MedTech Spectrum

Article Name Point of Care Testing

FDA Grants Breakthrough Status to CND Life Sciences’ Cutaneous Neurodiagnostic Test

The FDA's Breakthrough Devices Program is intended to expedite the development and FDA review of medical devices granted BDD

08th October, 2025

HNL Lab Medicine Introduces Self-Collected HPV Test

The self-collected option allows patients to collect their own sample in private, eliminating the need for a pelvic exam

01st October, 2025

PHASE Scientific Launches World’s Largest Clinical Study on Urine-Based Cervical Cancer Screening in China

The 17,000-woman study, led by Peking University Shenzhen Hospital, sets three world records and integrates PHASiFY™ DNA concentration technology with AI-powered diagnostics to advance scalable, non-invasive screening in line with WHO’s 2030 elimination goals.

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

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

Apollo Hospitals Launches Apollo Athenaa – Asia’s First Dedicated Cancer Centre for Women in New Delhi

The landmark centre, inaugurated by Delhi’s Chief Minister Smt. Rekha Gupta, sets a global benchmark in women-centric cancer care with a focus on dignity, privacy, and advanced treatment outcomes.

23rd September, 2025

NovaBone Unveils First Fully-Synthetic Bioactive Pre-Contoured Wedge at AOFAS 2025

Breakthrough bioactive glass device offers surgeons a safe, resorbable, and cost-effective alternative to metal implants, engineered to accelerate bone regeneration and streamline surgical workflow.

11th 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

Siemens Healthineers and Evident Partner with Klinikum Ludwigshafen to Deliver Fully Digital Pathology Workflow

Alliance integrates Siemens’ digital pathology solutions with Evident’s Pramana platform to modernize diagnostics, unify clinical workflows, and advance AI-driven personalised healthcare in Germany.

04th September, 2025

Caris Life Sciences Demonstrates Scientific Rigor with Clinical Validation of FDA-Approved MI Cancer Seek

MI Cancer Seek is the first and only test to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved CDx indications

18th August, 2025

ASP Unveils BIOTRACE™ Instant Read Steam System for Real-Time Sterility Assurance

New system empowers sterile processing departments with the fastest FDA-cleared readout on the market, enabling real-time decision-making and elevating operational efficiency.

08th August, 2025

Hyperfine’s Swoop® Portable MRI Deployed in Brain Clinic

Hyperfine Achieves Clinical Milestone Ahead of Plan With 100th Patient Enrolled in Neurology Office Study Using the Next-Generation Swoop® System

05th August, 2025

Advanced MedTech Drives Patient-Centred Innovation in Urology Across Asia

In conversation with MedTech Spectrum, Mr. Wong Yau Chung, Group CEO of Advanced MedTech Holdings, shares how the company is advancing kidney stone care, laser technologies, and digital platforms to address emerging urological challenges.

04th August, 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

TrilliumBiO and T-NeuroDx Partner to Advance Blood-Based Diagnostics for Early Alzheimer’s Detection

Strategic collaboration aims to accelerate validation and commercialisation of non-invasive tests, enabling earlier, more accessible diagnosis of Alzheimer’s disease

30th July, 2025