VADUZ, Liechtenstein, Feb. 12, 2025 /PRNewswire/ — Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, is pleased to announce that the FDA has accepted Module 1 of the company’s premarket approval (PMA) application, and that this module is now considered closed.

STAMFORD, Conn., Feb. 11, 2025 /PRNewswire/ — Neuvotion, Inc. is an early-stage medical device company developing AI-driven neuromodulation technologies and products for use in the neurorehabilitation, brain-computer interface (BCI), and physical therapy markets. Neuvotion has received FDA 510(k) clearance for their first product, NeuStim™, a non-invasive, surgery-free wearable that electrically stimulates muscles dynamically and with high-precision.

Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system.

ATLANTA, Feb. 5, 2025 /PRNewswire/ — Huxley Medical, a commercial-stage medical technology firm focused on streamlining detection of sleep and heart disorders, announced that the US Food and Drug Administration (FDA) has cleared the SANSA home sleep apnea test to begin using cellular data upload capabilities. This breakthrough eliminates the need for Bluetooth pairing or smartphone apps commonly required to transmit test data to physicians, addressing a common source of failed home testing, while simplifying the diagnostic process for patients and providers alike.

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.

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.