FDA Clears Empatica’s Remote Health Monitoring Platform
Empatica announced the clearance of its Empatica Health Monitoring Platform by the U.S. Food and Drug Administration (FDA).
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XACT Robotics System Nabs FDA Clearance
XACT Robotics, which offers a robotic system for interventional procedures, announces that the U.S. FDA has cleared its ACE Xtend Remote Control Unit, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from the control room.
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MedWand Solutions Makes Telemedicine Device & VirtualCare Platform Commercially Available
MedWand's telemedicine device and VirtualCare ecosystem are commercially available to better help enable clinical exams.
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FDA Clears Empatica’s Remote Health Monitoring Platform
Empatica announced the clearance of its Empatica Health Monitoring Platform by the U.S. Food and Drug Administration (FDA).
FDA Clears Siemens Healthineers’ Whole-Body MR Scanner
Siemens Healthineers announced U.S. FDA clearance of its whole-body MR scanner designed to help improve patient access to MRI.
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FDA Clears Xenco Medical’s New Spinal Surgical Device
Xenco Medical expands its ambulatory surgery center surgical device portfolio with the FDA clearance and launch of its Multilevel CerviKit.
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FDA OKs Embody Rotator Cuff Repair System
Medical device company Embody, Inc. announces that it has received U.S. FDA 510(k) clearance for its Tapestry RC system for rotator cuff repair.
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FDA Clears XACT Robotics Technology
XACT Robotics announces U.S. FDA clearance for a modification to its cleared XACT ACE Robotic System designed to support robotic insertion and steering of ablation probes during ablation clinical procedures.
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FDA Clears Linear Health Sciences’ Safety Release Valve
Linear Health Sciences received U.S. FDA clearance and Health Canada approval of its tension-activated breakaway safety release valve.
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New Collaboration to Develop 3D Printed Medical Devices for Cancer Care
Adaptiiv Medical Technologies is collaborating with HP and Varian to advance personalized cancer care with 3D printed medical devices.
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FDA OKs Biotronik Programmer for Implanted Cardiac Rhythm Management Devices
Lake Oswego, Ore.-based Biotronik, Inc. announces that it has received U.S. FDA approval of Renamic Neo, the company’s programmer for implanted cardiac rhythm management devices such as ICDs, pacemakers, and implantable cardiac monitors.
