Article Name Regulatory
Olympus Initiates Global Removal of ViziShot 2 FLEX Needles Following Safety Reports
The voluntary action affects devices manufactured before May 12, 2025, after reports of component detachment linked to patient injuries and one death, with Olympus reinforcing safeguards to prioritise patient safety.
23rd September, 2025
Techsomed Secures FDA 510(k) Clearance for BioTraceIO360 Kidney Ablation Indication
The expanded clearance extends BioTraceIO360 beyond liver applications to kidney procedures, advancing Techsomed’s vision of a multi-organ, AI-driven image-guided therapy platform that standardises minimally invasive cancer care.
23rd September, 2025
Tasso-SNBL Secures Japanese Certification for Self-Collection Blood Kit
Breakthrough approval supports home-based testing and strengthens access to care
10th September, 2025
Abbott’s Navitor™ Wins CE Mark Expansion, Offering Minimally Invasive Valve Replacement to Low- and Intermediate-Risk Patients in Europe
Backed by VANTAGE trial data unveiled at ESC Congress 2025 and published in JACC: Cardiovascular Interventions, Navitor now covers all surgical risk categories—while new ESC/EACTS guidelines also strengthen support for MitraClip™ and TriClip™ in mitral and tricuspid valve disease management.
01st September, 2025
DeepSight™ Technology Receives First FDA 510(k) Clearance for NeedleVue™ LC1 Ultrasound System
Bringing Clarity and Confidence to Ultrasound-Guided Interventional Procedures
14th August, 2025
Conformal Medical Raises $32M to Advance Next-Gen Stroke Prevention Device
Funding boost to support pivotal trial and pre-commercialization of CLAAS® AcuFORM™ LAAO system.
13th August, 2025
Dräger Atlan A350 Series Earns Highest U.S. Cybersecurity Clearance for Medical Devices
Authority to Operate (ATO) certification from the U.S. Department of Defense affirms Dräger’s leadership in safeguarding patient data, delivering a fully ATO-certified anesthesia portfolio trusted by hospitals worldwide.
12th August, 2025
Bracco Imaging’s SonoVue® Secures NMPA Approval for HyCoSy Use in China, Enhancing Non-Invasive Infertility Diagnostics
Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women.
06th August, 2025
Body Vision Medical Secures HSA Approval for AI-Powered LungVision Platform in Singapore
Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics.
06th August, 2025
BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology
BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys
05th August, 2025
The FDA Is Phasing Out Animal Testing. Our Replacements Must Catch Up Fast.
In April, Health Secretary Robert F. Kennedy Jr. announced plans to dramatically reduce animal testing at U.S. health agencies. The FDA followed with a commitment to phase out animal studies in areas like monoclonal antibody development, favoring in vitro systems and artificial intelligence instead.
04th August, 2025
BD Submits FDA Application for First At-Home HPV Test with Advanced Self-Collection and Robotic Lab Processing
Designed to detect more high-risk HPV strains than any test on the market, the BD Onclarity™ Assay empowers women with a discreet, non-invasive screening option and leverages full lab automation to ensure accuracy, efficiency, and expanded access to cervical cancer prevention.
04th August, 2025
MiRus Secures NTAP Approval from CMS for Breakthrough EUROPA® Cervical Spine System
Awarded for its proprietary MoRe® alloy-based 2.9 mm rod, the EUROPA® PCF System offers a low-profile, high-strength solution for cervical and upper thoracic spine surgery—now eligible for Medicare reimbursement under the New Technology Add-on Payment programme.
04th August, 2025
Veeva Systems Report Reveals Data Gaps and Manual Burdens Hindering Medtech Regulatory Progress
2025 Regulatory Affairs Benchmark finds half of medtech firms lack confidence in registration data quality, with most relying on manual processes—yet momentum grows for adopting automation, RIM systems, and AI to accelerate compliance and market access.
31st July, 2025
USPTO Issues Final Rejection of Rampart IC’s Patent Claims Following Egg Medical Challenge
Reexamination finds Rampart’s radiation shielding patent lacks novelty, validating Egg Medical’s stance and bringing resolution to a legal battle that had clouded the competitive landscape.
31st July, 2025
Alafair Biosciences Earns Dual FDA 510(k) Clearances for VersaCoat™ Flowable Hydrogel
VersaCoat, a syringe-deliverable soft-tissue protector, brings Alafair’s proven hyaluronic acid and alginate formula to complex surgical sites—expanding its impact in orthopedic, trauma, and sports medicine procedures.
31st July, 2025
ClariMed Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities
Milestone underscores ClariMed’s commitment to quality excellence and reinforces its position as a trusted partner in navigating complex global regulatory landscapes
30th July, 2025
How the FDA’s 510(k) Pathway and Risk-Based Oversight Are Shaping the Future of Medical Device Regulation
By aligning regulatory rigour with technological complexity, the FDA safeguards public health while accelerating access to life-changing medical innovations through adaptive pathways and total lifecycle vigilance
30th July, 2025
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