GE HealthCare today announced it will distribute Ionic Health’s nCommand Lite, now that the tech has secured FDA 510(k) clearance. Ionic Health designed nCommand Lite to support remote patient scanning, image viewing/review and real-time guidance from remote experts during scanning procedures. It aims to address staffing shortages in radiology departments. GE Healthcare will exclusively distribute […]
510(k)
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]
FDA clears self-driving mobile C-arm from Siemens Healthineers
Siemens Healthineers announced today that the FDA granted clearance for its Ciartic Move mobile C-arm with self-driving capabilities. Ciartic Move accelerates and standardizes 2D fluoroscopic and 3D cone-beam computed technology (CT) imaging. Working in hospitals and outpatient facilities, it enables consistent automated workflows and reduced imaging time. Siemens Healthineers designed the system to address the […]
Avail Medsystems tech sold to robotics startup founded by former Auris leaders
Medical robotics startup Mendaera has purchased the technology of Avail Medsystems and hired some of its employees, Mendaera co-founder and CEO Josh DeFonzo said in an exclusive interview. The deal includes “substantially all” of Avail’s assets, said DeFonzo, who offered new details on his company’s objectives as it exits stealth mode. He declined to disclose […]
Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems
Intuitive Surgical is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today. Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system. “We are planning for a limited launch starting in […]
FDA clears automated insulin delivery system from Sequel Med Tech
Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]
Intuitive wins FDA clearance for its next-gen da Vinci 5
Intuitive Surgical has secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system. The news, announced yesterday after market close, comes less than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the name of the new system in the process. (Here […]
FDA clears pulsed field ablation electrode tech from Pulse Biosciences
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system. The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. CellFX nsPFA’s percutaneous electrode system features a percutaneous needle […]
FDA clears Getinge’s cardiovascular surgery offering, company lanches new table, light in U.S.
Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools. The Gothenburg, Sweden-based company won 510(k) clearance for its Vasoview Hemopro 3. This adds to the company’s portfolio of endoscopic vessel harvesting (EVH) solutions. Getinge said it designed the system with customer centricity top-of-mind. It hopes […]
SurGenTec wins FDA nod for hydrophilic synthetic bone graft
SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft. OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received FDA clearance in 2020. SurGenTec said that, along with clearance, it can report the first implantations of the new graft as well. The new bone graft offers what the company […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]