MassDevice

Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes

Aqua Medical has received investigational device exemption (IDE) from the FDA for its ablation device aimed at treating ...
JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
MassDevice

FDA expands indications for Wandercraft robotic exoskeleton

Wandercraft announced today that the FDA expanded the indications for its flagship Atalante X rehabilitation device.
KJZZ

FDA approves device to help patients with severe calcium buildup in heart valve

The FDA has approved the Tendyne device to replace the mitral heart valve through a small incision between the ribs. Dr. Paul ...
STAT

Uniqure’s FDA submission for its Huntington’s disease therapy thrown into question

In a major setback, Uniqure said that the timing of when it can file its Huntington's treatment for FDA approval "is now ...
Le Lézard

Incyte Announces More than 50 Abstracts Accepted for Presentation at the 2025 ASH Annual Meeting

Incyte today announced that data from key programs in its oncology portfolio will be presented in both oral and poster sessions at the 2025 American Society of Hematology (ASH) Annual Meeting, to be ...

FDA says clinical data for UniQure's Huntington's disease therapy not adequate

UniQure , said on Monday its experimental gene therapy for Huntington's disease does not have adequate clinical data to ...