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CE Mark

Medical Devices & Diagnostics

Medtronic expands Affera platform with Sphere-360 catheter CE Mark and IDE trial kickoff

Medtronic’s Sphere-360 catheter earns CE Mark and begins U.S. IDE trial. Find out what this means for the future of pulsed field ablation.

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Medical Devices & Diagnostics

May Health’s Anavi System CE Mark highlights a new middle ground in PCOS infertility treatment

May Health’s Anavi System wins CE Mark. Find out what this means for PCOS infertility care, clinical adoption, and regulatory pathways in Europe.

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Medical Devices & Diagnostics

What Nitinotes’ EASE trial tells us about the future of bariatric endoscopy

Nitinotes Ltd. has begun patient enrollment in its pivotal U.S. Investigational Device Exemption study evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The first procedure in the EASE Clinical Trial was completed at Lenox Hill Hospital | Northwell Health in New York, marking the U.S. debut of the device. This study pits

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