Uncategorized – Page 107 – Start Medical Product Development

OrthoPreserve Receives Both FDA Breakthrough Device Designation and Prestigious TAP Enrollment for Meniscus Implant to Revolutionize Knee Pain Treatment

January 29, 2025

RICHMOND, Va. and ATLANTA, Jan. 29, 2025 /PRNewswire/ — OrthoPreserve, a company developing orthopedic implant solutions, announced today it has been granted both a Breakthrough Device Designation and Total Product Life Cycle Advisory Program (TAP) enrollment from the U.S. Food & Drug Administration (FDA) for Defender, a meniscus replacement implant.

Surveillance tool can detect fast-spreading SARS-CoV-2 variants before they take off

January 29, 2025

Researchers have developed a powerful tool that can detect variants of SARS-CoV-2 with high transmission potential before they become widespread. This approach could significantly support public health efforts to control outbreaks and help identify new variants that need closer monitoring.

Stem-cell ‘heart patch’ shows promise for heart failure treatment

January 29, 2025

The heart patch is produced from induced pluripotent stem cells derived from heart muscle cell.

AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening

January 28, 2025

NEW YORK, Jan. 28, 2025 /PRNewswire/ — AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system captures high-quality images of the human eye, helping to address critical gaps in retinal disease screening through a portable and accessible solution.

Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer’s Disease Blood Test

January 28, 2025

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

January 28, 2025

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

January 28, 2025

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

January 28, 2025

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

January 28, 2025

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

January 28, 2025

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

Blog

- Uncategorized

OrthoPreserve Receives Both FDA Breakthrough Device Designation and Prestigious TAP Enrollment for Meniscus Implant to Revolutionize Knee Pain Treatment

Surveillance tool can detect fast-spreading SARS-CoV-2 variants before they take off

Stem-cell ‘heart patch’ shows promise for heart failure treatment

AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening

Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer’s Disease Blood Test

Blood test accurately detects colon cancer

Novel lab-on-chip platform promises to expedite cancer diagnoses

An injectable hydrogel for local bone densification offers hope for osteoporosis patients

Scientists develop novel adjuvant delivery system to enhance cancer vaccine effectiveness

FDA clears Instylla’s Tembo Embolic System