Sterling Medical Devices participated in the development of two blood test systems.
Microcard-Based Blood Test Systems: The test is performed with a reader that processes 384-well microplates. Each well contains reagents to analyze the blood and a reading is recorded for each well. The readings are analyzed to give the overall test results. A very important part of the system is the ability to present the large amount data in a manner that allows for the operator to make a diagnostic decision.
Platelet Aggregation Detection System: This can help diagnose disorders such as lupus. The system consists of a disposable test kit and a point-of-care base unit. The point-of-care base unit is a device that detects and reports platelet aggregation in whole blood using laser light scattering.
The systems interact with hospital systems to transfer test results and allows for operator configurable reports to be generated.
On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and...
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.
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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