Karim Aly

Breath-based Analysis: Revolutionizing Disease Screening for a Healthier Tomorrow

By Karim Aly
Karim Aly

Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization.

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Thomas Ring

Designing Compliant Wireless Medical Devices

By Thomas Ring
Thomas Ring

Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.

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Randy Horton

FDA-Cleared SaMD by the Numbers

By Randy Horton
Randy Horton

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.

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