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. […]
Pre-Market Approval (PMA)
Medtronic wins FDA nod for ‘game-changing’ DBS device
Medtronic today announced FDA approval of its Percept RC deep brain stimulation system, the latest member of its Percept line of DBS devices. The medtech giant describes the Percept RC as the first DBS sensing-enabled rechargeable device. In a presentation at the J.P. Morgan Healthcare Conference earlier today, Chair and CEO Geoff Martha called it […]
Endotronix submits pulmonary artery sensor for FDA premarket approval
Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system. Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes. The Cordella system delivers proactive PA pressure data and non-invasive vital health data […]
Medtronic PulseSelect pulsed field ablation wins FDA approval
The FDA has approved the Medtronic PulseSelect pulsed field ablation (PFA) system, the device developer said today. PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval. The minimally invasive, cardiac ablation system is indicated for the treatment of […]
FDA approves Medtronic’s Symplicity Spyral renal denervation system
Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. [Update: Read more of our coverage from the weeks following the approval, including Medtronic’s lessons learned, what’s next for the technology, and other potential applications.] A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic […]
Recor Medical wins first FDA nod for renal denervation to treat hypertension
Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension. The long-awaited approval for the Otsuka Medical Devices portfolio company allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to adequately control a patient’s blood pressure. Paradise had looked the […]
Boston Scientific wins expanded indication for SCS system
The FDA has greenlit an expanded indication for the WaveWriter Alpha spinal cord stimulator systems from Boston Scientific . The approval now includes the treatment of painful diabetic peripheral neuropathy, a diabetes complication affecting the lower extremities. Diabetic neuropathy, a form of nerve damage often found in the legs and feet, is caused by prolonged […]
FDA review panel: Medtronic Symplicity Spyral RDN risks outweigh benefits
An FDA review panel voted against recommending approval of Medtronic’s Symplicity Spyral renal denervation (RDN) therapy for hypertension under the proposed indications. The panel unanimously said the minimally invasive catheter system is safe, but was nearly split on efficacy. With six members voting that the benefits outweighed the risk, six voting the other way and […]
Integra Lifesciences completes enrollment in DuraSorb monofilament mesh IDE study
Integra LifeSciences announced that it completed enrollment ints U.S. DuraSorb trial. The FDA investigational device exemption (IDE) clinical study evaluates DuraSorb in two-stage breast reconstruction. The bioabsorbable matrix-based monofilament mesh currently has FDA clearance to reinforce soft tissue where weakness exists. Princeton, New Jersey-based Integra said its study marks the first and only active, multi-center […]
Artivion gains FDA approval for PerClot, starts transfer to Baxter
Artivion today announced FDA premarket application (PMA) approval of its PerClot absorbable hemostatic system designed to control bleeding in specific surgical procedures. The Atlanta-based company will transfer full ownership to Baxter , following a sale agreement that occurred in July 2021. Artivion anticipates receiving an $18.75 million milestone payment under the terms of the agreement. […]
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result […]
