Article Name Regulatory

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...Read more

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....Read more

11th November, 2024



Limaca's Precision-GI granted CMS Transitional Pass-Through (TPT) Payment

To support access to newly approved innovative technologies...Read more

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?...Read more

08th November, 2024 | By Ankit Kankar | ankit.kankar@mmactiv.com 


PM virtually inaugurates Meril’s advanced medtech manufacturing facility in Gujarat under PLI Scheme

Focusing on Structural Heart, Vascular Interventions, Orthopaedics, and Endo Surgery...Read more

04th November, 2024


CDSCO becomes Affiliate Member of International Medical Device Regulators Forum

IMDRF membership will strengthen CDSCO’s medical device regulatory system...Read more

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...Read more

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...Read more

26th September, 2024



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