MedTech News

Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer’s Disease Blood Test
BREA, Calif., Jan. 28, 2025 /PRNewswire/ — Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p‑Tau217/β-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer’s disease.

Blood test accurately detects colon cancer
An experimental blood test can effectively and accurately detect colon cancer in middle-aged folks and seniors, a new study says. The research is published in the Journal of Clinical Oncology.

Novel lab-on-chip platform promises to expedite cancer diagnoses
In Physics of Fluids, a pair of researchers at the K. N. Toosi University of Technology in Tehran, Iran, propose a novel system that uses standing surface acoustic waves to separate CTCs from red blood cells with unprecedented precision and efficiency. The platform that Afshin Kouhkord and Naser Naserifar developed integrates advanced computational modeling, experimental analysis, and artificial intelligence algorithms to analyze complex acoustofluidic phenomena.

An injectable hydrogel for local bone densification offers hope for osteoporosis patients
Pioletti and colleagues at EPFL start-up flowbone have developed an injectable hydrogel that targets rapid, localized increase in bone density. The team, in collaboration with Vincent Stadelmann at the Schulthess Klinik, Zurich, have recently reported a novel therapy that combines these hydrogel injections with traditional systemic drugs.

Scientists develop novel adjuvant delivery system to enhance cancer vaccine effectiveness
Researchers at the Terasaki Institute for Biomedical Innovation have developed an innovative delivery system that could significantly improve the effectiveness of peptide-based cancer vaccines, according to a study published in Advanced Functional Materials.

FDA clears Instylla’s Tembo Embolic System
Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System.

Norlase Receives FDA 510(k) Clearance and CE Mark for LYNX™ Pattern Scanning Laser Indirect Ophthalmoscope
BALLERUP, Denmark and REDWOOD CITY, Calif., Jan. 27, 2025 /PRNewswire/ — Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for Norlase® LYNX™, the world’s first and only pattern scanning laser indirect ophthalmoscope.

Innovative voice-based approach enables early detection of Alzheimer’s disease
A multi-task learning framework, DEMENTIA, has been developed by Prof. Li Hai and his team at the Hefei Institutes of Physical Science of the Chinese Academy of Sciences, to improve the early detection and assessment of Alzheimer’s disease (AD). The research was recently published in the IEEE Journal of Biomedical and Health Informatics.