BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand. According to the Austin, Texas–based company, about half the time a patient enters the ER they don’t know, can’t communicate or aren’t carrying the wallet card listing the […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Abbott to update CardioMEMS to allow patients to track pulmonary artery pressure
The FDA approved an update to Abbott’s (NYSE: ABT) heart failure monitoring platform, which will allow patients to view their implant’s readings and receive personalized medication updates through an app. Abbott’s CardioMEMS system includes a wireless blood pressure sensor placed within the pulmonary artery, to catch early signs of worsening heart failure. Previously any changes […]
Edwards earns FDA approval for first-of-its-kind size-adjustable pediatric heart valve
Edwards Lifesciences earned FDA approval for its Autus size-adjustable heart valve, a surgical pulmonary heart valve for pediatric patients with congenital heart disease, the company announced today. The first-of-its-kind valve is designed to expand as the child grows, reducing the need for repeat open-heart surgeries. It’s also the first artificial heart valve approved in the […]
Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
Medtronic (NYSE:MDT) has secured a breakthrough designation from the FDA for a version of its drug-coated balloon aimed at unblocking arteries below the knee, following years of development. The In.Pact BTK catheter is slated for an international, randomized pivotal trial that plans to enroll about 400 participants with peripheral artery disease in the lower legs, […]
Medtronic gains regulatory wins for latest cardiac ablation software
Medtronic (NYSE:MDT) today announced regulatory green lights for its newest heart mapping and ablation software, supporting its fast-growing arrhythmia-treating cardiac ablation business. The Minnesota-run medtech secured an FDA clearance and a CE mark for its Affera Prism-2 cardiac mapping software. There was also a CE mark for its PulseSelect ProxBox adapter with proximity indicator software. […]
Intuitive receives CE mark for da Vinci 5 cardiac procedures
Intuitive (NASDAQ: ISRG) continues to get back to its roots, claiming a European approval for its da Vinci 5 system in minimally invasive cardiac procedures. After first being founded to chase robotic heart surgery — before a decades-long pivot into high-volume gynecologic, urologic and general procedures — Intuitive recently re-entered the space by picking up […]
Perfuze’s super-bore stroke catheter tops conventional, cyclic aspiration in bench study
Following FDA clearance earlier this year, Perfuze is putting forward new data comparing its super-bore aspiration catheter to conventional suction methods for removing stroke-causing blood clots, as well as the emerging approach of cyclic aspiration. The three-way benchtop study of the company’s Millipede88 catheter, tested with in vitro models of large vessel occlusions, was described […]
Corcym delivers first-in-human implant of Memo 4D Curve mitral repair ring
After completing a first-in-human implantation of its tricuspid system earlier this month, Corcym has announced another first placement designed for the heart’s mitral valve. The Memo 4D Curve broadens the company’s Memo surgical mitral repair platform, adding an open-ring configuration with a semi-rigid annuloplasty implant featuring a laser-cut nitinol cell structure. The device received FDA […]
FDA clears at-home dental dressing for non-surgical periodontal procedures
The FDA cleared a personalized wound dressing that users can apply themselves at home following certain periodontal procedures, including deep cleanings under the gums. Emanate Biomedical’s Perio PODS include single-use trays customized to each patient based on dental scans, and come preloaded with an engineered hydrogel. Worn twice daily for 30 minutes for up to […]
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary in-stent restenosis.” Cordis President of Americas […]
Autonomix taps former Medtronic FDA counsel head for board of directors
Autonomix Medical (Nasdaq:AMIX) has tapped Medtronic’s former chief regulatory counsel, Sandra Cohen Kalter, for its board of directors as it looks to advance its pipeline of catheters for mapping and treating the nervous system. Kalter has served as an advisor to Autonomix’s board for nearly a year. Now with her own seat, the company hopes […]
