Acclarent’s voluntary recall of its Inspira Air™ balloon dilatation system has been formalised as a FDA Class 1 recall.
Regulatory
Landmark FDA Clearance For GINTUIT™ Oral Soft Tissue Regeneration Sheet
FDA Approval for Organogenesis Inc’s Gintuit™ marks first cell-based product for use in dental market.
Do New EU Rules On Electronic Instructions For Use Go Far Enough?
Bravo European Commission for allowing electronic Instructions For Use, but we think you could have gone a bit further.
Medical Device Alert: LeMaitre’s AlboGraft “Uncontrolled Bleeding” Cases
What’s the appropriate course of action when a sealed vascular graft is found on several occasions to suffer uncontrolled bleeding and the manufacturer doesn’t know the cause?
Human Face Of Riata Lead Problem
St Jude’s Riata problems have been covered by Minneapolis’ Star Tribune with a report on the recent summit and the tale of a re-do patient.
View from the Med Week 10 Now Available. Enjoy the Read
Regulatory approvals, mergers and acquisitions, meetings and congresses… and even a bit of telehealth. Quelle Surprise!
FDA Clearance For Covidien’s Everflex™ Long Peripheral Stent
Covidien’s past acquisitions keep coming up trumps. EV3’s Everflex™ device has now been cleared for US marketing by FDA, bringing a useful new long stent option to peripheral vascular surgeons.
Baxano’s iO-Flex® Spinal Decompression System Gains CE Mark
Baxano’s iO-Flex® Spinal Decompression System is heading to Europe with CE mark approval following its earlier FDA clearance.
Abbott’s Absolute Pro® Vascular Stent Receives FDA Approval For Iliac Artery Disease
Abbott’s Absolute Pro Stent for Iliac Disease has gained FDA clearance. The product is designed for precise stent placement and Optimal Flexibility to Conform to Challenging Lesions.
CE mark For Medtronic’s Next Generation MRI-Friendly Pacing Lead
Medtronic raises the bar in MRI compatible pacing leads with CE mark for its new small diameter offering.
FDA Issues Guidance On TriVascular Ovation EndoGraft For Patients With Small Access Vessels And Small Aortic Anatomy
After granting approval for TriVascular to sell its Ovation Endograft in USA under Humanitarian Exemption, FDA now issues guidance for consumers.
All-Metal Hips: Media Coverage Won’t Necessarily Aid Regulatory Reform
Did you hear the one about the company that thought it had a winner on its hands by developing its own version of an increasingly popular type of hip replacement?
K2M’s SANTORINI™ Corpectomy Cage Systems Gain FDA Clearance
K2M Inc has announced the FDA 510(k) clearance of its Santorini Corpectomy Cage System, adding to the company’s portfolio of offerings for treatment of complex spine disorders.
CE Mark For Checkpoint® Neuroprotective Stimulator Device
Checkpoint’s newly CE marked device helps surgeons avoid nerve damage.
FDA Clears Covidien’s Solitaire™ FR Revascularisation Device
With a certain inevitability following rave reviews in its pivotal clinical study, Covidien’s revascularisation device for removing clots from occluded vessels in stroke patients has now gained FDA 510(k) clearance.
UK MHRA Responds To Media Criticism
MHRA fights back against media claims that it needs to “recover its grip” over medical device regulation in light of the metal-on-metal hip situation.