Regulatory

USPTO Issues Final Rejection of Rampart IC’s Patent Claims Following Egg Medical Challenge

Reexamination finds Rampart’s radiation shielding patent lacks novelty, validating Egg Medical’s stance and bringing resolution to a legal battle that had clouded the competitive landscape....

Alafair Biosciences Earns Dual FDA 510(k) Clearances for VersaCoat™ Flowable Hydrogel

VersaCoat, a syringe-deliverable soft-tissue protector, brings Alafair’s proven hyaluronic acid and alginate formula to complex surgical sites—expanding its impact in orthopedic, trauma, and sports medicine procedures....

ClariMed Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities

Milestone underscores ClariMed’s commitment to quality excellence and reinforces its position as a trusted partner in navigating complex global regulatory landscapes ...

How the FDA’s 510(k) Pathway and Risk-Based Oversight Are Shaping the Future of Medical Device Regulation

By aligning regulatory rigour with technological complexity, the FDA safeguards public health while accelerating access to life-changing medical innovations through adaptive pathways and total lifecycle vigilance...

Stereotaxis Secures FDA Clearance for MAGiC Sweep Catheter

New magnetic ablation catheter designed to enhance precision and reach in robotic electrophysiology procedures across the U.S....

Geneoscopy Secures FDA Approval for New At-Home Stool Collection Method

Simplified Process Aims to Boost Participation in Colorectal Cancer Screening and Improve Early Detection Rates...

UK Seizes Strategic Opportunity in India Through Trade Deal Tied to Atmanirbhar Bharat

A landmark trade pact strengthens Britain’s foothold in India’s booming self-reliant economy, creating new export, investment, and manufacturing opportunities for UK enterprises....

Opus Genetics and Global RDH12 Alliance Unite to Accelerate Gene Therapy for Childhood Blindness

Collaboration aims to advance RDH12-focused treatments for inherited retinal diseases, offering hope to children affected by vision loss worldwide...

Roche Secures CE Mark for Alzheimer’s Blood Test

New minimally invasive diagnostic aids in ruling out Alzheimer’s disease early, expanding access to timely and accurate neurological assessments across Europe....

Philips Secures FDA Clearance for Image-Guided Navigation Technology in Prostate Cancer Care

Breakthrough Minimally Invasive Solution Enhances Precision in Targeted Therapy Procedures, Supporting Improved Outcomes in Prostate Cancer Treatment...