FDA Clears Novaerus Defend 1050 to Inactivate Airborne Pathogens
Novaerus' Defend 1050 uses patented NanoStrike technology to damage and inactivate airborne micro-organisms.
Novaerus' Defend 1050 uses patented NanoStrike technology to damage and inactivate airborne micro-organisms.
Boston Scientific has received 510(k) clearance from the U.S. FDA for the LUX-Dx Insertable Cardiac Monitor System, a device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope.
Indiana-based VoCare, Inc. has developed a professional-grade medical diagnostic device that collects six different health vitals and is equipped with WiFi, Bluetooth, and 4G LTE for data transmission, without the need for separate peripherals or an external hub.
The augmented reality surgical system, developed by New York-based Medivis, integrates augmented reality, artificial intelligence, and computer vision to advance surgical visualization.
Read MoreThe U.S. FDA has granted 510(k) clearance to Carlsbad, Calif.-based Alphatec for its SafeOp neuromonitoring system for use in spine surgery procedures. Based on the Alpha Informatix platform, the automated system is designed for intraoperative nerve location and health assessment in real time.
Read MoreThe U.S. FDA and the Department of Defense’s Office of Health Affairs have signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.
Read MoreThe U.S. FDA announced that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia across the country that will provide advice and support services to innovators of children’s medical devices. The program aims to enhance the development, production, and distribution of pediatric medical devices and has awarded $37 million to various consortia since 2009.
Read MoreSeveral vascular physicians report positive patient outcomes with company’s next-generation Pantheris system for the treatment of peripheral artery disease.
Read MoreUK-based in vitro diagnostics company EKF Diagnostics announces that the U.S. FDA has granted it 510(k) clearance for its hand-held, reagent-free hemoglobin analyzer, the DiaSpect Tm. The device is cleared for use in point of care and Certificate of Waiver settings, such as physicians’ offices, clinics, and other non-traditional laboratory locations.
Read MoreThe U.S. FDA has permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in those ages 2 and older. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible, FDA officials say.
Read MoreThe entrepreneurial pathway for innovation is rarely a straight line, nor does it often return quick results, maintains Watershed Idea Foundry CEO Nick Cordaro. In this article, Cordaro explains how companies can overcome impediments to medical device advancement.
Read MoreMorrisville, N.C.-based SunTech Medical, which manufacturers the CT40 spot-check device for blood pressure monitoring, announces that it received third-party validation for blood pressure performance as specified by the British Hypertension Society and AAMI/the International Organization for Standardization.
Read MoreThe U.S. FDA has cleared KD203, a portable multispectral medical imaging device developed by Calgary, Alberta, Canada-based Kent Imaging. KD203 provides insight into the availability of oxygenated blood in tissue, thus streamlining diagnosis, treatment planning, and patient monitoring.
Read MoreFrom November 26 through December 1, imaging professionals from around the world will convene in Chicago for the Radiological Society of North America’s annual meeting. Ahead of the show, here are some technologies generating buzz in radiology.
Read MoreThe U.S. FDA has cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope, manufactured by Pentax of America, is intended to provide visualization and access to the upper GI tract.
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