New Screening Panel Helps ID Risk Factors
Polymer Technology Systems, Inc. (Indianapolis, Ind.) announced the availability of a new test strip to test important risk factors for cardiovascular disease (CVD) and diabetes. The new test strip provides readings for total cholesterol, high-density lipoprotein cholesterol, and glucose with just one drop of blood. No fasting is required, and the test is Clinical Laboratory Improvement Amendments waived and FDA approved for all ages. The test is performed on a CardioChek PA analyzer.
The new screening panel is an improvement that helps practitioners quickly identify patients who may be at risk for CVD or diabetes in a convenient 2-minute test.
Noninvasive Total Hemoglobin Test Cleared
Masimo (Irvine, Calif.) has received FDA approval of its noninvasive and continuous total hemoglobin monitoring technology, SpHb. The new product should make hemoglobin measurement more convenient and broadly available to clinicians in hospital and outpatient settings, allowing earlier clinical decisions, improved patient safety, and decreased costs. Noninvasive hemoglobin testing will be offered as part of the upgradable Masimo Rainbow Signal Extraction Technology (SET) platform.
The company notes that noninvasive hemoglobin monitoring with Masimo Rainbow SET SpHb may enable more restrictive transfusion triggers, help maintain optimal hemoglobin levels for critically ill patients, and should work to allow better management of chronic anemia.
FDA Approves New Heart Devices
Boston Scientific (Natick, Mass.) received FDA approval of its COGNIS cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN implantable cardioverter defibrillator (ICD). These devices represent new platforms to treat heart failure and sudden cardiac death, and feature significant engineering advances that eliminate tradeoffs among device size, battery longevity, and features often made when prescribing high-energy devices, according to the company.
COGNIS CRT-D and TELIGEN ICD are among the smallest and thinnest high-energy devices. Both devices offer features based on substantial engineering advances, including extended battery longevity over previous company devices, self-correcting software, and improved programming technology.
These products are designed to be used with the LATITUDE Patient Management System.
New Dermatologic Laser System Approved
The FDA approved Lutronic's (Princeton Junction, N.J.) Spectra VRM III, a dual-pulse Q-Switched Nd:Yag laser that is the feature-rich successor to the Spectra VRM II. The laser produces four wavelengths in Q-switched nanosecond pulse and is specifically designed to treat a wide array of dermatologic and aesthetic conditions, including dermal and epidermal pigmented lesions, multicolor tattoos, melasma, and active acne. The new laser further enables laser toning, and non-ablative photoacoustic skin rejuvenation techniques.
The laser uses a dual pulse mode and has extreme high peak power and a flat-top beam profile. It is effective for the treatment of melasma and postinflammatory hyperpigmentation that may result as adverse side effects from other lasers. It also enables removal of a wide range of tattoo colors.