MedTech Spectrum

Article Name Regulatory

Body Vision Medical Secures HSA Approval for AI-Powered LungVision Platform in Singapore

Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics.

06th August, 2025

BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology

BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys

05th August, 2025

The FDA Is Phasing Out Animal Testing. Our Replacements Must Catch Up Fast.

In April, Health Secretary Robert F. Kennedy Jr. announced plans to dramatically reduce animal testing at U.S. health agencies. The FDA followed with a commitment to phase out animal studies in areas like monoclonal antibody development, favoring in vitro systems and artificial intelligence instead.

04th August, 2025

BD Submits FDA Application for First At-Home HPV Test with Advanced Self-Collection and Robotic Lab Processing

Designed to detect more high-risk HPV strains than any test on the market, the BD Onclarity™ Assay empowers women with a discreet, non-invasive screening option and leverages full lab automation to ensure accuracy, efficiency, and expanded access to cervical cancer prevention.

04th August, 2025

MiRus Secures NTAP Approval from CMS for Breakthrough EUROPA® Cervical Spine System

Awarded for its proprietary MoRe® alloy-based 2.9 mm rod, the EUROPA® PCF System offers a low-profile, high-strength solution for cervical and upper thoracic spine surgery—now eligible for Medicare reimbursement under the New Technology Add-on Payment programme.

04th August, 2025

Veeva Systems Report Reveals Data Gaps and Manual Burdens Hindering Medtech Regulatory Progress

2025 Regulatory Affairs Benchmark finds half of medtech firms lack confidence in registration data quality, with most relying on manual processes—yet momentum grows for adopting automation, RIM systems, and AI to accelerate compliance and market access.

31st July, 2025

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.

31st July, 2025

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.

31st July, 2025

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

30th July, 2025

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

30th July, 2025

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.

28th July, 2025

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

25th July, 2025

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.

25th July, 2025

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

24th July, 2025

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.

24th July, 2025

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

24th July, 2025

The FDA Is Phasing Out Animal Testing

As regulatory shifts accelerate, next-generation non-animal models must rapidly evolve to ensure safety, efficacy, and innovation in human drug development.

23rd July, 2025

Rebuilding the Drug Repurposing Pipeline with Better Data

How high-quality, integrated datasets are transforming drug repurposing from opportunistic discovery to systematic innovation in therapeutic development.

23rd July, 2025