Medtronic (NYSE:MDT) is recalling its HeartWare instructions for use and patient manual due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal. FDA today designated the recall as Class I, its most serious level of recall. The HeartWare ventricular assist device (HVAD) is used as a bridge to heart transplants in […]
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.
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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
InspireMD dips despite Street-beating Q1
InspireMD (NYSE:NSPR) shares slid today despite first-quarter results that topped the consensus forecast. The Tel Aviv, Israel-based company posted losses of -$3.2 million, or -53¢ per share, on sales of $1 million for the three months ended March 31, 2021, for a -64% bottom-line slide on a sales decline of -2.7%. InspireMD’s EPS of -53¢ […]
Shockwave Medical stock up nearly 21%
Shockwave Medical (NSDQ:SWAV) posted first-quarter results that beat the revenue consensus on Wall Street but missed earnings estimates. Shockwave Medical, though, also said it projects revenue for the full year to roughly triple to between $195–205 million — representing 188–202% growth over the prior year’s revenue. The Santa Clara, Calif.-based company — which has proprietary cardiovascular […]
Transit Scientific scoring sheath wins CE mark
Transit Scientific today said it received CE mark clearance for its XO Score scoring sheath platform. XO Score is designed for dilation of stenotic material in the peripheral vasculature, including popliteal, infrapopliteal and native or synthetic arteriovenous dialysis fistulae. The scoring and cutting technology in the device enables low-pressure lesion dilation and vessel prep with […]
Cardiovascular Systems sinks on missed Q3 earnings projections
Cardiovascular Systems (NSDQ:CSII) posted third-quarter results that beat the revenue consensus on Wall Street but missed on earnings projections. The St. Paul, Minn.-based company yesterday evening reported losses of –$6 million, or –15¢ per share, on sales of $63.27 million for the three months ended March 31, 2021 — versus a loss of nearly –$4 […]
ICU Medical reports 41% profit increase in Q1
ICU Medical (NSDQ:ICUI) posted first-quarter results yesterday that beat the overall consensus on Wall Street. The San Clemente, Calif.–based infusion therapy tech company reported profits of $23.7 million, or $1.09 per share, on sales of $318 million for the three months ended March 31, for a bottom-line gain of 41% on sales losses of -3.21% compared with […]
iRhythm Technologies up on mixed-bag Q1 results
iRhythm Technologies (NASDAQ: IRTC) posted first-quarter results that missed the earnings consensus on Wall Street but beat the revenue projections. The San Francisco-based company yesterday evening reported losses of –$27.8 million, or –95¢ per share, on sales of $74.3 million for the three months ended March 31 — versus a loss of –9.1 million, or […]
Silk Road Medical sinks despite Street-beating Q1, raised guidance
Silk Road Medical (NSDQ:SILK) shares took a big hit today despite first-quarter results that beat the consensus forecast. SILK shares were down -10% at $55.30 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -0.9%. The Sunnyvale, Calif.-based company posted […]
Penumbra slides on Street-beating Q1 results
Penumbra (NYSE:PEN) yesterday posted first-quarter results that beat the earnings consensus on Wall Street and matched sales estimates. The Alameda, Calif.-based company reported profits of $11.836 million, or 32¢ per share, on sales of $169.2 for the three months ended March 31, for a bottom-line gain of 730.6% sales growth of 23.2% compared with Q1 […]
Micro Medical Solutions wins FDA breakthrough device designation for vascular stent
Micro Medical Solutions today said it has received FDA breakthrough device designation for its MicroStent vascular stent. The stent is designed to maintain vessel patency, enhance wound treatment and improve quality of life and blood flow to reduce amputations and mortality for patients with critical limb-threatening ischemia (CLTI) from peripheral artery disease. “FDA breakthrough device […]
Medtronic wins CE mark approval for Evolut Pro+ TAVI system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system. Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut TAVI platform. It won U.S. FDA approval in 2019. The latest edition of the platform includes four […]