Siemens Healthineers has obtained FDA 510(k) clearance for the Mammomat B.brilliant mammography platform, featuring enhancements in user ergonomics and workflow, as well as reduced patient discomfort. Additionally, they have submitted a Premarket Approval application for the 3D tomosynthesis portion of the system.
A medical device manufacturer employee was sentenced to 1 year in prison for forging FDA clearance for 2 medical devices.
Perfuze announced FDA clearance for the Millipede 070 Aspiration Catheter and the second generation of the Millipede 088 Access Catheter.
Siemens Healthineers has obtained FDA 510(k) clearance for the Mammomat B.brilliant mammography platform, featuring enhancements in user ergonomics and workflow, as well as reduced patient discomfort. Additionally, they have submitted a Premarket Approval application for the 3D tomosynthesis portion of the system.
The FDA created a new medical device category covering UV devices to microbial reduction, requiring authorization before coming to market.
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The FDA granted clearance to HistoSonics Histotripsy therapy platform for non-invasive destruction of liver tumors using focused ultrasound.
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Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.
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The FDA cleared the CorVista System with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.
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Insight Medbotics has received U.S. FDA 510(k) clearance for its MRI-compatible IGAR robot for breast biopsy indications.
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Limaca Medical’s Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.
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The FDA has cleared Zeta Surgical's Zeta Cranial Navigation System mixed reality surgical navigation system.
