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Industry hopes that new Russian device regulations would speed up the pace of registrations and approvals have paled as regulators struggle to create implementing guidance. The regulations took effect in January 2013, but have yet to be fully enacted. Read More
The UK’s healthcare cost-benefit watchdog is recommending implantable cardioverter defibrillators as a first-line treatment for people with previous serious ventricular arrhythmia, those with a familial cardiac condition with a high risk of sudden death and patients who have undergone surgical repair of congenital heart disease. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under a U.S. Food and Drug Administration final rule that takes effect April 10. Read More
Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More
The FDA granted AtheroMed’s Phoenix Atherectomy System 510(k) clearance to treat vessels below the knee in patients with peripheral artery disease. Read More