MedTech Spectrum

Article Name North America

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

Shoulder Innovations Launches InSet™ 70 Humeral Stem to Expand I-Series Portfolio

The bone-sparing implant, cleared for both anatomic and reverse shoulder arthroplasty, enhances surgical flexibility and patient outcomes while reinforcing the company’s leadership in shoulder care innovation.

23rd September, 2025

BD Partners with Henry Ford Health to Pioneer Automated Pharmacy of the Future

The collaboration introduces BD Rowa™ Vmax robotic technology to deliver 24/7 prescription access, streamline pharmacy operations, and empower staff to focus on patient-centred care.

23rd September, 2025

QuidelOrtho Expands QUICKVUE Portfolio with FDA-Cleared Influenza + SARS Rapid Test

The new CLIA-waived immunoassay enables simultaneous detection of influenza A/B and SARS-CoV-2 in just 10 minutes, supporting faster, cost-effective decision-making at the point of care.

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

Nicklaus Children’s Heart Institute Pioneers Bedside PDA Closures for Fragile Newborns Subheadline

The Institute, led by Dr. Shyam Sathanandam, is transforming neonatal cardiac care by delivering minimally invasive PDA closures directly in the NICU—eliminating transport risks and accelerating recovery for South Florida’s most vulnerable infants.

23rd September, 2025

Medtronic secures FDA approval for Altaviva device

The Implantable Tibial Neuromodulation (ITNM) device will expand treatment options for the 16 million people living with urinary urges and involuntary leaks

22nd September, 2025

Argá Medtech Announces Enrollments in COHERENT-AF IDE Clinical Trial

The COHERENT-AF trial will enrol up to 360 patients across clinical sites in the United States and Europe

19th September, 2025

Dornier MedTech America launches Hoover and AXIS II SLIM bar in kidney stone treatment

Together, the three devices streamline the procedure by combining effective stone treatment with rapid, controlled clearance

18th September, 2025

ZKR Orthopaedics Announces First Patella LIFT Surgeries on the East Coast at Hospital

The outpatient procedures were performed as part of an ongoing FDA IDE clinical trial

17th September, 2025

Merit Medical Embosphere Microspheres Achieve CE Mark for Genicular Artery Embolisation

Expanded indication provides patients with knee osteoarthritis with the benefits of Embosphere’s consistent, predictable, and effective clinical results

15th September, 2025

Nexus Spine's Patented Tranquil Interbody Implants Achieve Exceptional Outcomes

The results of this study suggest that Nexus Spine's patented technology amounts to a significant improvement over the competing devices

12th September, 2025

Neu Health Joins Global Incubator Programme, Advancing Precision Neurology for Parkinson's and Dementia Care

GIP acceptance builds on Neu's FDA clearance for Parkinson's tremor measurement and major U.S. health system pilots with entry into America's largest medical innovation hub

12th September, 2025

Mindray North America Joins Global Partnership with Mercy Ships to Transform Surgical Care

This collaboration further reinforces Mindray's mission to advance medical technologies to make healthcare more accessible

10th September, 2025

Altesa BioSciences and bioMérieux Collaborate for Altesa's Upcoming Phase 2B COPD Clinical Trial

Study will begin enrollment in Q1 2026 in the US and UK and leverage the BIOFIRE® SPOTFIRE® point-of-care diagnostics platform at U.S. sites

10th September, 2025

Medline announces new Prime Vendor agreement with West Calcasieu Cameron Hospital

New agreement to include the distribution of Medline custom sterile surgical packs

09th September, 2025

Steven Mickelsen, MD, Launches Del Medtech to Expand Pulsed Field Ablation Beyond the Heart

Del Medtech is developing transformative, single-use ablation devices designed to improve efficiency and patient outcomes

08th September, 2025

CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C

Robust 24-month complete response (CR) rate of 41.8 per cent observed for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) treatment

08th September, 2025