FDA clears Femasys’ FemChec diagnostic device
September 9, 2024
Femasys today announced it received FDA 510(k) clearance for its FemChec contrast-generating device that checks fallopian tubal status.
Femasys today announced it received FDA 510(k) clearance for its FemChec contrast-generating device that checks fallopian tubal status.
DeepWell Digital Therapeutics (DTx) has won FDA 510(k) clearance of technology to be used in immersive media like video games for stress reduction and as an adjunctive treatment for high blood pressure.
CENTER VALLEY, Pa., Sept. 5, 2024 /PRNewswire/ — Odin Medical Ltd., an Olympus Corporation company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first cloud-based Artificial Intelligence (AI) technology designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures, the CADDIE™ computer-aided detection (CADe) device.
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.
The new MRI labelling extends the active scan time for Medtronic DBS systems.
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.
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.
ENGLEWOOD, Colo., Sept. 3, 2024 /PRNewswire/ — Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and rehabilitation, today announced FDA clearance of its new TensWave device