Spectral AI announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its DeepView System, authorizing the company to commence commercial distribution activities in the United States.
California-based Subtle Medical has announced FDA clearance for SubtleHD(PET), its next-generation PET image enhancement solution designed to improve image quality and accelerate PET imaging workflows across PET/CT and PET/MR systems.
Chicago, Illinois-based Cardiosense announced that the US Food and Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software, which is designed to estimate noninvasively pulmonary capillary wedge pressure (PCWP), a key indicator of heart health.
A new map of the human eye made using donated eyeballs that could help explain and possibly prevent a handful of sight-related diseases.
DNA can be exchanged between two cells that connect by forming nanotubes, and find out why this is crucial for cancer research.
The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.
Abbott (NYSE:ABT) announced today that it received CE mark approval for its dual glucose-ketone sensing technology for people with diabetes.
Engineers at the University of California San Diego have created a soft, wearable ultrasound patch that can continuously monitor a fetus for hours at a time—and it can do so consistently even as the fetus and umbilical cord constantly move during pregnancy.
Researchers at Umeå University have conducted a unique three-dimensional mapping of an entire human pancreas. The study shows that insulin-producing cells can remain long after the onset of type 1 diabetes—a finding that suggests the disease progression is more complex than previously assumed.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Alzheimer’s Test, a urine-based diagnostic test developed by TOBY, a biotechnology company based in Austin, Texas.