FDA clears surgical guidance system from Merit Medical
February 15, 2024
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system
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.
Abbott (NYSE: ABT)+
announced today that an FDA advisory committee ruled that the benefits of its TriClip outweigh the risks in treating tricuspid regurgitation (TR).
Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq AP-Dx. The digital pathology solution was cleared for the purpose of primary diagnosis.
Viz.ai announced that it received FDA 510(k) clearance for its Viz ICH Plus algorithm for providing volume measurements of brain bleeds.
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.
ROSWELL, Ga., Feb. 6, 2024 /PRNewswire/ — StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs’ position at its forefront.
Boston Scientific (NYSE: BSX)+
announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems.
Philips (NYSE: PHG)+
announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software.