Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

Feb 13, 2023

Tampa (Florida) [US], February 13 (ANI/PRNewswire): Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA,...

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

Jan 11, 2023

Geneva [Switzerland], January 11 (ANI/PRNewswire): SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal...

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

May 01, 2023

Tampa (Florida) [US], May 1 (ANI/PRNewswire): The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus...

MedAlliance SELUTION SLR receives second FDA IDE approval

Aug 10, 2022

Geneva [Switzerland], August 10 (ANI/PRNewswire): SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal...

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

May 29, 2023

Tampa (Florida) [US], May 29: The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical...

First US patient enrolled in SELUTION SLR IDE Peripheral Study

Aug 24, 2022

Geneva [Switzerland], August 24 (ANI/PRNewswire): The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance's novel...