STAT5d
FDA OKs novel device for non-invasive treatment of spinal cord injuries
The FDA Thursday approved the ARC-EX System designed to restore mobility after spinal cord injury by delivering programmed ...
Health Affairs12d
FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not ...
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
Medical Design and Outsourcing8d
First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Flow Medical is developing a thrombolysis catheter that delivers TPA through hollow nitinol tubes to treat pulmonary embolism ...
Hosted on MSN19d
FDA partners with Children’s National Hospital for paediatric device innovation
To address challenges associated with testing novel medical devices for children and perinatal care, the five-year research partnership will involve sharing de-identified clinical data and using ...
Medical Design and Outsourcing18d
FDA and Children’s National partner on pediatric device innovation
Children's National Hospital and the FDA announced a collaboration to develop regulatory science tools (RSTs) for pediatric ...
EurekAlert!21d
Children’s National, FDA collaborate to advance pediatric device regulatory tools
This partnership aims to address long-standing challenges in testing novel medical devices for children and for perinatal care. By sharing de-identified clinical data and leveraging advanced ...
Pharmabiz20d
UK MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach
These novel medical devices have the potential to significantly improve the diagnosis and care of patients. Those selected for the pilot include medical devices for cancer and chronic respiratory ...
News Medical29d
Emory University Hospital performs first U.S. implant of novel ventricular assist device
An expert team led by veteran cardiothoracic surgeon Mani Daneshmand, MD, successfully implanted a novel magnetically ... with the device, joined by other leading medical institutions across ...
MassDevice4d
FDA approves Merit Medical’s cell-impermeable endoprosthesis
With approval, the company can begin commercializing the device in the U.S. in 2025.