Tag

Renal Denervation

All articles tagged with #renal denervation

medical-technology2 years ago•7 min saved

"2023: A Year of Groundbreaking Medtech Trends, Treatments, and Approvals"

The top medtech trends of 2023 included the rise of artificial intelligence in medical devices, the popularity of GLP-1 weight loss drugs, the ongoing Philips Respironics CPAP recall, advancements in diabetes technology, competition in surgical robotics, the integration of AI in healthcare, unexpected shutdowns in the industry, major leadership changes, the approval of pulsed field ablation systems, and the long-awaited clearance of renal denervation systems by the FDA. Medtech companies also faced challenges such as layoffs, reorganizations, and supply chain issues.

via Mass Device|

#artificial-intelligence #glp-1-drugs #medical-technology

healthcare2 years ago•7 min saved

FDA Panel Rejects Medtronic's Symplicity Spyral RDN

An FDA review panel has voted against recommending approval of Medtronic's Symplicity Spyral renal denervation (RDN) therapy for hypertension, stating that the risks outweigh the benefits. While the panel unanimously agreed that the catheter system is safe, they were divided on its efficacy. The panel chair cast the deciding vote against FDA approval. Medtronic's RDN trials have failed to meet the primary endpoint for efficacy, but the company remains hopeful and will work with the FDA to address the panel's concerns. The FDA review panel also supported the approval of a competing RDN technology developed by ReCor Medical.

via Medical Design & Outsourcing|

#blood-pressure #fda #healthcare

healthcare2 years ago•1 min saved

FDA Panel Supports Otsuka and ReCor's Blood Pressure Treatment Devices

A panel of advisers to the US FDA has recommended the use of a blood pressure treatment device made by Otsuka Holdings' unit, ReCor, for renal denervation surgery. The device, which sends ultrasound energy to burn nerves that control blood pressure, was unanimously backed for safety by all 12 panel members, with eight voting in favor of its effectiveness. The panel recommended the device as a possible add-on therapy to reduce blood pressure, not as a replacement for medications. If approved, ReCor plans to initiate a post-market study registry to evaluate the long-term data of the surgical device.

via Reuters|

#blood-pressure-treatment #fda #healthcare