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The noninvasive, remote electrical neuromodulator was first cleared by the FDA in May 2019 for the acute treatment of migraines in patients 18 years and older. Read More
Notifiable actions include risk communications, recalls, label changes, reassessments, suspensions or revocations of authorization to prevent serious risk of injury to human health, the agency said. Read More
MEBsleep uses AI, deep-learning algorithms and neural-network methodology to assess large amounts of raw patient data to help physicians evaluate a patient’s condition. Read More
Preventice’s BodyGuardian monitors utilize a cloud-based platform and an independent diagnostic testing facility that uses clinical technicians and artificial intelligence algorithms to inform clinical diagnoses for cardiac arrhythmia. Read More
The system does not require pre-operative imaging to accurately resect bones and position knee implants, and offers advanced planning capabilities, the company said. Read More
The company is currently seeking Emergency Use Authorization from the FDA and approval from Japan’s Pharmaceuticals and Medical Devices Agency for the test. Read More