The U.S. FDA says that it has granted 510(k) premarket clearance to what it deems the “first new major technological improvement for CT imaging in nearly a decade”—Siemens Healthineers’ Naeotom Alpha CT scanner.
Penumbra announces U.S. FDA 510(k) clearance and commercial availability of the Red 62 Reperfusion Catheter, the latest addition to the company’s comprehensive Penumbra System.
NeuroCap is a disposable pre-gelled EEG headset with 22 electrodes and 19 active EEG channels located in accordance with the 10-20 system.
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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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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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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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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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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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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