St. Jude Medical gained a pivotal CE mark for two next-generation lines of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, advancing in Europe even as its rivals win U.S. approval for competing devices.
Germany's Biotronik won the FDA's sign-off for its Ilesto line of cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D).
Cardiac rhythm management isn't exactly a growth industry. Across the world, medical device companies are dealing with stagnant demand, pricing pressures and reimbursement cuts for pacemakers and...
Biotronik got the FDA's final approval on Lumax 740 DX, a first-in-class single-lead ICD designed to treat atrial fibrillation that the company says could vastly improve care for patients.
Medtronic gained FDA approval for what will become its second MRI-friendly pacer in the United States, and only the second device of its kind to gain a regulatory nod here.
Swiss coronary stent developer Qvanteq is reeling in more than $4.3 million in series B financing, representing the emergence of yet another stent player in an intensely competitive European market.
Biotronik is touting positive data for its Home Monitoring device, reporting that its tech, designed to keep tabs on ICD patients, reduces inappropriate shocks by 52% compared to traditional in-office follow-ups.
Biotronik has kicked off a multi-center investigational device trial for its Pulsar-18, targeting U.S. approval for its self-expanding device.
Biotronik says an ongoing clinical study has generated promising 6-month results using its Passeo-18 Lux drug-coated balloon to treat leg blood clots, compared to standard balloon angioplasty.
The competition to gain market share with next-generation ICD and CRT-Ds just got tougher. German device giant Biotronik won FDA regulatory approval for its new Lumax 740 implantable cardioverter defibrillators and cardiac resynchronization therapy devices.