FDA Launches Technology-Enabled Meaningful Patient Outcomes

Technology-Enabled Meaningful Patient Outcomes by FDA will assess a risk-based enforcement approach to evaluate patient access to digital health devices.

FDA Clears Upgrade of Omnipod 5 Algorithm from Insulet

In order to offer much better insulin management, Omnipod 5 algorithm automated insulin delivery from Insulet has gone on to secure the FDA clearance.

GE HealthCare, Mayo Clinic Partner for Customized Radiation Therapy

In order to transition from a one-size-fits-all approach to customized radiation therapy, GE HealthCare and Mayo Clinic have expanded the partnership.

Lunit Aims FDA Nod for Breast Cancer Risk Prediction Model

Lunit is seeking clearance from FDA for its breast cancer risk prediction model - Lunit INSIGHT Risk which estimates 5-year risk of developing breast cancer.

Natera Adds ctDNA-Based MRD Tests with Acquisition of Foresight Diagnostics

Natera has added ctDNA-based MRD tests to its portfolio after acquiring Foresight Diagnostics, a company recognized for its expertise in MRD detection.

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