MedTech Spectrum

Article Name Regulatory

SkinCure Oncology Submits GentleBeam™ for FDA Clearance, Expanding Noninvasive Skin Cancer Treatment

GentleBeam™ aims to enhance Image-Guided SRT for nonmelanoma skin cancer, reinforcing SkinCure Oncology’s commitment to patient-centered, nonsurgical care.

10th March, 2025

Zimmer Biomet Wins FDA Nod for Metal-Safe Knee Implant

Zimmer Biomet Secures FDA Clearance for Persona® Revision SoluTion™ Femur, Expanding Options for Metal-Sensitive Knee Implant Patients

10th March, 2025

Optellum and Volpara Health Partner to Enhance AI-Driven Cancer Risk Assessment

Strategic agreement integrates Optellum’s AI-powered lung nodule analysis with Volpara’s early cancer detection tools, enabling a more comprehensive approach to patient risk evaluation.

05th March, 2025

NAMSA acquires WuXi AppTec’s US medical device testing operations to expand expertise and capacity

The acquisition strengthens NAMSA’s leadership in medical device biological safety testing, adding expertise, lab capacity, and scientific resources to support global manufacturers.

04th March, 2025

South Korea’s DeepQure Advances Global Clinical Trials for Innovative RDN Technology

Pioneering Extravascular Renal Denervation for Resistant Hypertension

04th March, 2025

Sebelas Miudella™ Becomes First FDA-Approved Hormone-Free IUD in 40 Years

Offering a long-acting, non-hormonal birth control option, the approval marks a significant milestone in expanding contraceptive choices for individuals seeking hormone-free alternatives.

03rd March, 2025

1 in 3 at Risk: Cardiologists Urge Global Action on Pulse Day to Tackle Silent Epidemic of Heart Rhyhm Disorders

With cases of atrial fibrillation and other heart rhythm disorders rising rapidly, the European Heart Rhythm Association (EHRA) calls for greater awareness and early detection—starting with a simple pulse check on 1 March.

03rd March, 2025

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.

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.

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.

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

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

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.

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.

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-escalation.

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.

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, multi-night testing and seamless remote monitoring. 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, multi-night testing and seamless remote monitoring.

21st February, 2025

Medcrypt Enhances Helm to Help Medical Device Manufacturers Streamline Cybersecurity Compliance

With advanced SBOM management, automated vulnerability tracking, and FDA-ready reports, Helm reduces risk, lowers costs, and accelerates regulatory approval for medical device manufacturers.

20th February, 2025