EDN

Virtual prototype broadens IDE concept

The concept of the integrated development environment is gaining wide attention in the system-on-chip industry. When most people speak of an IDE, they are focused only on software, and indeed the ...
PR Newswire

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

TAMPA, Fla., April 2, 2024 /PRNewswire/ -- Concept Medical has been granted 'IDE Approval' from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) ...
Business Insider

Concept Medical Inc. Raises $60mn for Investigational Device Exemption (IDE) for the World's First Sirolimus-Coated Balloon

SURAT, India, Oct. 9, 2018 /PRNewswire/ -- Concept Medical Inc. Raises $60mn For Investigational Device Exemption (IDE) For The World's First Sirolimus-Coated Balloon. Concept Medical Inc. (CMI) has ...
MarketWatch

Concept Medical Announces First Patient Enrollment in the MAGICAL BTK IDE Trial, Launching its PAD Clinical Program in the United States

TAMPA, Fla., Jan. 16, 2025 /CNW/ -- Concept Medical Inc., a global pioneer in innovative drug delivery technology, is proud to announce the successful enrolment of the first patient in the "MAGICAL ...
Benzinga.com

Concept Medical's fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease (SFA)

TAMPA, Fla., May 29, 2023 /CNW/ -- The US FDA, on the 24 th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch ...
PR Newswire

CONCEPT MEDICAL ANNOUNCES ENROLLMENT OF FIRST PATIENT IN "MAGICAL-ISR" IDE STUDY IN THE US

The MAGICAL-ISR study aims to assess the safety and efficacy of this Sirolimus DCB in treating ISR, focusing on the proportion of patients avoiding Target Lesion Failure (TLF) within one-year ...