MedTech Spectrum

Article Name Regulatory

EyeYon Medical expands operations with New Subsidiary in China

The move aims to strengthen EyeYon’s presence in Asia and enhance access to its innovative ophthalmic solutions.

05th February, 2025

FDA approves Roche’s Susvimo as first continuous delivery treatment for Diabetes-Related Blindness

Susvimo becomes the only FDA-approved therapy offering continuous drug delivery for diabetic eye disease.

05th February, 2025

Gyder Surgical secures FDA 510(k) clearance for GYDER® Hip System

World’s first pin-less, image-less solution for precise acetabular cup positioning in anterior hip arthroplasty.

04th February, 2025

Median Technologies' eyonis™ LCS Achieves Primary Endpoint in RELIVE Trial

Successful results from the pivotal study pave the way for regulatory submissions in lung cancer screening.

03rd February, 2025

Intelligent Bio Solutions expands global reach with Drug Screening System upgrade

The enhanced system now supports multiple languages, improving accessibility for global drug screening operations.

03rd February, 2025

QR678® Partners with Spectra Medical to Expand Access Nationwide

The partnership aims to make QR678®'s advanced, non-surgical hair regrowth treatment more accessible across the country through Spectra Medical’s distribution network.

31st January, 2025

Vertex Secures FDA Approval for JOURNAVX™ (suzetrigine), a Novel Non-Opioid Treatment for Acute Pain

JOURNAVX™ introduces a first-in-class approach to managing moderate-to-severe acute pain, offering an alternative to traditional opioid therapies.

31st January, 2025

Ryoncil® commercial launch progress and upcoming product pipeline developments

The latest updates on the market rollout of Ryoncil® and insights into the company’s expanding pipeline of innovative therapies.

31st January, 2025

Bicycle Health achieves profitability and secures $16.5M to expand Virtual Opioid use Disorder Treatment

The funding will help scale access to telehealth-based opioid use disorder care across the U.S., improving patient reach and support.

30th January, 2025

Spectral AI completes Pediatric enrollment for U.S. Burn Pivotal Study in Emergency Departments

The study aims to advance AI-driven burn assessment technology for improved pediatric patient outcomes.

29th January, 2025

Zimmer Biomet to acquire Paragon 28 in Definitive Agreement

The acquisition aims to strengthen Zimmer Biomet’s position in the foot and ankle surgery market with Paragon 28’s specialized solutions.

29th January, 2025

FDA Approves LEQEMBI® IV Maintenance Dosing for Early Alzheimer’s Treatment

Lecanemab-irmb receives approval as a maintenance therapy, offering new hope for early-stage Alzheimer’s patients.

27th January, 2025

Strengthening India’s Healthcare Backbone: CDSCO’s Policy on Refurbished Medical Devices Paves Way for Domestic Innovation and Patient Safety

India Takes Steps to Address Healthcare Security by Backing CDSCO's Ban on Pre-Owned Medical Device Imports Amid 70% Import Dependency

20th January, 2025

Illuccix® Secures European Approval

Breakthrough imaging agent advances prostate cancer diagnostics across Europe.

17th January, 2025

Santhera gains Positive NICE Guidance for AGAMREE® in treating Duchenne Muscular Dystrophy

Santhera has begun launch preparations for AGAMREE® in UK with first sales expected in this quarter

16th January, 2025

IHS achieves approval for global distribution of Insignis™ Infusion System

Rigorous audit paves the way for international availability of advanced infusion technology.

16th January, 2025

Indian Startup RNT Health Insights Secures Second FDA Breakthrough Designation for AI-Driven Esophageal Cancer Detection Tool

The Chandigarh-based health-tech startup advances gastroenterological diagnostics with its innovative AI-assisted technology, aimed at improving early detection and survival outcomes for esophageal cancer patients.

07th January, 2025