Since 1976, the U.S. Food and Drug Administration (FDA) has allowed manufacturers to apply for an accelerated pathway to bringing their devices to the market. It's called the 501(k) Premarket Notification. In short, if a new device gets proved safe and effective to a device that's already available, the new device can get cleared because it's considered substantially similar to the older one. The FDA also allows for the first-cleared device (also known as the predicate) to be another product
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Biotech Startup ParaGen Technologies Raises $3M to Redefine Tissue Engineering
ParaGen Technologies, a Columbus, OH-based holding company of four tissue engineering medical device companies, announced that it raised $3 million in funding. The round was managed and organized through Ikove Venture Partners’ global network of investors (70% of the funds came from investors across 10 countries).Tissue EngineeringThe field of tissue engineering is focused on developing solutions to recreate the biological structures of the body. Generally, the synthetic products currently
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AliveCor Receives “Breakthrough Device” Designation from FDA for Bloodless Hyperkalemia Test
AliveCor, a Mountain View, CA-based digital health startup developing solutions to transform cardiac care, announced on Monday received “breakthrough device” designation from the U.S. Food and Drug Administration for their bloodless hyperkalemia test. Developed with Mayo Clinic, AliveCor’s KardiaK Platform screens for elevated levels of blood potassium – hyperkalemia, without requiring any blood from the patient.This designation signals that the FDA will consider the technology on an
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Sen. Alexander: Patients Need a “Breakthrough” on Medical Devices
U.S. Senator Lamar Alexander (R-Tenn.) today said that America’s patients need a “breakthrough” in the medical device industry after touring Smith & Nephew, a medical device company in Memphis, Tennessee.
“We hear a lot about the negative effects of the medical device tax, but what I’m hearing more from the medical device community is about the negative effects of regulatory burdens on doctors and patients,” said Alexander, chairman of the Senate health committee. “We’ve had a
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How Sensors Are Transforming the Life Sciences Industry Landscape
An in-depth look into how sensors are having a major impact on innovation and the competitive landscape for the life sciences industry (medical devices, diagnostics and pharma).
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