Abbott announced today that it received CE mark approval for its Assert-IQ insertable cardiac monitor (ICM). The ICM provides a new option for diagnostic evaluation and long-term monitoring in people experiencing abnormal heartbeats. It can detect hard-to-spot irregularities in heartbeats and help physicians determine the best treatment course. Assert-IQ received FDA clearance in May 2023, […]
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
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 […]
Former Neuropace CEO takes the helm at Revamp Medical
Revamp Medical this week announced it appointed Mike Favet as CEO, effective immediately. Favet joins the Netanya, Israel–based heart failure congestion management company with more than 20 years of executive-level experience. He most recently was CEO of Neuropace, where he led a commercial expansion and took the company public in 2021. “Mike brings a distinguished […]
Biotronik wins breakthrough nod for Freesolve BTK resorbable magnesium scaffold
Biotronik this week announced it received FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS). The Berlin, Germany-based cardiac rhythm company designed Freesolve for individuals suffering from chronic limb-threatening ischemia (CLTI). The newly launched device is not coronary artery lesions. “This breakthrough device designation for the Freesolve RMS for BTK treatment […]
J&J’s Abiomed has a Class I Impella labeling recall with 49 deaths related to issue
The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind. Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart. This recall (a correction and not a product removal) affects 66,390 Impella pumps […]
Elixir Medical wins FDA breakthrough designation for DynamX BTK implant
Elixir Medical today announced it received FDA breakthrough device designation for its DynamX BTK system for treating chronic limb-threatening ischemia. The Milpitas, California-based company designed the adaptive implant to treat narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). Elixir Medical said the DynamX Bioadaptor metallic device supports the […]
Health Canada licenses Medtronic Symplicity Spyral renal denervation system
Medtronic announced today that it received a license from Health Canada for its Symplicity Spyral renal denervation (RDN) system. The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated. Approval in Canada comes […]
Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold
Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
Conformal Medical reports ‘encouraging’ results for left atrial appendage occlusion device
Conformal Medical announced “encouraging” results when comparing its CLAAS implant to the Boston Scientific Watchman FLX. These left atrial appendage occlusion (LAAO) devices bring different things to the table. Made of foam, CLAAS features a cup design with an embedded nitinol skeleton covered by a fluoropolymer (ePTFE) cover. Watchman FLX’s nitinol frame is covered by […]
SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent. Along with the regulatory milestone, the company announced that it completed its Series A funding round. Tom Pepin, principal at Tapper Ventures, led the financing. NFL quarterback Jameis Winston is also one of the first investors in the company. […]
Edwards reports ‘excellent’ outcomes with Sapien TAVR
Edwards Lifesciences announced positive results from two real-world studies evaluating its Sapien transcatheter aortic valve replacement (TAVR) system. Results came from the TVT Registry data and continued to demonstrate strong outcomes. Edwards presented the data at Cardiovascular Research Technologies (CRT) 2024. A study of the latest TAVR technology, the Sapien 3 Ultra Resilia valve found […]