Research Triangle Park, N.C.-based Asensus Surgical, Inc. announces that it has received U.S. FDA 510(k) clearance for 5 mm diameter articulating instruments, adding to the Senhance Surgical System technology platform.
Israel-based medical imaging technology company Nanox announces that it has been granted 510(k) clearance from the U.S. FDA for its single-source Nanox.ARC digital x-ray technology.
The Neuronaute EEG System and IceCap EEG wearable device will allow physicians to remotely monitor and assess electrical brain activity of people living with epilepsy.
Colibri Micro ENT Scope is the first single-use endoscope designed for otologists.
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Amsterdam-based Royal Philips announces that it has received 510(k) clearance from the U.S. FDA to market a wide range of its ultrasound technologies for the management of COVID-19-related lung and cardiac complications.
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The U.S. FDA has granted marketing authorization to Medtronic Inc. for the Carpediem System, which is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 5.5 to 22 pounds.
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Montvale, N.J.-based Pentax Medical has received FDA 510(k) clearance for the Imagina Endoscopy System, an endoscopy platform for gastrointestinal (GI) procedures. Specifically, Imagina offers practitioners a platform to visualize anatomy and improve the operator experience.
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The U.S. FDA has cleared the first fully disposable duodenoscope for marketing in the United States, the EXALT Model D Single-Use Duodenoscope from Marlboro, Mass.-based Boston Scientific Corp.
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Seattle-based Bardy Diagnostics, Inc. announces that it has received 510(k) clearance from the U.S. FDA for the 14-day version of the Carnation Ambulatory Monitor, a P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.
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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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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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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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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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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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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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