Eko wins FDA nod for AI to detect sign of heart failure using stethoscope
April 4, 2024
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
The CEO of Prenosis told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.
The low-cost hardware outperforms state-of-the-art versions and could someday enable an affordable, in-home device for health monitoring.
TEG testing provides critical information that can help physicians improve hemostasis management for their patients
HeadaTerm 2 uses neuromodulation technology. It releases targeted electrical impulses that increase the pain tolerance of the wearer.
The Venus Versa Pro combines the applicator of the Venus Viva MD with the Venus Versa system which are both approved in Australia and registered in Australian Register of Therapeutic Goods (ARTG).
This milestone gives healthcare professionals an important tool for managing bacteremia by providing antibiotic susceptibility test (AST) results with unprecedented speed.
“This really is a landmark moment and we’ll be working with the NHS and others to ensure a fair rollout that reaches people as quickly as possible.”
Benefits of the system, according to a news release, include maneuverability and visualization.
The clearance ends a three-year back-and-forth with the FDA to get the product to market.