FDA Approval

Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.

Minnesota based Nonin Medical, Inc., has announced FDA 510(k) clearance and commercial release with expanded labelling claims for its Onyx® Vantage 9590 professional fingertip pulse oximeter.

This clever device from ApniCure Inc., gets around the need for a mask in treating sleep apnea, by employing a soft mouthpiece which together with a vacuum created by the device pulls the palate forward and stabilises the tongue. FDA agrees and has cleared the device under its 510(k) regulations.

Covalon’s IV Clear™ Silicone dressing is comfortable to wear and remove and contains two antimicrobial components within its adhesive layer, making it a compelling proposition in the market for securement of such as IV access devices. Now the product has FDA clearance to add to its Health Canada approval.

MAQUET Cardiovascular LLC has announced that it has received FDA 510(k) clearance for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater haemodynamic support, regardless of their height.

Following CE marking earlier this year, Heart Rhythm 2012 sees Sorin announce FDA approval and US launch of its new pacing, defibrillation and left ventricular leads.

Biotronik ticks another big box with the FDA clearance of its Lumax 740 ICDs and CRT-Ds equipped with home monitoring, supporting the company’s claim to have the only CE and FDA approved remote cardiac patient management system for early detection of clinically relevant events.

Filtration device specialist Nephros, Inc., has announced FDA 510(k) clearance to market its Hemodiafiltration (“HDF”) system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate.

FDA has cleared Angiodslide’s tiny Proteus™ device for balloon angioplasty and embolic capture in peripheral vessels. It works by folding in on itself on deflation, in so doing drawing the embolic fragments into a sort of inverted balloon-bag. Clever.

Laparoscopic surgery instruments may need to be larger than the access portal through which they are delivered, which means some degree of internal assembly could open up possibilities for more useful devices. Now the way is clear as FDA issues its first such clearance.

FDA has cleared Theragenics subsidiary Galt’s Valved Tearaway Introducer, opening the door for the company to gain access to a $14m market.

Femtosecond laser technology is fairly new to the ophthalmic surgical profession, especially in the US. Now FDA has cleared Abbott’s device for the creation of curved incisions in corneal surgery including cataract access.

Sotera Wireless Inc is on a mission to improve vital signs monitoring in ambulatory patients. FDA clearance of the company’s ViSi Mobile™ System has just been announced.

Custom Spine’s foray into MIS spinal surgery is kicked off this week with the news that its newly FDA cleared Securis cannulated pedicle screw system is on show at AANS Miami.

Medtronic declares itself pleased, but in reality must be absolutely delighted by the news that FDA has allowed it to expand the indications for its CRT-D resynchronisation/defibrillator devices to now include patients with mildly symptomatic heart failure.

Useful little device, fiXate™ from Anulex Technologies Inc., has now had its indications extended by FDA, allowing for its use in securing intrathecal pain pump catheters.