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Tongue Implant System

Sterling Medical Devices participated in the development of a Tongue Implant System. The system was composed of microprocessing devices, including a controller and an external mouthpiece, which act...
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Resources

Robot hand holding medical icons

April 17, 2023

New FDA Guidelines for Artificial Intelligence and Machine Learning in Medicine and Medical Devices

Are you developing cutting-edge technology using artificial intelligence (AI) or machine learning (ML) in medicine? Are the vague regulatory requirements for AI and machine learning in medicine...
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5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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