An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval ...
Kennewick, WA, July 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide TherapyTM (PRnT) solutions, today announced the submission of its Investigational Device ...
InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, announced that the FDA has approv ...
MIAMI, Oct. 07, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the U.S. Food ...
Please provide your email address to receive an email when new articles are posted on . OnPoint’s AccuraSee magnifier has been granted investigational device exemption approval by the FDA. The device ...
Dymicron’s Triadyme-C artificial disc earned the FDA’s investigational device exemption approval, according to a July 10 news release. The IDE approval opens the door for a U.S. trial of the disc, ...
Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA
Kennewick, WA, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (RDGL) Following the 30-day review period, the FDA declined approval of the Radiogel ® IDE submission. We are now focused on addressing the ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results