Saturday, June 7, 2025

DeepTek’s Chest X-ray AI Achieves EU MDR Certification


DeepTek’s breakthrough Chest X-ray AI now globally licensed, boosting diagnostic pace, accuracy, and entry to essential healthcare!

Highlights:

  • DeepTek’s Chest X-ray AI resolution is now an authorized Class IIb medical gadget underneath EU MDR
  • The AI can detect over 20 lung issues and acknowledge medical gadgets in chest X-rays, together with pediatric instances
  • With CE-marking and US FDA CADe certification, DeepTek can develop its options globally, serving to areas with excessive TB burden and radiologist shortages

DeepTek experiences that its Chest X-ray AI resolution has been licensed as a Class IIb medical gadget underneath the European Union Medical Machine Regulation (EU MDR) (1 Trusted Supply
DeepTek’s Chest X-ray AI resolution receives CE MDR Class IIb certification

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).

Chest X-ray AI Resolution Helps Establish 20+ Lung Problems

The aim of the Chest X-ray AI resolution is to assist docs analyze frontal chest X-rays (AP/PA views). With the assistance of subtle machine studying, the answer can establish greater than 20 completely different lung issues, together with rib and clavicular fractures, in addition to nodules, lung plenty, TB, and pneumothorax.

Moreover, the answer acknowledges a lot of medical gadgets which can be ceaselessly seen in intensive care items and inpatient settings, together with pacemakers, chest leads, and completely different tubes, which provide essential help in difficult scientific conditions.

This strategy may also learn pediatric chest X-rays and detect pediatric tuberculosis and pneumonia, therefore enhancing diagnostic capacities in youthful populations, that are ceaselessly underserved by conventional AI fashions.

DeepTek Acquires CE-Mark and Full US FDA CADe Certification

DeepTek can now make its resolution out there throughout Europe and different CE-mark-recognized places, offering a powerful instrument to spice up productiveness, lower diagnostic delays, and promote high quality care supply on a big scale.

Moreover, it has acquired full US FDA CADe certification, demonstrating its dependability and scientific rigour in medical imaging purposes.

The necessity for such options is particularly pressing in areas with a excessive tuberculosis burden and restricted entry to specialist radiologists. With a rising tuberculosis burden and an growing radiology workload, CE certification paves the trail for implementation in Europe, Asia, Africa, and different CE-marked places the place AI-driven diagnostics will not be solely useful however essential.

The know-how has been deployed at 325 TB screening websites, supporting nationwide TB applications and public well being actions throughout a number of geographies.

Reference:

  1. DeepTek’s Chest X-ray AI resolution receives CE MDR Class IIb certification – (https://www.expresshealthcare.in/information/deepteks-chest-x-ray-ai-solution-receives-ce-mdr-class-iib-certification/448793/)

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