investigational device exemption

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Fonte della foto: Adnkronos
... MedAlliance is pleased to make the following announcement: SELUTION SLR™, MedAlliance's novel sirolimus - eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to ...
Adnkronos  -  25-10-2022
Fonte della foto: Adnkronos
... SIRONA First - in - Human and SIRONA 2 , as well as the currently enrolling global investigational device exemption (IDE) trial, PROACTIVE - HF . Designed to unlock the power of comprehensive HF ...
Adnkronos  -  29-9-2022
Fonte della foto: StraNotizie.it
Dopo anni di ricerche, lo studio IDE ( Investigational device exemption ) approvato dalla FDA nel 2021, con la partecipazione di 250 pazienti in tutto il mondo affetti da patologie della cartilagine ...
StraNotizie.it  -  23-9-2022
Organizzazioni:fdaide
Prodotti:calciocarbonio
Luoghi:italiapavia
Fonte della foto: Padova News
TAMPA, Fla., Sept. 17, 2022 /PRNewswire/  The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In - Stent Restenosis (ISR).
Padova News  -  18-9-2022
Fonte della foto: Adnkronos
This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval. "We are very excited ...
Adnkronos  -  24-8-2022
Fonte della foto: Adnkronos
GENEVA, Aug. 10, 2022 /PRNewswire/ - - SELUTION SLR™, MedAlliance's novel sirolimus - eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months ...
Adnkronos  -  10-8-2022
Fonte della foto: Adnkronos
...prove that SELUTION SLR is more effective than the current standard of care in this difficult patient population." The start of enrollment in the study follows IDE (Investigational Device Exemption) ...
Adnkronos  -  8-6-2022
Fonte della foto: Adnkronos
The device has shown early promising clinical results in treatment of patients with chronic limb threatening ischemia (CLTI) and below - the - knee artery disease. In the PRESTIGE study which was ...
Adnkronos  -  30-5-2022
Organizzazioni:fdaus
Luoghi:stati unitiue
Tags:debdrug
Fonte della foto: Adnkronos
Investigational Device Exemption (IDE) study that achieved its primary endpoint and over five years showed a significant reduction in recurrent ischemic stroke across all PFO anatomies compared to ...
Adnkronos  -  20-1-2022
Fonte della foto: Adnkronos
BOSTON, Jan. 12, 2022 /PRNewswire/ - - Biotechnology company Evolved by Nature announced today that sister company Silk Medical Aesthetics has received Investigational Device Exemption (IDE) approval from the FDA to initiate a pivotal clinical trial for its new dermal filler for the correction of moderate to severe facial wrinkles and folds, such as ...
Adnkronos  -  12-1-2022
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