Article Name Regulatory

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




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


National Health Authority and Maharashtra University of Health Sciences sign MoU to drive digital health education

Providing comprehensive understanding of Digital Health fundamentals to doctors and healthcare providers

13th August, 2024


A new medical device design CDMO to open in Ireland's Galway

Establishing a hub for cutting-edge medical technologies

13th August, 2024


SMT gains classification in the Italian National CONSIP tender

To supply TAVI devices in all Italian hospitals

08th August, 2024


Pneuma Systems’ infusion technology accepted by FDA's Safer Technologies Program (STeP)

Highly selective program by FDA for accelerated regulatory review process

12th August, 2024


CroíValve announces $16 million equity financing for developing novel transcatheter tricuspid device

To fund study evaluating performance of device in severe tricuspid regurgitation patients

07th August, 2024


US FDA clearance for PENTAX Medical’s DEC Duodenoscope

Compatibility with Advanced Sterilization Products’ STERRAD 100NX sterilizer

05th August, 2024


Battelle to guide medical device companies through regulations on ‘forever chemicals’

Battelle has been developing innovative solutions to advance the testing, analysis and destruction of PFAS

29th July, 2024


SpotSee’s HemoTemp II receives standards accreditation from AABB

A step further in ensuring supply chain integrity for blood during transit and storage outside blood banks

25th July, 2024


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