MassDevice3h
First patient enrolled in IDE study of Conformal Medical’s next-gen LAAO device
Conformal Medical today announced on social media that the first U.S. site enrolled a patient in a trial of its next-gen ...
Endovascular Today7h
Shape Memory Medical AAA-SHAPE Pivotal Trial Commences European Enrollment
Shape Memory Medical Inc. announced the first European patient enrollment in the AAA-SHAPE pivotal trial. The patient was ...
Hosted on MSN1mon
FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE ... The multi-centre, open-label RESORB trial will focus on providing a ‘sustainable’ and ...
Business Wire9d
Reprieve Cardiovascular Builds Clinical Momentum with Positive Results from FASTR Pilot Trial and FDA Investigational Device Exemption Approval for Pivotal Trial
The Company also announced they received Food and Drug Administration (FDA) approval to initiate an investigational device exemption (IDE) study, the FASTR II randomized pivotal trial, in the ...
The Victoria Advocate15d
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
MILAN, Feb. 5, 2025 /PRNewswire/ -- Newronika, the developer of groundbreaking adaptive deep brain stimulation technology, is proud to announce the receipt of an Investigational Device Exemption ...
Hosted on MSN2mon
Delcath to trial Hepzato drug device combo in colorectal cancer
Delcath System has received clearance from the US Food and Drug Administration (FDA) for an investigational new ... The open-label randomised study (NCT06607458) is expected to enrol 90 ...
Endovascular Today15d
CereVasc’s eShunt Evaluated in Pilot Study of Elderly Patients With NPH
CereVasc, Inc. announced the initial results of its United States pilot clinical study of the CereVasc eShunt system in the ...
PathMaker Neurosystems Announces IRB Approval for DoD-funded Clinical Trial of the MyoRegulator Device in ALS
Nader Yaghoubi, M.D., Ph.D., PathMaker’s Co-Founder and CEO, stated, “We are pleased to announce IRB approval for the CALM study, which allows us to commence enrollments shortly. Given the mechanisms ...