InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company’s C-GUARDIANS pivotal clinical trial. The trial evaluated the […]
Pre-Market Approval (PMA)
Philips launches Duo venous stent system with FDA approval
Philips today announced the first implant of its Duo venous stent system following FDA premarket approval. Duo, an implantable medical device, treats symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI). Amsterdam-based Philips added Duo to its portfolio when it acquired Vesper Medical in 2021. On June 11, Dr. Erin Murphy of the […]
FDA approves XStim spine fusion stimulator
Xstim announced today that it received premarket approval from the FDA for its Xstim spine fusion stimulator device. Irving, Texas-based Xstim designed its capacitively coupled device to emit a low-energy signal. This, in turn, promotes bone healing following spinal fusion surgery. The company plans to make the device commercially available in the second quarter of […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
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. […]
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 […]
