Zimmer Biomet Holdings has nabbed U.S. FDA clearance for the ROSA Shoulder System, a robotic assistant for shoulder replacement surgeries, providing surgeons with flexibility, improved placement accuracy, and data-driven decision-making capabilities.
Tag: FDA clearance
The FDA has cleared Telesair’s Bonhawa High Flow Oxygen Therapy system, which is designed to enhance treatment of patients with respiratory insufficiency.Read More
The FDA granted clearance to HistoSonics Histotripsy therapy platform for non-invasive destruction of liver tumors using focused ultrasound.Read More
Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.Read More
Insight Medbotics has received U.S. FDA 510(k) clearance for its MRI-compatible IGAR robot for breast biopsy indications.Read More
Limaca Medical’s Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.Read More