FDA 510(k)
The Brazilian company, which is a partner of GE HealthCare, received clearance for its nCommand Lite solution that provides remote operation support for imaging centers.
Also, AIM will be collaborating with Stanford Medicine to validate its diagnostic endoscopic AI.
The wearable device directly measures respiration to predict deterioration in COPD patients.
The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials.
The Cardiac Scale monitors patients with fluid management conditions like heart failure and kidney disease.
Eko Murmur Analysis Software is a machine learning algorithm that detects and characterizes heart murmurs in adult and pediatric patients.
The cuffless device uses a sensor array over the radial artery to produce a pressure waveform that's used to determine systolic and diastolic blood pressure.
It has been approved as a prescription-only software-as-a-medical device in the US.
The StrivePD app uses Apple's Movement Disorder API to track tremors and uncontrolled body movement.
EarliPoint Evaluation monitors a child's looking behavior while watching videos to help a clinician identify autism spectrum disorder.