Route 92 Medical announced that it received FDA 510(k) clearance for its FreeClimb 70 reperfusion system for treating ischemic stroke. San Mateo, California-based Route 92 designed the reperfusion system with the FreeClimb 70 aspiration catheter. It also features a Tenzing 7 delivery catheter. The system enables physicians to treat patients experiencing acute ischemic stroke by […]
510(k)
Abbott wins duo of FDA clearances for CentriMag life support system
Abbott announced today that it received two FDA clearances for its CentriMag system for life support. The agency cleared the CentriMag blood pump for longer-term use in adults using the CentriMag system. These adults require extracorporeal membrane oxygenation (ECMO) to save their life. Longer-term support provides physicians more time to assess the next steps and […]
FDA clears surgical navigation system from Proprio
Proprio announced today that it received FDA 510(k) clearance for its Paradigm surgical navigation platform. Seattle-based Proprio designed Paradigm to replace traditional surgical navigation technologies. Using an advanced approach, it avoids the pitfalls that pull attention away from the patient and disrupt workflows. According to a news release, Paradigm is the first such system to […]
FDA clears Carescape Canvas patient monitoring platform from GE HealthCare
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Carescape Canvas patient monitoring platform. Carescape Canvas offers precise, flexible patient care. Together with Carescape One, it makes up part of an adaptable ecosystem set for scaling up and scaling down monitoring capabilities. This comes based on the acuity of each individual […]
FDA clears Neuspera Medical peripheral nerve stim
Neuspera Medical this week announced its ultra-miniaturized neurostimulator system received FDA clearance. The Neuspera system is a micro-implant that delivers neurostimulation therapy through a wireless platform, including a wearable transmitter and iPad-based clinician programmer. The company designed the system to provide peripheral nerve stimulation (PNS) in an ultra-miniaturized option to allow for a better patient […]
FDA clears iTrack Advance canaloplasty device from Nova Eye Medical
Nova Eye Medical announced today that it received FDA 510(k) clearance for its new iTrack Advance canaloplasty device. The FDA cleared iTrack Advance for microcatheterization and viscodilation to reduce intraocular pressure (IOP). It treats adult patients with primary open-angle glaucoma. Fremont, California-based Nova Eye designed its newest canaloplasty device to leverage the proprietary features of […]
FDA clears patient-specific resection for the Restor3d Axiom total ankle
Restor3d received FDA 510(k) clearance for its Axiom patient-specific resection (PSR) system for use with its Kinos Axiom Total Ankle system. Durham, North Carolina-based Restor3d additively manufactures the Axiom PSR from titanium alloy. The company said this makes it the first all-metal, patient-specific instrumentation system cleared for use with an ankle arthroplasty system. According to […]
FDA clears AI-enabled lung ultrasound tech from Butterfly Network
Butterfly Network (NYSE:BFLY) announced today that it received FDA 510(k) clearance for an AI-enabled auto B-line counter. Burlington, Massachusetts-based Butterfly Network develops handheld ultrasound technology. B-lines on an ultrasound scan appear as bright, vertical lines indicating wetness in the lung, associated with pulmonary air-space disease. That includes congestive heart failure, chronic obstructive pulmonary disease (COPD), […]
FDA clears Woven Orthopedic Technologies surgical screw enhancer
Woven Orthopedic Technologies announced recently that the FDA granted 510(k) clearance for its Ogmend implant enhancement system. Manchester, Connecticut-based Woven Orthopedics designed Ogmend for spine surgery. The implantable sleeve aids screw fixation in challenging scenarios. “We are thrilled to deliver surgeons a simple, reliable solution to help overcome one of the most prevalent yet least […]
FDA clears Viz.ai algorithm that detects abdominal aortic aneurysm
Viz.ai announced today that it received FDA 510(k) clearance for its algorithm that detects suspected abdominal aortic aneurysm (AAA). The company said in a news release that this marks the first FDA-cleared, AI-powered solution for detecting and triaging suspected AAA. Viz.ai’s AI algorithm automatically searches for the presence of an abdominal aortic aneurysm from any […]
Asensus secures pediatric indication for its robotic surgery system
Asensus Surgical announced today that FDA has cleared an expanded pediatric indication for its Senhance robotic surgery system. Research Triangle Park, North Carolina–based Asensus says Senhance is the first and only digital laparoscopic surgery solution for pediatric patients. During the company’s fourth-quarter earnings announcement early this month, it said it expected the pediatric indication this […]
