FDA Expands Approval of Insightec’s Exablate December 27, 2022 The system first received FDA approval in 2016. Read More
FDA Approves Abiomed’s Impella ECP Pivotal Heart Pump for Clinical Trial December 27, 2022 Abiomed announced that the FDA has approved the company’s investigational Impella ECP, the world’s smallest heart pump, for a pivotal trial. Read More
Surglasses Gets 510(k) Clearance for Augmented Reality Spine Navigation System December 22, 2022 The Caduceus S system will be launched in the U.S. market in the first quarter of 2023. Read More
Empirical Spine Submits PMA for Outpatient Spine Stabilization Device December 22, 2022 The LimiFlex tether previously received Breakthrough Device status. Read More
FDA Approves Eterna for Chronic Spinal Pain Relief December 21, 2022 The system charges wirelessly, with as few as five recharges per year, the company said. Read More
BioPoly’s Lesser Toe System Cleared for Toe Joint Replacement December 20, 2022 This is the company’s second cleared implant to treat arthritis in the toes. Read More
Providence Medical Technology’s Fixation System Gains Expanded Clearance December 19, 2022 The expanded clearance was based on results from a study in which 96 percent of those receiving the procedure had their fusion issues resolved. Read More
FDA Clears Two Life Spine Lateral Fusion Systems December 19, 2022 The systems can be used separately or in combination. Read More
Qiagen’s Companion Diagnostic Approved for NSCLC December 16, 2022 This is the fourth FDA approval for the kit. Read More
FDA Clears Two RF Medical Radiofrequency Ablation Products December 15, 2022 The Myoblate system treats uterine fibroids as an alternative to hysterectomy. Read More
Denti.AI Software to Automate Patient Dental Records Cleared December 15, 2022 The software reduces dental chart production time by 70 percent. Read More
Nova Eye’s iTrackTM Advance Canaloplasty Device Won’t be Cleared by Dec. 31 December 14, 2022 The company acknowledged the “rigorous pathway” for FDA clearance. Read More