The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific ...

In 2026, biotechnology shifted from promise to proof as the first fully AI-designed drug showed positive human trial results, CRISPR therapies expanded into new disease areas, and the FDA enforced ...

MintNeuro, a pioneer of scalable, low-power semiconductor technology for neural implant applications, and Motif Neurotech, a therapeutic brain-computer interface (BCI) company developing miniature ...

Organizations must adapt to technological advancements by rethinking business models and embracing new software development methodologies like agile and waterfall. Exploring COTS, SaaS, IaaS, PaaS, ...

Motif Neurotech wins FDA clearance for first human trial of a wireless brain implant targeting treatment-resistant depression ...

The FDA has issued updated guidance clarifying the use of electronic systems, records, and signatures in clinical investigations, aiming to enhance data integrity, security, and efficiency. The Q&A ...

Computer vision is driving healthcare gains in imaging, safety, staff well-being, and efficiency, but scaling it requires ...

The market has opportunities in comprehensive training for computer system validation, particularly in regulated industries. Key areas include mastering FDA regulations, agile vs. waterfall ...

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...

On March 18 th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory ...

FDA approval was supported by the one-year results of the TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS® System shown to effectively treat aortic arch disease, including ...