CardioFocus today announced a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China. Marlborough, Mass.–based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment for atrial fibrillation (AFib). Get the full story on our […]
Cardiovascular
Edwards’ low-BP prediction software gains FDA clearance
Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance. Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only […]
iRhythm CEO Mike Coyle steps down for personal reasons, stock slides
iRhythm Technologies (NSDQ:IRTC) announced that president & CEO Mike Coyle has resigned due to personal matters. San Francisco-based iRhythm said in a news release yesterday evening that CFO Douglas Devine will take over as interim CEO while the search for a permanent replacement for Coyle is conducted. The company’s board of directors formed a CEO […]
Medtronic implant found better at predicting AFib than external device
A Medtronic implant was three times better than an external monitor at detecting new atrial fibrillation in stroke patients, a new study says. The Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (PER DIEM) study pitted Medtronic’s Reveal Linq implantable device, which monitors for AFib over 12 months, against the Spiderflash-T external device made by […]
Cardiovascular Systems launches peripheral balloon catheter
Cardiovascular Systems (NSDQ:CSII) today said it has launched its OrbusNeich Jade percutaneous transluminal angioplasty over-the-wire balloon catheter in the U.S. Jade is an over-the-wire (OTW) balloon catheter for the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae and post-dilation of balloon-expandable and self-expanding stents. Get the full story on our sister site, Medical […]
LivaNova moves forward with heart valve business sale
LivaNova (NSDQ:LIVN) announced today that it completed the initial closing of the sale of its heart valve business to Gyrus Capital. In December, LivaNova announced its board’s unanimous approval of the divestiture of the heart valve business to enable the company to “sharpen its focus” within its primary platforms, such as neuromodulation and cardiovascular. According […]
Micro Interventional Devices tricuspid annuloplasty system wins FDA breakthrough device designation
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.
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 […]
