Products

TriReme’s Chocolate Catheter gets Coronary indication

Continuous Glucose Monitoring (CGM) device company Dexcom, Inc., has received U.S. FDA approval for its Dexcom G4® PLATINUM Professional CGM.

Covidien plc, has announced the European commercial launch of its Nellcor™ Respiration Rate System

A cyanoacrylate adhesive device designed for hernia mesh fixation under a Development and Pre-Supply Agreement between Surgical Innovations And AMS, has received CE approval.

EKOS Corporation has gained U.S. FDA clearance to market its EkoSonic® Endovascular System for the ultrasound-facilitated, controlled and selective infusion of physician-specified fluids, for the treatment of pulmonary embolism.

Device maker SafeWire has received U.S. clearance to market its split-tip orthopedic guidewire, designed to prevent inadvertent advancement of the wire through bone.

With its new FDA clearance, SpringTMS becomes the first medical device available to patients in the United States to relieve the pain caused by migraine headaches that are preceded by an aura.

EKOS Corporation has gained U.S. FDA clearance to market its EkoSonic® Endovascular System for the ultrasound-facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE).

Proa® Medical, Inc., developer of innovative and practical medical devices for women’s health, says it has received U.S. FDA 510(k) clearance to market its single-use device, the Brella-Spec™ Vaginal Speculum.

We’ve followed Direct Flow Medical’s twin-inflatable ring TAVI offering as it gained CE mark approval in Europe. Now it’s reached the next phase in the U.S as it gains FDA’s nod to commence the pivotal phase of its IDE trial.

Ethicon Endo-Surgery has launched its HARMONIC ACE®+7 Shears with Advanced Hemostasis, the first purely ultrasonic device with a 7 mm sealing indication. It claims the system outperforms its rival LigaSure™device when it comes to burst pressure.

Surgical adhesive specialist Cohera Medical, Inc.®, has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures. The company says approval is expected by the end of 2014.

Uterine Fibroid specialist company, Halt Medical has announced that the U.S. FDA has granted 510(k) clearance for the Acessa Guidance Hand Piece, an accessory for the treatment of symptomatic uterine fibroids.

The U.S. FDA has cleared for marketing the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.

The U.S. FDA has deemed as a Class 1 recall the Datascope Corporation/MAQUET voluntary worldwide field correction, issued in March of certain of the company’s Intra-Aortic Balloon Pumps (IABPs). A potential mechanical failure means the system could shut down, with adverse patient consequences.

Biotronik says the U.S. FDA has approved its Entovis pacemaker system with ProMRI® technology. The Entovis system allows patients to undergo MRI scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.