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MEDICAL DEVICES, TECHNOLOGIES, EQUIPMENT, SUPPLIES

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification. Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm.

LuViva Advanced Cervical Span Awarded New CE Mark with Expanded Claims

The new CE Mark includes expanded claims for the use of LuViva by physicians for the early detection of cervical cancer.

Kardium Receives CE Mark for Globe® Mapping and Ablation System

The Globe® Mapping and Ablation System can now be used by electrophysiologists across Europe to safely and effectively treat patients with AF.

Ambu and Medical Advisory Fuel Medical Group Announce Partnership

“This is a perfect match that will enable both companies to expand their reach into new and growing markets,” said Juan Jose Gonzalez, CEO of Ambu A/S.

Gynesonics Reports Sonata System Assists Facilities Impacted by the COVID-19 Pandemic in Restarting Elective Gynecologic Procedures

Sonata integrates the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device to treat symptomatic fibroids in a transcervical, incision-free, uterus-preserving manner.

Medtronic Evolut TAVI System Receives Expanded Indication in Europe to Treat Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

The Evolut TAVI System, with its excellent hemodynamics, allows for improved heart function that helps many patients resume their pre-aortic stenosis activity.

Masimo Sleep™, a New Wellness Solution That Allows Users to Better Understand Their Sleep Quality

Masimo Sleep analyzes your data to provide truly personalized multi-dimensional insight into your sleep health, empowering you with actionable guidance to help you make healthier lifestyle choices that improve your sleep.

Medtronic and Foxconn Partner to Increase Ventilator Production

Medtronic and Foxconn are currently ramping up plans to produce 10,000 PB560 ventilators over the next year at Foxconn’s Wisconsin Valley Science and Technology Park in Mount Pleasant, Wis. The ventilators will be marketed and sold by Medtronic.

icotec ag Receives Approvals for Two KONG® VBR Spinal Systems Made with BlackArmor® and Ti-iT® in Europe and the US

"This is exciting news for icotec ag and our team as it allows us to expand our portfolio in multiple countries simultaneously, to include implants made from radiolucent, nonmetallic BlackArmor® material with a 360° osseoconductive Ti-iT® pure titanium coating," said Roger Stadler, CEO of icotec ag.