Regulatory

Flexible Stent Solutions has been granted CE mark for an extended range of its Flexstent peripheral vascular stents. The new line, called Flextent Iliac, does pretty much what it says on the tin, extending the company’s offering to cover more vessels.

Intrinsic Medical Imaging says its newly FDA cleared, next generation 3D capabilities will provide visualisation and quantification tools designed to improve on existing conventional 2D and 3D methods.

According to a press release issued by US Law firm Bernstein Liebhard LLP, FDA has received almost 17,000 adverse event reports from 2000-2011, associated with metal hip implants, such as the DePuy ASR and Pinnacle hip systems. An FDA panel has been in session for two days to discuss the situation.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.

Terumo Cardiovascular Systems has issued guidance regarding what to do in the event of a false air bubble detector alarm, together with some corrections to the user manual, but is not recalling the devices, nor suggesting withdrawal from use.

One of the smaller devices featured on our pages, but nonetheless significant. Californian ophthalmic device company Glaukos has gained FDA approval for its iStent device, which relieves intraocular pressure in glaucoma patients.

Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. VivaSight™-DL comprises a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.

Smith & Nephew had already issued a Field Safety Notice on its R3 metal acetabular liner. Now MHRA has followed up with its issuance of a Medical Device Alert including direction on patient follow-up.

St.Jude must have issued a corporate sigh of relief when its investigators concluded that the recently reported incidence of Durata ICD lead failure was most likely caused by abrasion from another lead or indeed a calcified structure, rather than the inside-out abrasion which has characterised the company’s Riata family problems.

US Regulatory Agency, the FDA has selected Medtronic’s thoracic stent graft development product for inclusion in its early feasibility pilot program.

Eye health company Bausch + Lomb claims its newly FDA approved IOL is uniquely able to claim to be glistening free.

Back in February US congressional watchdog, the Government Accountability Office asked FDA to implement more stringent testing of medical devices before market release. Four months on a law firm sees fit to make a meal of it.

California’s InTouch Health has announced that it has received FDA 510(k) clearance with expanded indications for use for its Remote Presence devices. The range is now approved for active patient monitoring rather than a medical device data system, thereby exemplifying the FDA’s new approach to telemedicine device classification.

It’s industry body Eucomed’s job to be the cheerleader for Europe’s medical device industry members. And when Eucomed speaks, we listen. However, in what we’re hoping is a healthy contribution to the debate, we’re taking issue with some aspects of regulatory director John Brennan’s latest blog in which he is arch defender of the status quo.

Trireme hasn’t really explained why its PTA balloon catheter is called chocolate, but clinicians won’t care if FDA’s approval of further sizes means they can use it for more peripheral vascular indications.

Maquet is trumpeting its new generation of antibiotic/silver treated vascular grafts which it claims are effective against MRSA. The graft, branded Intergard Synergy, has gained CE mark status and is ready for launch.