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.

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.

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.

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