MedTech Spectrum

Article Name Regulatory

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

Innovent secures global licensing deal with Roche for DLL3 antibody drug

Partnership advances development of novel therapies targeting cancer treatment.

02nd January, 2025

FDA grants orphan drug status to MicuRx's MRX-5 for NTM infections.

Designation supports development of innovative treatment for nontuberculous mycobacterial infections.

02nd January, 2025

Spectral AI issues guidelines for retail investors on warrant exercise

Simplifying the Process for Exercising Publicly-Traded Warrants to Maximize Investor Participation.

01st January, 2025

Polyrizon files U.S. patent for innovative Hydrogel Nasal technologies.

New application highlights advancements in nasal protection and drug delivery solutions.

31st December, 2024

Microbot Medical ends 2024 with FDA submission for LIBERTY commercialization.

Company achieves major milestones, advancing its robotic surgical system toward market launch.

31st December, 2024

FDA approves injectable form of Bristol Myers Squibb’s cancer drug Opdivo

New formulation enhances delivery options for advanced cancer treatments.

30th December, 2024

Korean startup Neurophet secures US FDA 510(k) clearance for multiple sclerosis analysis with 'Neurophet AQUA'

Accelerating global expansion with cutting-edge technology targeting multiple sclerosis, a prevalent condition in North America and Europe

25th November, 2024

Momentis Surgical Secures FDA Clearance for Advanced Anovo® Robotic Platform, Setting New Standards in Single-Incision Surgery

The next-gen Anovo® system, featuring groundbreaking haptic feedback and multi-directional flexibility, enhances surgeon precision and expands the reach of robotic-assisted procedures in gynecology and beyond.

11th November, 2024