St Jude medical is taking the initiative over more of its leads in which so-called externalisation can result in problems, by issuing a physician advisory letter.
Regulatory
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.
UK Legalist’s Perspective On Medical Devices Regulatory Reform Post-PIP
Don’t reform medical device regulations as a knee jerk reaction to the PIP scandal, says lawyer. We agree. But metal-on-metal hips might tell us more about what we should be looking for in a regulatory regime.
Heart Blog Rather Sums It All Up
Thoughtful and insightful blog post from today on theheart.org
Medical Device Alert: Finsbury Mitch TRH Cup/Heads Combined With Stryker Accolade Femoral Stems
UK MHRA singles out specific combinations of hip/stem for attention, this alert proving the value of the data in England and Wales Joint Registry.
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 Clears MATRx™ Device, Which Helps Predict Success For Oral Appliance Therapy In Sleep Apnea
Treatment decisions or sleep apnea sufferers need no longer be quite so hit and miss as FDA clears Somnomed’s MATRx device for predicting outcome of Oral Appliance Therapy
Medtronic Settles Shareholder Class Action Over Infuse
Medtronic settles its shareholder class action lawsuit for $85M.
View From The Med Week 13. Is Our Approach To Testing Really That Casual?
View from the Med: Week 13 is a good read… as ever.
St Jude’s Brio™ Deep Brain Stimulation System Withdrawn For Fix
St Jude has recalled and suspended sales of its Brio Deep Brain Stimulation system until it resolves the issue of body fluid ingress, which it believes is causing a lack of therapeutic effect.
NICE Supports PleurX® In Treatment-Resistant Ascites Patients
NICE endorses vac-assisted PleurX drainage system for treatment-resistant ascites patients.
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.
FDA Clears Soma’s AxoTrack™ Needle Visualisation System
Soma’s Axotrack looks like a compelling, ultrasound-guided solution to the challenge of accurate needle placement. The company’s two newly FDA cleared applications suggest the agency agrees.
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.
Capsule Endoscopy Device Cleared For Crohn’s Diagnosis In Japan
Capsule Endoscopy marches forward with Given Imaging announcing the expansion of its indications in Japan to cover visualisation and diagnosis of Crohn’s disease.
Now LINX Reflux Management System Gains FDA Clearance
Torax’s LINX system of magnets acting to support the oesophageal sphincter gains FDA clearance.