Latest News for: ce marking

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FiberSense Continuous Glucose Monitoring (CGM) System obtains CE mark as commercial launch preparations begin

PR Newswire 17 Jun 2026
BASEL, Switzerland, June 17, 2026 /PRNewswire/ -- FiberSense AG ("FiberSense") today announced that the FiberSense Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017/745 as a Class IIb medical device.
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Penumbra Expands CAVT for Stroke to Europe with CE Mark for THUNDERBOLT

Missoulian 16 Jun 2026
The THUNDERBOLT TM Computer Assisted Vacuum Thrombectomy (CAVTTM) technology introduces modulated aspiration for acute ischemic stroke for the first time, enabling more rapid, complete clot removal ... .
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Cardiawave Announces First Routine Treatments Performed with Valvosoft� Following CE Mark Approval and Accelerates Its Deployment

Nasdaq Globe Newswire 15 Jun 2026
Cardiawave Announces First Routine Treatments Performed with Valvosoft� Following CE Mark Approval and Accelerates Its Deployment ... .
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Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee®

The Eagle-Tribune 12 Jun 2026
(Nasdaq.
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Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for ...

Nasdaq Globe Newswire 12 Jun 2026
BERKELEY, CA, June 12, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq ... .
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Sibel Health Receives EU MDR Class IIb CE Mark for ANNE® One: The First Wireless ...

The Columbus Telegram 11 Jun 2026
Class IIb certification and SDC interoperability bring traditional patient-monitor to a wireless, wearable form factor ... .
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Personalis (PSNL) Receives CE Mark Approval for Blood Collection Kits (Personalis Inc)

Public Technologies 11 Jun 2026
). The text version of this document is not available ... Disclaimer. Personalis Inc.
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DermaSensor Announces Class IIb CE Mark and Collaboration with NHS, Marking the Beginning of Its ...

Enid News & Eagle 10 Jun 2026
MIAMI--(BUSINESS WIRE)--Jun 10, 2026-- ... .
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Vara receives CE mark for tomosynthesis AI - extending Europe’s leading screening-grade AI portfolio to 3D

Nasdaq Globe Newswire 10 Jun 2026
Vara receives EU MDR CE mark for its tomosynthesis (3D mammography) AI, extending Europe's leading screening-grade AI portfolio to 3D imaging ... .
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Sibel Health Receives EU MDR Class IIb CE Mark for ANNE® One: The First Wireless Wearable Patient Monitoring Platform Certified to Key Interoperability Standards

PR Newswire 10 Jun 2026
CHICAGO, June 10, 2026 /PRNewswire/ -- Sibel Health Inc., an award-winning medical technology company, today announced that its ANNE® One system has received CE Mark certification under the European ...
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Medtronic Receives CE Mark for Stealth AXiS™ Surgical System for Ear, Nose, and Throat Procedures (Medtronic plc)

Public Technologies 08 Jun 2026
) June 8, 2026 - Medtronic, a global leader in healthcare technology, today announced it has received CE mark for the Stealth AXiS™ surgical system for ear, nose, ...
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Caretaker Medical Receives CE Mark for VitalStream® Multimodal Wireless Patient Monitoring Platform

Killeen Daily Herald 05 Jun 2026
Wireless VitalStream Platform Expands Across Europe for Invasive & Non-Invasive Continuous Hemodynamic Monitoring — ....
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Tandem Diabetes Care Automated Insulin Delivery Systems Receive CE Mark for Type 2 Diabetes and ...

Business Wire 05 Jun 2026
SAN DIEGO--(BUSINESS WIRE)---- $TNDM #TandemMobi--Tandem Diabetes Care receives CE mark for AID systems in Europe to include use in type 1 diabetes during pregnancy and adults with type 2 diabetes ... .
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Reach Surgical Receives CE Mark Approval for SOUND REACH™ Swift

PR Newswire 03 Jun 2026
Reach Surgical receives CE Mark approval for SOUND REACH™ Swift, plug-and-play ultrasonic shears designed for open surgery, including breast and thyroid procedures.
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UPMC Italy and United Imaging Healthcare bring Europe's first CE-marked uRT-linac 506c to Italy

PR Newswire 29 May 2026
The CE-Marked uRT-linac 506c system from United Imaging features a diagnostic-quality CT scanner integrated with the linear accelerator on a single platform, enabling a streamlined workflow from CT image guidance to treatment delivery.

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