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Huxley Medical Announces FDA Clearance for Cellular-Enabled SANSA Home Sleep Apnea Test

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.

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Low-cost laparoscope designed for low- and middle-income countries

Despite its advantages, laparoscopic surgery remains largely inaccessible in low- and middle-income countries (LMICs) due to the high cost of equipment and other logistical challenges. To bridge this gap, researchers recently developed the KeyScope, an affordable laparoscope designed specifically for LMICs. As reported in Biophotonics Discovery, the KeyScope system was developed through an iterative human-centered design approach.

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Smart patch combines real-time health monitoring and drug delivery

A DGIST research team, led by Professor Kyung-In Jang, has developed a smart patch capable of real-time biometric signal monitoring and drug delivery. This patch integrates various sensors and a drug delivery system into a single unit using a foldable structure, enabling real-time cardiovascular health monitoring and immediate drug administration when necessary. The research team expects this technology to be widely applicable across multiple medical fields, including glucose management, pain relief, and chronic disease treatment.

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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.

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