Breast AI Technology NABS FDA Approval
Medical artificial intelligence (AI) provider Lunit announces that the U.S. FDA has granted 510(k) clearance to its Lunit Insight MMG technology for breast cancer detection.
Category: Clearances
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Zimmer Biomet Nabs FDA Clearance for ROSA Hip System
Warsaw, Ind.-based Zimmer Biomet Holdings, Inc. announces that the U.S. FDA has granted 510(k) clearance to the ROSA Hip system for robotically assisted direct anterior total hip replacement.
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FDA Clears GE Healthcare AI MRI Technology
Waukesha, Wis.-based GE Healthcare announces that AIR Recon DL, a deep-learning image reconstruction technology that works across all anatomies, is now U.S. FDA 510(k) cleared on Signa 7.0T MRI scanners.
FDA Clears DePuy Synthes VELYS Robotic-Assisted Solution
DePuy Synthes has received 510(k) clearance from the FDA for the VELYS Robotic-Assisted Solution for use with the ATTUNE Total Knee System.
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FDA Clears Novaerus Defend 1050 to Inactivate Airborne Pathogens
Novaerus’ Defend 1050 uses patented NanoStrike technology to damage and inactivate airborne micro-organisms.
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FDA Clears BioSerenity EEG Wearable Device System
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.
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Micro-Tech Endoscopy and Interscope Announce Partnership, Extended FDA Clearance for EndoRotor System
Ann Arbor, Mich.-based Micro-Tech Endoscopy and Northbridge, Mass.-based Interscope Inc. have inked a deal to collaborate and distribute the EndoRotor System for interventional gastroenterology.
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Zebra Medical Vision Gets FDA Clearance for AI 3D Bone Modeling Solution
The recently patented medical imaging company’s AI solution extracts exact 3D bone reconstruction from X-ray scans at the same quality as a CT scan, enabling the use of standard X-rays for surgery planning.
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GE Healthcare Receives FDA Clearance for Vivid Ultra Edition CV Ultrasound
Vivid Ultra Edition cardiovascular ultrasound features leverage AI-driven, neural network-based algorithms to deliver repeatable and faster measurements in 2D echo imaging.
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Philips Launches Pre-Hospital Wireless Monitoring Technology
Royal Philips has launched a wireless remote monitoring and defibrillator solution (Tempus ALS) for pre-hospital settings in the United States.
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FDA Clears Servo-air Mechanical Ventilator
Wayne, N.J.-based Getinge announces that the U.S. FDA has cleared its Servo-air mechanical ventilator for use on adult and pediatric patients. The device is slated for availability in the U.S. in late 2020.
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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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FDA Clears Colibri Endoscopy System
Colibri Micro ENT Scope is the first single-use endoscope designed for otologists.
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FDA Clears Philips’ Ultrasound Portfolio to Combat COVID-19
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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FDA OKs Medtronic Pediatric Hemodialysis System
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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