Submissions and Approvals

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May 11, 2021
Orthofix Medical’s Pediatric Orthopedic Procedure Planner Gets 510(k) Clearance
The system allows surgeons to accurately visualize the JuniOrtho implant in relation to the patient’s anatomy, assisting in selecting the correct size of device and optimally positioning it prior to surgery.
May 11, 2021
FDA Clears Conformis’ Knee Replacement System
The system uses a 3D best-fit algorithm to choose implants that are best for patients based on computed tomography scans.
May 11, 2021
Olympus Receives FDA Clearance for Airway Mobilescopes
The mobilescopes display shareable high-resolution images of the airway on an LCD monitor and can record still images and videos.

May 10, 2021
Medo Gets FDA Clearance for AI-Powered Thyroid Ultrasound Tool
May 10, 2021
Perosphere Technologies Obtains CE Mark for Blood Coagulation Meter
May 7, 2021
Balloon-Expanding Covered Stent Earns CE Mark
May 7, 2021
AlgoDx’s Intensive Care Sepsis Algorithm Receives European OK
May 7, 2021
MY01 Earns FDA Clearance for Continuous Compartment Pressure Monitor

May 7, 2021
Genesis 3D Shoulder Arthroplasty Planner Cleared
May 6, 2021
FDA Clears Life Spine’s Lateral Spacer System
May 6, 2021
Bio-Rad Laboratories Earns CE Mark for RT-PCR COVID-19 Test Kit
May 6, 2021
Siemens Healthineers’ COVID-19 Antigen Test Cleared in Europe for At-Home Testing
May 5, 2021
FDA Clears Motus GI’s Pure-Vu System for Upper Gastrointestinal Endoscopy