Posts Tagged ‘clearance’
LensAR Laser System(TM) Receives FDA Clearance For Use In Cataract Surgery
Tuesday, May 25th, 2010LensAR, Inc., the leading developer of next generation laser technology for cataract surgery and presbyopia, announced that the company has received 510(k) clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery.
The LensAR Laser System integrates propriety ocular measurement and 3D laser scanning technologies with an advanced tissue cutting laser. The clinical data from the APEC Hospital Mexico City showed the laser capsulotomies were significantly more precise than manual capsulorhexis in the intended vs. achieved diameter and in circularity.
“The capsulotomy is arguably the most critical and precise step in cataract surgery and the ability to improve its sizing, centration, and consistency through automation is an important and exciting advance,” stated Dr. David F. Chang, LensAR Medical Monitor, who has personally used the LensAR Laser System in Mexico.
Dr. Louis D. “Skip” Nichamin, Medical Advisory Board member, who also has had experience using the system directly, commented, “The application of femtosecond technology to cataract surgery is the most exciting development in ophthalmic surgery in decades. The increased precision of the LensAR technology can help in the improvement of surgical outcomes while assisting experienced and inexperienced surgeons achieve more consistent results.”
“This is a critical milestone for the company. Our first cleared indication of what we believe will be many to come in this exciting new field of laser cataract surgery,” said Randy Frey, founder and chief executive officer of LensAR.
About LensAR, Inc.
LensAR, Inc. is the leading developer of next generation laser technology for cataract surgery and presbyopia. The LensAR Laser System, which integrates an advanced ultra short pulse laser with propriety ocular measurement and laser scanning technologies, is being designed to allow physicians to perform several of the steps in cataract surgery (capsulotomy, lens fragmentation, precise astigmatic corrections and unique clear corneal incisions) in a single laser procedure. In addition to advancing its laser technology in the area of cataract surgery, the company is also developing the LensAR Laser System for the treatment of presbyopia.
The LensAR Laser System is cleared by the FDA for anterior capsulotomy. For other indications it is an investigational device limited by United States law to investigational use only.
Optovue Announces FDA 510(k) Clearance For IVue SD-OCT
Monday, May 24th, 2010Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced that the new iVue compact SD-OCT has received FDA 510(k) clearance on April 29, 2010.
“The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have seen very high demand – as expected – in the first quarter,” stated Paul Kealey, Vice President of Marketing for Optovue. “This regulatory clearance for the US market allows us to offer the benefits of advanced OCT imaging to more segments within eye care, where the economic feasibility of the larger systems simply did not work. The iVue begins the next phase of the OCT revolution in the US that started with the RTVue launch in 2006.”
The iVue compact SD-OCT system is delivered on a standard slit lamp style base and is comprised of a small scanning head (4.5 lbs / 2.2 kg), a control module, laptop PC and foot switch. The system can be mounted to a small table and may have other mounting options in the near future for other eye care environments.
About RTVue and iVue
RTVue was the first FDA cleared Fourier domain (also known as spectral domain) OCT launched in the United States, and also the first OCT cleared by the U.S. Food and Drug Administration for both corneal and retinal imaging. The iVue is the compact fourier-domain version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician.
About Optovue
Optovue Incorporated is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, CA, with operations in Carlsbad, CA and European operations in Heidelberg, Germany.
Boston Scientific Announces FDA Approval for LATITUDE® Patient Management System Software Upgrade
Wednesday, May 12th, 2010Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval for LATITUDE 6.0, a software upgrade to the Company’s LATITUDE® Patient Management system. The LATITUDE system enables physicians to remotely monitor patients with implantable cardiac devices. The upgrade provides enhanced functionality, including the ability to view an expanded history of a patient’s remote follow-up data.
The LATITUDE Patient Management system can detect changes in a patient’s heart health status between scheduled follow-up visits and send relevant data and alerts directly to physicians. More than 160,000 patients have been enrolled on the system at more than 2,300 clinics across the U.S. The LATITUDE system is available in 15 other countries and use of the system continues to expand internationally with nearly 1,700 patients enrolled in Europe at approximately 150 clinics.
