FREMONT, Calif., Sept. 5, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the Persona® The Personalized Knee System® from Zimmer Biomet.
Fresenius Medical Care announced today that it launched the newest version of its home hemodialysis (HHD) machine, the NxStage Versi HD with GuideMe software.
The new MRI labelling extends the active scan time for Medtronic DBS systems.
PLANO, Texas, Sept. 4, 2024 /PRNewswire/ — Vesalio announces the U.S. commercialization of pVasc™ Thrombectomy System for non-surgically removing peripheral occlusions. pVasc targets the full range of embolisms from soft, acute clots to fibrin-rich, calcified ones, enabling a fast and safe removal. Its unique Drop Zone™ technology traps, retains and securely removes thrombus to restore flow in patients suffering from acute limb ischemia (ALI) and other conditions related to peripheral artery disease (PAD).
SAN FRANCISCO, Sept. 4, 2024 /PRNewswire/ — Big Health, a leading developer of digital mental health treatments, has been granted clearance by the U.S. Food and Drug Administration (FDA) for its digital therapeutic, DaylightRx. DaylightRx is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. DaylightRx is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient’s GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
AngioDynamics (Nasdaq:ANGO) announced today that it received CE mark approval for its Auryon atherectomy system.
EYSINS, Switzerland, Sept. 3, 2024 /PRNewswire/ — At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. We are excited and proud to announce AliveDx has received IVDR-CE mark certification for its multiplexed MosaiQ AiPlex™ CD microarray immunoassay, designed to improve the accuracy and speed of diagnosing celiac disease
BOSTON and SHANGHAI, Sept. 3, 2024 /PRNewswire/ — Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108, a novel one-time intravitreally delivered gene therapy for the treatment of Retinitis Pigmentosa (RP).
PARIS, Sept. 3, 2024 /PRNewswire/ — European MedTech startup AZmed, recognized as a leading company in AI for medical imaging, today announced that its Rayvolve solution has received 510(k) clearance from the Food and Drug Administration (FDA) for detecting fractures on pediatric X-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection, positioning Rayvolve as a top-performing solution for detecting fractures in adult and pediatric patients. The clearance was supported by an independent study conducted with SimonMed Imaging, one of the largest outpatient imaging providers in the U.S.
BELFAST, Northern Ireland, Sept. 3, 2024 /PRNewswire/ — B-Secur, a leader in advanced biosensing technology, proudly announces the FDA clearance and launch of HeartKey® Rhythm, a suite of electrocardiogram (ECG) algorithms and analytics designed to enhance clinical confidence, streamline industry efficiency, and improve outcomes for cardiac patients.