FDA Clears Novaerus Defend 1050 to Inactivate Airborne Pathogens
Novaerus' Defend 1050 uses patented NanoStrike technology to damage and inactivate airborne micro-organisms.
Category: Clearances
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FDA Clears Boston Scientific Insertable Cardiac Monitor
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.
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VoCare Debuts Mobile Multi-Diagnostic Device
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.
Augmented Reality Surgical System Nabs FDA Clearance
The augmented reality surgical system, developed by New York-based Medivis, integrates augmented reality, artificial intelligence, and computer vision to advance surgical visualization.
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SafeOp Neuromonitoring System Nabs FDA Clearance
The 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.
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FDA, DoD Ink Deal to Advance Medical Products for Military Personnel
The 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.
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FDA Awards Grants to Advance Pediatric Medical Device Development
The 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.
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Avinger Notes Positive Outcomes with New Image-Guided Atherectomy System
Several vascular physicians report positive patient outcomes with company’s next-generation Pantheris system for the treatment of peripheral artery disease.
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FDA OKs EKF Diagnostics’ POC Hemoglobin Analyzer
UK-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.
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FDA OKs First Fully Interoperable Continuous Glucose Monitoring System
The 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.
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Innovation Ahead: Overcoming Obstacles to Medical Device Advancement
The 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.
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Tools of the Trade: SunTech Medical’s SunTech CT40
Morrisville, 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.
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FDA Clears Kent Imaging’s Perfusion Imaging Device
The 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.
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An Inside Look at Medical Imaging
From 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.
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FDA Clears First Duodenoscope with Disposable Distal Cap
The 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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