MedTech Spectrum

Article Name Clinical & Diagnostic

Baird Medical Gains Indonesian Regulatory Approval for Microwave Ablation Technology

Approval paves the way for broader adoption of Baird Medical’s minimally invasive treatment for tumor ablation, expanding access to advanced cancer care in Indonesia.

11th March, 2025

Beckman Coulter Secures FDA Clearance for DxC 500i Clinical Analyzer

The integrated clinical chemistry and immunoassay system enhances efficiency, streamlines lab workflows, and delivers accurate diagnostics in a compact design.

11th March, 2025

Lunit AI Boosts Cancer Detection in Largest Single-Reading Mammography Study

World’s first large-scale prospective study confirms AI-assisted single-reading mammography improves cancer detection, optimizes workflow efficiency, and reduces radiologist workload.

11th March, 2025

CLEW Launches AI-Powered Sepsis Virtual Unit to Strengthen SEP-1 Compliance

The new solution leverages real-time data and AI-driven insights to enhance early sepsis detection, optimize clinical workflows, and improve patient outcomes.

11th 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

Synergy Laboratories Introduces AI-Powered Genius™ Digital Diagnostics System for Advanced Cervical Cancer Screening

First in the Gulf Coast to launch Hologic’s FDA-cleared digital cytology system, enhancing diagnostic accuracy and expanding access to expert pathology insights.

05th 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

Sysmex America Expands Automated Hematology Line with XQ-320™ for Fast, Reliable CBC Testing

Designed for physician office labs and stat labs, the compact XQ-320™ delivers rapid results in under 60 seconds with enhanced diagnostic capabilities, minimal maintenance, and the industry-first BeyondCare℠ Quality Monitor.

04th March, 2025

Seonix Bio Launches SightScore™, the First Clinical PRS Test for Glaucoma in the U.S.

Early glaucoma detection, SightScore™ empowers eye care professionals with advanced genetic insights to identify high-risk individuals before symptoms appear, paving the way for proactive vision care.

03rd March, 2025

UK’s MYndspan Partners with MEGIN to Expand Access to High-Precision Brain Scans

Collaboration brings clinical-grade magnetoencephalography (MEG) technology to consumers, launching first brain health center in London.

28th February, 2025

Neuspera Medical’s Battery-Free Neuromodulation System Shows Promising Results in UUI Clinical Trial

Six-month study demonstrates 85% symptom reduction and strong safety profile, advancing a minimally invasive solution for urgency urinary incontinence treatment.

27th February, 2025

Addiction Prevention Coalition and DisposeRx Expand Opioid Education and Disposal Efforts in Alabama

The initiative strengthens opioid prevention across Alabama by providing communities with vital education and at-home medication disposal solutions to reduce misuse and accidental overdoses.

27th February, 2025

Allwin Medical Devices and Esco Forge Strategic Partnership to Strengthen IVF Solutions and Expand Global Reach

The collaboration enhances Esco's IVF instrument portfolio with Allwin's consumables, offering a comprehensive solution for IVF clinicians and embryologists while expanding market presence in India.

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

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