MedTech News
Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units
INDIANAPOLIS, Jan. 29, 2025 /PRNewswire/ — Roche announced today that the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L). The National Lipid Association (NLA) recommends all adults measure their Lp(a) – often referred to as L-P-Little-A – at least once in a lifetime to help assess cardiovascular risk.
OrthoPreserve Receives Both FDA Breakthrough Device Designation and Prestigious TAP Enrollment for Meniscus Implant to Revolutionize Knee Pain Treatment
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
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
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
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
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.