In 2009, the LATITUDE system detected more than 7,000 patients with at least one event of atrial arrhythmia. Patients with atrial arrhythmias such as atrial fibrillation, particularly those with heart failure, are at increased risk of stroke. By identifying atrial arrhythmias earlier, physicians have the opportunity to intervene with treatments that may reduce patient risks.
“Remote monitoring between regularly scheduled follow-up visits allows earlier observation of events, giving physicians the option to intervene earlier,” said Kenneth Stein, M.D., Chief Medical Officer, CRM, for Boston Scientific’s Cardiology, Rhythm and Vascular Group. ”We welcome FDA approval of LATITUDE 6.0, which offers software improvements in response to physician feedback.”
The LATITUDE Patient Management system will be demonstrated at Boston Scientific’s booth (#1017) during the 31st Annual Scientific Sessions of the Heart Rhythm Society, May 13 – 15 in Denver.
SOURCE Boston Scientific Corporation
Covidien Receives FDA 510(k) Clearance For Puritan Bennett 840 Ventilator To Extend Minimum Delivered Tidal Volume, Enabling Care Of Neonatal Patients
Monday, May 10th, 2010Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Puritan Bennett™ 840 ventilator’s minimum delivered tidal volume down to 2 mL. This feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams.
The Puritan Bennett 840 ventilator delivers a comprehensive, user-friendly solution offering ventilation for a broad range of patients and acuity levels, from neonates to adults. Multiple therapies of ventilation help clinicians respond with the most appropriate ventilation strategy, including a neonatal continuous positive airway pressure (CPAP) mode, enabling noninvasive ventilation in neonates.
The ability to deliver a minimum tidal volume of 2mL will enable clinicians to safely ventilate the smallest and most critically ill neonatal patients with the Puritan Bennett 840 ventilator. This feature will complement recent enhancements to the Puritan Bennett™ 840 NeoMode™ software, including neonatal CPAP mode and the ability to increase the fraction of inspired oxygen (FiO2) by 20% for up to two minutes during suctioning. An increased FiO2 is necessary to manage adequate oxygenation in patients who are critically ill.
“This FDA 510(k) clearance allows Covidien to make clinicians aware that one device, the Puritan Bennett 840 ventilator, can be used on all patients from newborn to adults,” said Douglas Hansell, M.D., M.P.H., Chief Medical Officer and Vice President, Respiratory and Monitoring Solutions, Covidien. “Now patients, from the smallest neonates in the NICU through adults in the ICU, can receive the clinical benefits provided by the Puritan Bennett 840 ventilator.”
Diazyme Receives FDA 510(k) Clearance To Market SMART HbA1c Assay On Its SMART Point Of Care System For Diabetes Monitoring
Monday, May 10th, 2010Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its SMART HbA1c Assay on its new SMART Point of Care System for diabetes monitoring. The SMART HbA1c Assay offers rapid testing capabilities and is based on Diazyme’s proprietary Direct Enzymatic HbA1c assay technology.
The assay can be run from a simple finger stick blood sample obtained in a physician’s office and delivers accurate and reliable results in minutes. Unlike other point of care systems for HbA1c, the Diazyme SMART HbA1c Assay has been shown to have no interference from common hemoglobin variants including Hb E, Hb C, Hb S and Hb D traits. This means the assay offers freedom from interference in HbA1c testing, which is of special importance today as the HbA1c test is now considered the key test for diagnosis and screening of diabetic disease.
“Diazyme’s new SMART HbA1c Assay provides a convenient and cost effective test method which will benefit laboratories, physicians and the patients they care for,” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. In addition to HbA1c, the SMART Point of Care System offers the capability to run tests for monitoring renal function as well as cardiac risk assessment. Additional assays in development for the SMART Point of Care System include Cystatin C, which has been shown to be a more reliable marker than creatinine for early detection of acute and chronic kidney disease, and Enzymatic Homocysteine and high sensitivity hsCRP, both of which are important biomarkers for cardiac and stroke risk assessment.