Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.
TYLER, Texas–(BUSINESS WIRE)– AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and Drug Administration.
Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion
Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.
The clearance poises the orthopedics company to be first to market with robotic-assisted shoulder replacement surgery.
For use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT).
ClearPoint Neuro (Nasdaq:CLPT) announced that the FDA cleared its ClearPoint 2.2 software with integrated Maestro Brain Modeling.
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system
The company’s OTC device, which costs nearly $300, will compete with consumer pulse oximeters that are widely available but lack FDA clearance.
SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial. The approved trial will evaluate the Company’s LIFT implant to treat later stage patellofemoral cartilage degeneration in adult patients.