Micro Interventional Devices today said it received FDA breakthrough device designation for its MIA-T percutaneous tricuspid annuloplasty system. The MIA-T system treats moderate to severe tricuspid regurgitation through a 12F catheter-based system. Get the full story on our sister site, Medical Tubing + Extrusion.
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
🫀 Narrow your focus with these categories:
Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
Medtronic beats The Street in Q4, Hugo robot wins IDE
Medtronic (NYSE:MDT) had much to tout with its pipeline as it released Street-beating fourth-quarter results. CEO Geoff Martha announced to analysts that FDA has granted the company’s much-anticipated Hugo robot an investigational device exemption approval. Medtronic is preparing to commence its Expand Uro trial in the U.S. to study Hugo in urologic procedures, Martha said […]
Varian wins FDA breakthrough nod for cardiac radioablation system
Varian announced today that it received FDA breakthrough device designation for its cardiac radioablation (CRA) system. Palo Alto, Calif.-based Varian, a recently acquired Siemens Healthineers company, developed the CRA system as a noninvasive therapy for select patients with refractory ventricular tachycardia (VT), according to a news release. VT, a fast, abnormal heart rate that could […]
Rapid Medical raises $50M to support its minimally invasive stroke treatments
Rapid Medical has completed an oversubscribed Series D financing worth $50 million, with money slated to support rapid worldwide commercialization of the Yokeam, Israel–based company’s minimally invasive stroke treatment tech. The money raised comes on the heels of FDA clearance of the company’s Tigertriever revascularization device to treat ischemic stroke. Touted as a new class […]
iRhythm wins FDA clearances for next-gen Zio monitor, AI capabilities
iRhythm Technologies (NSDQ:IRTC) announced that it received FDA 510(k) clearances for updates to its heart rhythm monitoring tech. San Francisco-based iRhythm’s first clearance came for a new and improved design of its flagship wearable Zio monitor and the second covered updated artificial intelligence (AI) capabilities, according to a news release. The Zio ambulatory cardiac monitoring […]
DTW Podcast: How AtriCure built a big business in Afib; A deep look into Abbott’s new Coronary imaging platform
In this week’s episode of the DeviceTalks Weekly Podcast, Dr. Nick West, CMO & divisional VP of global medical affairs at Abbott’s vascular business, discusses the European launch of the company’s new coronary imaging platform. Dr. West explains how the AI-powered platform works and the benefits it offers for decision-making during coronary stenting procedures. He […]
ITC takes up AliveCore patent complaint against Apple
The U.S. International Trade Commission (ITC) has agreed to investigate if Apple has imported devices that infringe three patents held by AliveCor. AliveCor filed the ITC complaint in April, alleging that Apple violated U.S. tariff law by importing certain Apple watches that infringe patents for its ECG technology. Mountain View, Calif.-based AliveCor wants the trade commission […]
Boston Scientific stent recall is Class I
The FDA announced today that it deemed Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall. Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. According to the FDA […]
Boston Scientific’s Acurate Neo performs well in latest trials
Boston Scientific (NYSE:BSX) touted positive results from multiple studies for its Acurate neo2 aortic valve system. Marlborough, Mass.-based Boston Scientific presented results from the investigator-initiated Early neo2 Registry and Ital-neo Registry studies at the EuroPCR 2021 meeting earlier this week, according to a news release. Results from the Early neo2 Registry of 554 patients across […]
Evolut TAVR just as good as open-heart surgery among younger people, Medtronic says
Medtronic (NYSE:MDT) today touted two-year outcomes for a trial comparing its Evolut TAVR system to open-heart surgery in younger people. Fridley, Minn.-based Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system went up against the gold standard of open-heart surgery in younger, healthier aortic stenosis patients in the trial, which had its results presented as a […]
Is renal denervation back as a high blood pressure treatment?
Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system. The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its own positive renal denervation study at the American […]