Category: Regulatory/Compliance
Sorin will begin clinical testing on its SonR cardiac assist device after the FDA grants a conditional investigational device exemption.
Sorin Group (BIT:SRN) said the FDA granted conditional approval for an investigational device exemption for its SonR cardiac resynchronization device.
The Italian medical device company said it will launch the Respond CRT trial to evaluate the SonR device in more than 1,000 U.S. patients with advanced heart failure.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
Egypt's Central Administration for Pharmaceutical Affairs (CAPA), the country's medical device market regulator, has published a series of updates and amendments to its registration requirements on its website.
Among the more significant changes are:
The FDA provides insight into the size of the mobile medical app market, the average time of review and more during Congressional hearings.
MASSDEVICE ON CALL — As the Congressional hearing on the FDA's oversight of medical apps came to a close, there were a number of insights into the so-called m-health world.
MobiHealthNews tallied the top 5 take-home lessons from the hearings, including estimates of the time it takes for a medical app to undergo FDA review and an estimate of when we'll see the agency's final medical app guidance.
The FDA denies rumors that the 2.3% medical device tax will apply to smartphones or tablets.
The FDA this week rejected the notion that the 2.3% medical device tax contained in the Affordable Care Act would apply to iPhones, tablets or other smartphone technology.
Rumors of the "iPhone tax" reached the House Energy & Commerce Investigations subcommittee, where Republican members asked the FDA for an explanation.
Ethicon wins 510(k) clearance for its new cordless Enseal tissue sealer.
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon won 510(k) clearance from the FDA for its next-generation Enseal tissue sealing device with a self-contained power source.
The FDA's Circulatory System Devices Panel was divided this week on recommending approval for Abbott Vascular's first-of-a kind MitraClip heart implant for the reduction of mitral valve regurgitation.
An FDA advisory panel yesterday narrowly recommended approval for the first-of-a-kind MitraClip heart implant made by Abbott (NYSE:ABT), designed to prevent blood from flowing backward across the mitral valve.
A pair of House Republicans promise to take a closer look at the FDA, calling for an independent advisory committee to help provide insight and point out areas of improvement at the federal watchdog agency.
A duo of House Energy & Commerce Committee Republicans announced this week that they plan to take a closer look at the FDA's life sciences initiatives, suggesting that the agency may need an advisory panel to watch its performance.
