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Results For "FDA-clearance"

62 News Found

Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA
People | May 01, 2026

Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA

Tamir brings more than 20 years of experience in the medical technology sector


Philips wins FDA nod for AI-powered spectral CT system Verida
Medical Device | April 20, 2026

Philips wins FDA nod for AI-powered spectral CT system Verida

At the core of Verida is Spectral Precise Image technology paired with a third-generation Nano-panel Precise dual-layer detector and an AI-based deep learning reconstruction engine


Zeto gains FDA nod for new outpatient EEG system promising faster brain health testing
News | April 10, 2026

Zeto gains FDA nod for new outpatient EEG system promising faster brain health testing

The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE


Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy
Biotech | March 31, 2026

Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy

The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors


Siemens Healthineers expands radiotherapy beyond cancer, targets osteoarthritis pain
News | March 25, 2026

Siemens Healthineers expands radiotherapy beyond cancer, targets osteoarthritis pain

The radiotherapy systems include TrueBeam, TrueBeam STx, VitalBeam, and Edge


Bayer expands MRXperion power injector capabilities with FDA nod
News | March 06, 2026

Bayer expands MRXperion power injector capabilities with FDA nod

The system also introduces Imaging Scanner Interface 2 (ISI2) capability, enabling direct communication between injector and scanner to improve exam coordination and operational efficiency


LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system
News | February 18, 2026

LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system

The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes


Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening
News | February 07, 2026

Hologic’s Aptima HPV test bags FDA nod for primary cervical cancer screening

Hologic has been at the forefront of cervical cancer screening for decades