Article Name Regulatory
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
Johnson & Johnson receives US FDA Approval for the VARIPULSE pulsed field ablation platform
For the treatment of Atrial Fibrillation
07th November, 2024
Limaca's Precision-GI granted CMS Transitional Pass-Through (TPT) Payment
To support access to newly approved innovative technologies
07th November, 2024
Trump’s Comeback: What MedTech Needs to Brace For and Capitalize On
From Deregulation to Tax Cuts, Trump’s Policies Could Redefine the MedTech Landscape — But Are Companies Ready?
08th November, 2024
PM virtually inaugurates Meril’s advanced medtech manufacturing facility in Gujarat under PLI Scheme
Focusing on Structural Heart, Vascular Interventions, Orthopaedics, and Endo Surgery
04th November, 2024
CDSCO becomes Affiliate Member of International Medical Device Regulators Forum
IMDRF membership will strengthen CDSCO’s medical device regulatory system
03rd October, 2024
GE HealthCare announces US FDA approval of Flyrcado injection PET radiotracer for enhanced diagnosis of coronary artery disease
Has potential to expand clinician, patient access to PET MPI while offering higher diagnostic efficacy
27th September, 2024
Axonics receives regulatory approval for fourth-generation rechargeable SNM system in Australia
Expects to commence sales of the R20 to Australian customers in November
26th September, 2024
Olympus Corporations’ Odin Medical receives US FDA clearance for first cloud-based AI endoscopy system for colonoscopy
Device improves adenomas detected per colonoscopy
05th September, 2024
35North India Discovery Fund -II invests in ‘Global Care’ – Lavanya Medicare Solutions Pvt Ltd
Aim to bridge healthcare divides worldwide
03rd September, 2024
Fujitsu tackles 'drug loss' in Japan through accelerating clinical trial digitalisation
Strategic partnership with Paradigm to leverage cutting-edge clinical trial platform technology
26th August, 2024
Medline receives first-ever diamond-level HIRC resiliency badge for manufacturing
Highlights a resiliency in Healthcare Supply Chain
20th August, 2024
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