Analogic wins FDA clearance for handheld Sonic Window vascular ultrasound
April 9, 2014 by Brad Perriello
Analogic said it won 510(k) clearance from the FDA for its handheld Sonic Window ultrasound device, designed to help caregivers view the vasculature to guide peripheral IV placement.
Peabody, Mass.-based Analogic said the Sonic Window “provides direct visualization of structures beneath the skin in real time to effectively guide clinicians placing peripheral IVs.” Read more
Medtronic wins CE Mark for Evera MRI SureScan ICD
April 9, 2014 by Brad Perriello
Medtronic said it won CE Mark approval in the European Union for the world’s 1st market-cleared implantable cardiac defibrillator that’s safe for full-body magnetic resonance imaging scans, its Evera MRI SureScan ICD.
The Evera device is slated for an immediate launch in Europe, according to a press release. Read more
September 2014 compliance deadline for Indian medical device labeling rules
April 11, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
India’s drug and medical device market regulators will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014.
The Drugs Controller General’s (India) Central Drugs Standard Control Organization (CDSCO) currently requires “India-specific” labeling to be attached to imported devices at their Indian ports of entry by distributors. India-specific labeling information should include importer and/or distributor names and Import License numbers. Read more
FDA expands indication for Medtronic pacemakers, defibs
April 11, 2014 by Brad Perriello
Medtronic said the FDA expanded the indication for some of its cardiac rhythm management devices to include bi-ventricular pacing in certain heart failure patients.
The FDA nod for Medtronic’s cardiac resynchronization therapy-pacemakers and cardiac resynchronization therapy-defibrillators is for patients with atrioventricular block and left ventricular systolic dysfunction, according to a press release. Read more
Draft FDA report proposes U.S. health technology framework
April 10, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
A new draft report by the US Food and Drug Administration proposes establishing a nationwide framework for regulating health information technology and medical devices. The FDA’s new proposals would involve three federal agencies (The FDA, Federal Communications Commission and the Office of the National Coordinator for Health Information Technology) in oversight of mobile medical apps and related technologies, and are intended to coordinate the roles of those regulators.
The FDA report emphasizes a health IT framework based on product functionality rather than platform – whether a device uses a mobile, installed or cloud-based platform is less important than what it does, according to the agency. Read more
