MedTech Spectrum

Article Name Regulatory

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

Hesperos Unveils First Digital Twin of Human Disease with Organ-on-a-Chip Breakthrough

Landmark integration of in vitro organ-on-a-chip and computational modeling marks a pivotal advancement in disease simulation, drug testing, and personalized medicine.

23rd July, 2025

Canada Grants Patent to bioAffinity Technologies for CyPath® Lung Diagnostic Test

New patent strengthens global IP portfolio for noninvasive lung cancer detection platform, expanding bioAffinity’s reach into international markets

23rd July, 2025

Autonomix Medical Secures New U.S. Patent for Advancing Nerve-Targeted, Minimally Invasive Therapies

Patent strengthens company’s IP portfolio as it expands innovative treatments for chronic pain, oncology, and other high-need conditions

22nd July, 2025

Takeda Secures FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices

New devices designed to streamline and personalize HYQVIA® administration for patients receiving subcutaneous immune globulin therapy

22nd July, 2025

Medtronic Earns CE Mark for Expanded Use of MiniMed™ 780G Insulin Pump System

Approval now includes children as young as two, pregnant individuals, and people with type 2 diabetes across Europe

22nd July, 2025

Spirair Secures FDA Clearance for TurbAlign™ Bioabsorbable Nasal Implant

Innovative device designed to maintain sinus patency post-surgery, enhancing healing and patient comfort without the need for removal

22nd July, 2025

Johnson & Johnson’s TAR-200 for Bladder Cancer Granted FDA Priority Review

NDA for TAR-200 targets high-risk non-muscle invasive bladder cancer, highlighting potential to transform treatment for patients unresponsive to BCG therapy

21st July, 2025

Texas Cardiac Arrhythmia Institute Becomes First in U.S. to Use FDA-Approved Wireless System for Arrhythmia Treatment

St. David's Medical Center pioneers clinical use of innovative wireless EP solution, marking a new chapter in minimally invasive cardiac care.

21st July, 2025

ZEISS CLARUS 700 Gains Regulatory Nod in China, Expanding Ophthalmic Portfolio

The NMPA approval of the ZEISS CLARUS 700 represents a major leap forward in ultra-widefield retinal imaging, offering high-resolution, true color visualization to support early detection and management of complex eye diseases across China.

21st July, 2025