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 […]
510(k)
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 […]
FDA clears new radiotherapy systems from Siemens Healthineers’ Varian
Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging. The Siemens Healthineers company designed HyperSight to empower clinicians to accurately tailor treatments to individual patients. This helps improve patient outcomes, thanks to new capabilities and workflows across the company’s linear accelerators. HyperSight allows clinicians to […]
FDA clears sacroiliac joint fusion device from Nevro
Nevro (NYSE:NVRO) announced today that the FDA cleared its sacroiliac (SI) joint fusion device without the need to include an accompanying screw. Redwood City, California-based Nevro plans to market this device as Nevro1, without the need for the NevroFix screw. The system aims to immediately transfix the SI joint, allowing the opportunity for long-term fusion. […]
How medtech could be affected by a U.S. government shutdown
Editor’s note: This article originally ran on September 29, 2023. It was updated on February 27, 2024 to reflect new staffing contingency plans and which departments will be affected by the March 1 shutdown. Congressional leaders over the weekend did not come to an agreement on legislation to fund several government agencies, including the FDA. […]
FDA clears ROSA Shoulder robotic surgery system from Zimmer Biomet
Zimmer Biomet announced today that it received FDA 510(k) clearance for its ROSA Shoulder robotic-assisted surgery system. The company says this marks the clearance of the world’s first robotic surgery system for shoulder replacement. It’s also the fourth application for the ROSA (Robotic Surgical Assistant) portfolio, which includes the ROSA Knee and ROSA Hip. Zimmer […]