Tag-Archive for ◊ FDA clearance ◊

• Tuesday, January 21st, 2014

St. Jude Medical quietly accepts FDA premarket approval for its Cool Flex ablation catheter and ablation generator for treatment of arrhythmia. Medtech titan St. Jude Medical (NYSE:STJ) won FDA premarket approval for its Cool Flex cardiac ablation system with indication to treat irregular heart rhythms. St. Jude accepted the win quietly, with not announcements listed on its site […]

• Thursday, December 05th, 2013

FDA Clears TYRX Antibacterial Envelope for Use with Spinal Cord Neuromodulators MONMOUTH JUNCTION, N.J.–(BUSINESS WIRE)–TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance for expanded indications in marketing the AIGISRx N Antibacterial Envelope for use with spinal cord neuromodulators. This comes after the recent FDA clearance of the AIGISRx […]

• Monday, November 18th, 2013

The Food and Drug Administration on Thursday approved an implantable brain-stimulating device for patients with hard-to-treat epilepsy. The agency said it cleared Neuropace’s RNS Stimulator to reduce seizures in epilepsy patients who have not responded well to medications. The device is implanted in the skull beneath the scalp and attaches to one or two wires […]

• Saturday, November 16th, 2013

Lumenis Receives US FDA and Japanese MHLW Clearance for Array(TM) LaserLink(TM) Pattern Scanning Device for Multi-Spot Retinal Laser Treatment SAN JOSE, CA–(Marketwired – Nov 15, 2013) – Lumenis Ltd., the world’s largest medical laser company for ophthalmic, surgical and aesthetic applications, today announced that the company has received US FDA and Japanese MHLW clearance for […]

• Wednesday, October 23rd, 2013

Cardiovascular Systems, Inc. Receives Coronary FDA Approval ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (CSII), today announced that it has received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries. “Today is a landmark moment […]

• Wednesday, October 23rd, 2013

Having received European clearance last May, Medtronic is now announcing that its Advance Aspiration catheter won FDA approval in the United States. The device is designed to remove thrombi from coronary arteries during angiographic procedures. The device features variable braiding technology that allows for different levels of flexibility along the length of the catheter.  The inner metal […]

• Monday, October 14th, 2013

SAN DIEGO, Oct. 10, 2013 /PRNewswire/ — Sotera Wireless, Inc. today announced the U.S. Food and Drug Administration has cleared the Company’s patented continuous non-invasive blood pressure (cNIBP) technology, a new feature of the ViSi Mobile wireless patient monitoring system. For the first time clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the use […]

• Monday, October 07th, 2013

PHILADELPHIA, Oct. 3, 2013 /PRNewswire/ — Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company developing its Symphony CGM System as a non-invasive, wireless, continuous glucose monitoring system, today announced a corporate update covering Company activities, expected near-term achievements and comments on recent events. Corporate Objectives The Company’s corporate objectives for the remainder of 2013 are as follows: […]

• Monday, October 07th, 2013

Montreal-area based Maetta Sciences Inc. has obtained FDA clearance on its cobalt chrome orthopedic implantable device manufactured with the firm’s proprietary metal injection molding (MIM) technology. This project was developed in close collaboration with one of the company’s large OEM customer. The company plans to rapidly start the production of this device for market introduction this […]

• Thursday, September 12th, 2013

Parascript Granted FDA Approval for Mammography Computer-Aided Detection System Longmont, Colorado (PRWEB) September 04, 2013 — Parascript, LLC, the image analysis and pattern recognition technology provider, today announced FDA premarket approval (PMA) of its AccuDetect 6.1 Computer-Aided Detection (CAD) system for digital mammography. AccuDetect is indicated for use in screening mammography to identify areas suspicious […]