Champagne corks will be popping at Cameron Health as FDA’s expert panel review results in a vote in favour of its subcutaneously implanted S-ICD® device. FDA approval is expected to follow within 12 months.
FDA
HeartWare® Ventricular Assist System Gets FDA Panel’s Vote
Heartware’s Ventricular Assist Device was expected to get the FDA Circulatory Systems Advisory Panel support, so it’s no surprise that it’s happened. FDA approval is expected to follow.
Sweaty Palms At Cameron Health Today?
April 26th is FDA Circulatory Panel decision day for Cameron Health’s S-ICD device. Not much resting on it… only $150m.
FDA’s Damning Of EU Regulations: Fair Comment?
The FDA has chosen attack as its best form of defence this week as it adopts a very aggressively critical stance over EU regulatory failings. It’s a bit rich though isn’t it when data suggesting EU regs are harming patients seems to be thin on the ground.
In Who’s Interest Is FDA’s Global Charm Offensive?
FDA’s new report ostensibly focuses on patient safety… US patient safety that is. So it’s missionary work, but people of the rest of the world, who’s access to the newest medical technology is less restricted, might argue they’re fine as they are thanks.
St Jude Questions Hauser Paper And Demands Retraction
According to St Jude, Dr Robert Hauser’s paper, accepted for publication in the Heart Rhythm Journal is biased and inaccurate, comparing apples with pears and peddling conclusions it’s own analysis cannot reproduce from the data set. Watch this space.
Now FDA Issues Class I “Recall” For Thoratec Ventricular Assist Device
FDA draws attention to potential problems with Thoratec’s HeartMate II LVAS pump.
More Cold Water Poured On Consumer Reports’ “Dangerous Devices” Hyperbole
When it comes to Medical Device Regulation, a balanced assessment without fear nor favour is all we were looking for, so its refreshing to see someone else trying to counter the media frenzy.
Heart Blog Rather Sums It All Up
Thoughtful and insightful blog post from today on theheart.org
Surely Tougher Regs Must Be Trumped By Better Post Marketing Surveillance
Fence sitting or balanced view? Must Medtech always be the evil giant in all of this?
FDA Expert Panel To Convene In June Over Metal-On-Metal Hips
It looks like it’s invitation only for the FDA panel review meeting to be held in June, at which experts will discuss all aspects of the Metal-on-Metal hip disaster.
Media Assault On Medtech Continues
Let’s face facts. Medical device regulation is by definition imperfect, however much we fiddle with it. The world’s toughest regulator is apparently a pussycat allowing devices onto the market without such as a by-your-leave. If you believe the so-well-informed media.
J&J Selling Vaginal Mesh Without FDA Clearance Might Make A Good Headline, But Doesn’t Change Much
Vaginal Mesh problems are going to land at someone’s door and J&J’s looking like a soft target. It transpires the company decided to launch “Prolift” in 2005 as an “insignificant change” to a previous device, so didn’t feel the need to tell FDA about it.
Is FDA About To Clip Stryker’s Wingspan?
Stryker’s Wingspan Stent is up for FDA panel review on March 23rd. FDA’s Executive Summary, released today doesn’t auger well as results of clinical study don’t seem to support safety and efficacy claims.
Everflex: FDA Releases Summary Documents
FDA has now released summary information relating to last week’s newly US-cleared Everflex peripheral vascular stent from Covidien.
FDA Recall: Acclarent Inspira AIR™ Balloon Dilation System, Size 18X40mm
Acclarent’s voluntary recall of its Inspira Air™ balloon dilatation system has been formalised as a FDA Class 1 recall.