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TEM-News
TEM-Events
Tempus AI Receives FDA Clearance for ECG-PH Software
Tempus AI announced it has received 510(k) clearance from the U.S. Food and Drug Administration, FDA, for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead electrocardiograms, ECGs, for signs associated with pulmonary hypertension. "Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive," said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. "This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the spectrum of cardiovascular disease. We're building tools that can help clinicians surface risk earlier."
Tempus AI Stock Rises 10.2% to $67.51
Tempus AI is up 10.2%, or $6.26 to $67.51.
Tempus AI Stock Rises 9.5% to $67.04
Tempus AI is up 9.5%, or $5.79 to $67.04.
Tempus AI Stock Rises 20.1% to $59.30
Tempus AI is up 20.1%, or $9.94 to $59.30.
Tempus AI Announces Strategic Collaboration with CellCarta
Tempus AI announced a strategic collaboration with CellCarta, a global CRO laboratory supporting the biopharmaceutical industry. Under the agreement, CellCarta will include Tempus in its CDx Commercialization Lab Network as the network's second commercial laboratory partner, strengthening oncology-focused companion diagnostics offerings to biopharma sponsors. CellCarta is a global CRO laboratory to the biopharmaceutical and biotechnology industries, partnering with translational medicine, biomarker, and clinical development teams to generate reliable, regulator-ready data. Within the CellCarta network, the collaboration gives biopharma sponsors a more direct route from companion diagnostic development and regulatory approval to commercial use in U.S. oncology practice. CellCarta develops and validates the CDx, generates the analytical and clinical evidence package, supports regulatory submissions, and performs centralized immunohistochemistry and tissue-based testing. Tempus will support provider test ordering through Tempus Hub, routing sample testing to CellCarta and transmitting results back to ordering healthcare providers.
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