Enlil and Interlynk Partner to Close the Cybersecurity Gap for SaMD and Connected Medical Devices

The integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When ...
MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

CLEIO Expands Integrated Product Development Capabilities for Medical Devices and Digital Health

Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
Medical Device and Diagnostic Industry (MD+DI)

CGM Manufacturer Views FDA’s New Rules on Wearables as “Catalyst” for Accelerated Commercialization

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.
JD Supra

Automation Bias and Clinical Practice: FDA Makes Incremental Updates to Clinical Decision Support Software Guidance

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS ...

OneMedNet Real-World Data Supports FDA 510(k) Clearance of AI-Powered Scaida BrainCT-ICH Software

OneMedNet’s regulatory-grade Real-World Data—spanning longitudinal electronic medical records (EMR), diagnostic imaging, and associated clinical reports—played a critical role in supporting model ...
JD Supra

FDA Adapts with the Times on Digital Health: Updated Guidances on General Wellness Products and Clinical Decision Support Software

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

BioticsAI, which won Disrupt’s Battlefield competition in 2023, gains FDA approval for its AI-powered fetal ultrasound product

TechCrunch Disrupt Battlefield 2023 winner, BioticsAI, announced on Monday that it has received FDA clearance for its AI ...
IEEE

A novel technique for Software Fault Injection Testing through FPGA code instrumentation for verification and validation of software on-board launch vehicles and spacecraft

Abstract: Software Fault Injection Testing (SFIT) is a technique used in verification & validation (V&V) in order to test the error handling logics in the software on ...

LEADOPTIK Announces FDA Clearance of the LIA(TM) for Lung Biopsy Procedures

U.S. Food and Drug Administration (FDA) 510(k) clearance of its Last Inch Assessment(TM) (LIA) system, the world's first system to use silicon photonics imaging technology and software designed to ...