BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
NuVasive wins expanded FDA nod for Monolith corpectomy system
NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures. The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction […]
Subtle Medical wins FDA nod, CE Mark for SubtlePet AI-powered imaging system
Medical imaging tech developer Subtle Medical said today that it won both CE Mark approval in the European Union and FDA 510(k) clearance for its SubtlePET artificial-intelligence-powered positron emission topography imaging enhancement system. The SubtlePET system is designed to enhance images and reduce scanning times to improve overall patient experience during imaging procedures, the Menlo […]
Edwards wins FDA nod for next-gen HemoSphere platform
Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring. The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients. The system now includes the […]
Merit Medical wins FDA nod for EmboCube embolization gelatin
Merit Medical received FDA 510(k) clearance for its EmboCube embolization gelatin. EmboCube is used in the embolization of hypervascular tumors. It features uniformly cut cubes of gelatin foam that have been designed to address preparation concerns and inconsistent particle sizes that come with traditional gelatin foam sheets as an embolic. Embocube gets preloaded into a Medallion […]
ElectroCore wins cluster headache FDA 510(k) indication for GammaCore
ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system […]
Amsel Medical wins FDA nod for Endo Occluder
Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures. The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices. The Amsel Endo Occluder is a […]
FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances
The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness. The plan to move towards newer predicate devices is part of the federal watchdog’s larger plans to “modernize” its 510(k) pathway and make itself […]
FDA releases 510(k) modernization plans
The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria. In an official posting, FDA head Dr. Scott Gottliebb and […]
SIG Medical wins FDA nod for Advantage Rib fracture repair device
SIG Medical said this week it won FDA 510(k) clearance for its AdvantageRib anterior system, a rib fracture system. The newly cleared AdvantageRib anterior system includes anatomically contoured titanium plates intended to closely fit patient anatomy and screws, and is intended to be used through a traditional anterior approach. The system also features straight plates […]
Abbott wins CE Mark, FDA nod for DRG Invisible Trial neuromod system
Abbott (NYSE:ABT) said today that it won FDA clearance and CE Mark approval in the European Union for its DRG Invisible Trial System intended to allow patients with complex chronic pain conditions to receive a trial treatment with the company’s dorsal root ganglion stimulation system. Abbott’s DRG therapy targets the dorsal root ganglion, a structure adjacent to […]
- 1
- 2
- 3
- …
- 60
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube