Regulatory

Maxx Medical has announced that its “Freedom Knee” has recently received Chinese SFDA approval and will shortly be available throughout the country. Freedom Knee is a complete, high-flexion primary knee replacement system specifically engineered to address the need for smaller sized and differently proportioned implants that better support Asian lifestyle and physiology.

Maquet is recalling certain of its Flow-i Anesthesia Systems due to a software problem which requires a fix. FDA considers the recall Class I which implies use of the product may cause serious adverse health consequences or death.

r4 Vascular, Inc. has announced FDA clearance to market its Vector™ Percutaneous Transluminal Angioplasty balloon catheters in 28 sizes. All Vector™ balloon catheter sizes are rated for up to 30 atmospheres of pressure and are radiopaque when deflated or inflated.

Stryker has undertaken a voluntarily global recall for its Rejuvenate and ABG II modular-neck stems because of post-marketing surveillance data which suggests a potential risk of what it has termed “fretting and corrosion”.

Consumers Union is a powerful patient rights advocacy group in USA, and as such it’s perhaps not surprising to see it welcoming the Unique Device Identifier proposals from FDA… and asking why it’s taken so long.

FDA has cleared ProPep’s Nerve Monitoring System, the first real-time nerve monitoring system specifically designed for use during robotic surgery.

UK competent authority the MHRA has issued a Medical Device Alert pertaining to Baxter’s Flogard and Colleague infusion pumps, one lot of which may have been incorrectly assembled.

Ethicon has issued a dire warning about inappropriate use of its Evicel® spray applicator, which raises the question of how well important information like this gets distributed outside US.

CareFusion has issued an update following its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall, which means the problem constitutes a reasonable probability of serious adverse health consequences or death.

Abbott has announced that it has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs) with the FDA approval of Healon EndoCoat OVD, a device intended for use as a surgical aid in cataract extraction and intraocular lens (IOL) implantation.

Minimally invasive lumbar spine device company TranS1 Inc., has announced it has received CE mark approval in the European Union to market its VEO™ lateral access fusion system for interbody fusions.

Israeli company Brainsway Ltd. has received CE Mark for its Deep TMS system to treat neuropathic chronic pain (“neuropathic pain”). This indication adds to the treatments already CE marked, which include clinical depression among others.

W. L. Gore & Associates, Inc. has received CE mark for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the Gore® Excluder® AAA Endoprosthesis for treatment of abdominal aortic aneurysms(AAA). The company says its new diameter devices provide physicians with the ability to repair AAAs in a wider range of anatomies eligible for minimally invasive endovascular AAA repair.

Teleflex Incorporated has announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter has received FDA 510(k) clearance for central venous pressure monitoring indication.

Synergetics USA, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT™, a novel vitrectomy system for the retinal surgery market.

UK competent authority the MHRA has issued an alert following the death of a patient from Hepatitis, thought to have been transmitted via an inadequately processed reusable probe.