Tag:
Biotronik
Latest Headlines
Latest Headlines
St. Jude cardiac devices win CE mark approval
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.
Biotronik gains FDA's sign-off for defibrillator line
Germany's Biotronik won the FDA's sign-off for its Ilesto line of cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D).
Devicemakers plot paths out of CRM funk
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 nabs FDA nod for single-lead ICD
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 gets FDA nod for next-gen, MRI-friendly pacer
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 stent developer grabs $4.3M series B in crowded EU market
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's home monitor cuts unintended ICD shocks by 52%
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 targets FDA approval with stent trial
Biotronik has kicked off a multi-center investigational device trial for its Pulsar-18, targeting U.S. approval for its self-expanding device.
UPDATED: Biotronik's drug-coated balloon wows with promising 6-month results
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.
Biotronik wins FDA approval for next-gen ICD and CRT-D
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.
