FDA is actively encouraging organoids, organs-on-chips and computational models as alternatives to some animal studies, but reproducibility, validation and whole-body biology still prevent a simple one-for-one replacement.
West Cancer Center has received IRB approval to join IceCure’s 400-patient ChoICE post-market study of ProSense in women aged 70 and older with small, biologically low-risk breast cancers.
Most FDA-cleared surgical robots still operate under direct human control, while research systems are beginning to automate individual tasks. Moving from task automation to independent surgery requires solving perception, tissue variability, failure recovery and liability.
FIND Neuro’s CN-Suite analyzes intracranial EEG to rank seizure-driving brain regions, giving epilepsy teams quantitative decision support during presurgical evaluation for patients aged three and older.
FDA Fast Track gives Rein Therapeutics closer regulatory access as its 120-patient RENEW trial tests whether inhaled LTI-03 can translate promising biomarker effects into measurable preservation of lung function.
FDA is exploring competency assessment, risk-based monitoring and new lifecycle controls for generative AI medical devices whose outputs can vary by prompt, context and software evolution.
Orum plans an approximately 42-patient Phase 1 study of ORM-1153 after FDA cleared the CD123-targeting conjugate to deliver a GSPT1 protein degrader into AML cells.
Targeted protein degraders do not simply occupy a disease protein and block its activity. They recruit the cell’s disposal machinery to remove it, potentially opening targets conventional drugs cannot reach.
FDA-cleared OTC glucose sensors have opened continuous monitoring to people who do not use insulin, but evidence for weight loss and broad metabolic improvement in people without diabetes remains limited.
FDA cleared Cubresa BrainPET as a Class II PET-MR imaging system, allowing the removable brain-dedicated PET insert to be used with compatible Siemens infrastructure.