Pulsar Vascular receives FDA IDE approval for the PulseRider® Aneurysm Neck reconstruction device for the treatment of intracranial bifurcation aneurysms
Regulatory
Steris Isomedix Still on FDA Naughty Step
If there was such a thing as a Naughty Step at FDA HQ, Steris Isomedix would probably be on it as it fails to close out numerous warnings to the agency’s satisfaction.
HeartWare Sanguine on FDA Warning Letter Resolution
HeartWare International tells us it will respond to the FDA over its warning letter, and has resolution of the matters raised well in hand.
Chocolate Catheter Gets Coronary Indication
TriReme’s Chocolate Catheter gets Coronary indication
Real-time Professional CGM a Reality as FDA Gives Nod to Dexcom G4 PLATINUM System
Continuous Glucose Monitoring (CGM) device company Dexcom, Inc., has received U.S. FDA approval for its Dexcom G4® PLATINUM Professional CGM.
CE Mark and EU Launch of Covidien’s Nellcor™ Respiration Rate Technology
Covidien plc, has announced the European commercial launch of its Nellcor™ Respiration Rate System
Hernia Mesh Fixation Glue Gains CE Mark
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.
FDA Clears EkoSonic® Endovascular System for Pulmonary Embolism
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.
U.S. Clearance for SafeWire’s Y-Wire® 2
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.
FDA Clearance for SpringTMS® Portable Migraine Treatment Device
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.
U.S. FDA Clears EkoSonic® Endovascular System for Treatment of Pulmonary Embolism
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).
FDA 510(k) Clearance for Single-Use Brella-Spec™ Vaginal Speculum
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.
Direct Flow Valve IDE Study to Start
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.
Could there be a First Bowel Anastomosis Sealant on Horizon?
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.
FDA Clears Accessory for Uterine Fibroid Treatment System
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.
FDA denovo Rules Pass Mind-Controlled Robotic Arm
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.