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FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition

SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of ...
STAT

The last ‘breakthrough’ devices to get special treatment from Medicare

Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer ...
STAT

Beyond detection: In the age of clinical AI, what counts as an FDA ‘breakthrough’ medical device?

Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer ...
Yahoo Finance

Airiver Medical Granted FDA's Breakthrough Device Designation for Pulmonary Drug Coated Balloon to Treat Central Airway Stenosis; First Patient Treated in Clinical Trial

BROOKLYN PARK, Minn., March 4, 2026 /PRNewswire/ -- Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, was granted ...
Morningstar%2c Inc.

Xenco Medical Unveils XenVision, an AI-Driven Musculoskeletal Health Breakthrough at SIGGRAPH 2026, the World’s Premier Computer Graphics Conference

On July 19th, pioneering medical technology company Xenco Medical unveiled its breakthrough XenVision technology, an AI-powered musculoskeletal intelligence platform that combines advanced computer ...