fast Track Diagnostics Luxembourg to ABL.
February 6, 2025
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BD to separate biosciences and diagnostics business from company
By LabPulse.com staff writers
Becton Dickinson (BD) announced that its board of directors has unanimously authorized a plan to separate its biosciences and diagnostic solutions business from the rest of the company.
February 6, 2025
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PTAB rules 10x Genomics patent claims invalid in Parse suit
By LabPulse.com staff writers
The Patent Trial and Appeal Board (PTAB) has invalidated all claims of patent infringement in 10x Genomics' lawsuit against Parse Biosciences.
February 4, 2025
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Sutter Health, GE HealthCare collaborate on AI-powered imaging services
By LabPulse.com staff writers
Healthcare system Sutter Health and GE HealthCare will collaborate to expand and enhance diagnostic imaging services across Sutter Health's California network.
February 3, 2025
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Modella AI gets FDA breakthrough device designation for generative AI copilot
By LabPulse.com staff writers
Modella AI was granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA) for its generative artificial intelligence (AI) copilot, PathChat DX.
February 3, 2025
PathChat 2a (research use only) is capable of patch, slide, and case level reasoning.
ABB Robotics, Agilent to collaborate on automated lab technology
By LabPulse.com staff writers
ABB Robotics and Agilent Technologies have signed an agreement to collaborate on automated laboratory technology and solutions.
January 29, 2025
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Legal team highlights cautionary clinical laboratory fraud case
By LabPulse.com staff writers
Clinical laboratory litigation indicates growing trend of cases filed by nontraditional whistleblowers.
January 29, 2025
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New report outlines conditions for medical device software risk
By LabPulse.com staff writers
Distinctions can be found throughout the nearly 50-page document.
January 30, 2025
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AdvaMed rallies for state health policies in 2025
By LabPulse.com staff writers
AdvaMed has released key priorities for patient advocacy organizations and professional medical societies.
January 28, 2025
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Lumea, Mindpeak collaborate on AI integration for diagnostic platform
By LabPulse.com staff writers
Digital pathology firm Lumea has entered into a strategic partnership with Mindpeak, a developer of artificial intelligence (AI)-driven image analysis technologies, to integrate Mindpeak's algorithmic tools into Lumea's diagnostic platform.
January 28, 2025
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