ImmersiveTouch’s COO, Jay Banerjee says, “adding this additional FDA 510(k) Clearance for medical diagnosis and treatment planning to our portfolio just strengthens what ImmersiveTouch can offer surgeons.”
"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Peter Marks, M.D., Ph.D.,
"We are excited to receive FDA clearance for the ISR indication, which expands our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated treatment options," commented Jeff Soinski, Avinger's President and CEO.
Brainance MD™ is currently in use in Europe as a CE Marked device where numerous clinical organizations have integrated it in their daily clinical brain MRI processing workflows. With this first FDA clearance the company aims to collaborate with U.S. clinicians by assisting them to focus on clinical findings and save valuable time.
The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.
PillCam SB3 @HOME provides a telehealth option for direct visualization and monitoring of the small bowel, to help better detect lesions not detected by upper and lower endoscopy that may: 1) indicate Crohn's disease, 2) locate obscure bleeding, or 3) identify sources of iron deficiency anemia (IDA).