Regulatory

Arcuro Medical Secures FDA 510(k) Clearance for SuperBall-RC™ Rotator Cuff Repair System

New device simplifies graft fixation, enhancing rotator cuff repair outcomes with a planned launch in 2025....Read more

28th February, 2025


OrthoNovis Secures FDA Clearance for BPS Wrist Fracture System

The 510(k) clearance enables OrthoNovis to enter the U.S. orthopedic fracture fixation market with its innovative locking wrist plates, advancing treatment options for distal radius fractures and fusions. ...Read more

26th February, 2025


Averto Medical’s ColoSeal™ Wins FDA Breakthrough Device Designation for Colorectal Surgery

Minimally invasive ICD system aims to eliminate temporary ostomies, improving recovery and quality of life for patients undergoing colorectal surgery....Read more

26th February, 2025


Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...Read more

25th February, 2025


Japan Approves Sarclisa-VRd for Newly Diagnosed Multiple Myeloma Patients

Regulatory green light follows IMROZ Phase 3 study results showing significant progression-free survival benefit...Read more

25th February, 2025


CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Solutions Across Europe

With CE Mark approval, CathVision’s AI-powered ECGenius System is set to launch in the European market, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....Read more

25th February, 2025


EMA Approves Takeda’s TAKHZYRO Pre-Filled Pen for Subcutaneous Administration in Adolescent and Adult HAE Patients

The new 2 mL pre-filled pen option expands individualized treatment choices for hereditary angioedema (HAE) patients, reinforcing Takeda’s commitment to reducing disease burden and improving quality of life....Read more

25th February, 2025


IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-e...Read more

25th February, 2025


Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....Read more

24th February, 2025


South Korea’s PranaQ Secures FDA Clearance for AI-Powered Sleep Apnea Wearable, Backed by NAVER D2SF

With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible...Read more

21st February, 2025


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