Apple Watch sleep apnea detection gets FDA clearance
Samsung’s Galaxy Watch also got FDA authorization for its sleep apnea feature earlier this year. Apple will also roll out ...
Apple Watch's Sleep Apnea Detection Feature Receives FDA Clearance
The U.S. Food and Drug Administration today published clearance of sleep apnea detection on newer Apple Watch models, as ...
Elon Musk goes all Star Trek as his sight-giving Blindsight brain implant gets FDA 'breakthrough' clearance
Elon Musk's Blindsight brain implant has achieved a major milestone. It's now being worn by Geordi La Forge. No wait, it's ...
Neuralink's 'breakthrough device' clearance from FDA does not mean it has cured blindness
Neuralink, the Elon Musk-owned brain-computer interface company, has received "breakthrough device" clearance from the FDA.
CD (Suzhou) Biopharma Announces FDA Clearance for Phase I Clinical Trial of CD-001
Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of CD-001, entering a Phase I first-in-human trial.
GE Healthcare wins FDA clearance for Alzheimer’s imaging software
The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to help clinicians determine the density of amyloid ...
Targeted Oncology1d
FDA Clears Investigational New Drug Application for CD-001 in Oncology
Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.
MassDevice2d
Alesi Surgical wins FDA clearance for smoke management device and lands new funding
Alesi Surgical designed the Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing ...
FierceBiotech3d
GE HealthCare claims FDA clearance for amyloid imaging software in Alzheimer’s disease
GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density ...