FDA Approves a Pediatric Valve That Can Expand With Growth—With Durability Still to Be Earned.
The FDA’s October 1 approval of Edwards Lifesciences’ AUTUS Size-Adjustable Valve is a real pediatric-device inflection point, not simply a…
NeuroAI Needs an Error Budget, Not a Vibe Check
NeuroAI is often framed as whether a system can “understand” a person. That framing is too loose for a product…
Octant Takes an Oral Rhodopsin Corrector Into Patients—But the Human Evidence Clock Has Just Started.
Octant has reached a meaningful but early clinical threshold in inherited retinal disease. The company announced first-patient dosing in the…
NeuroAI Should Not Be a Label: It Should Change a Real Human-AI Outcome
NeuroAI is often discussed as though a neural signal automatically makes an AI system more insightful. It does not. A…
ELPIS II’s Primary Endpoint Miss Is the Headline. The Harder Question Is What Its Exploratory Signals Can, and Cannot, Tell Families Facing HLHS.
Longeveron’s September 16 readout from ELPIS II provides a demanding but important lesson in clinical-trial interpretation. The Phase 2b study…
SKY-0515’s Fifteen-Month Huntington’s Dataset Has a Stronger Signal Than Typical Early Readouts. Its External-Control Design Still Sets the Standard for Caution.
Skyhawk Therapeutics’ September 15 release on SKY-0515 offers an unusually detailed early clinical picture for Huntington’s disease. The company reported…
NeuroAI Must Earn Its Place in the Physical AI Stack
Neural and physiological measurements may be useful research inputs. They are not a shortcut around behavioral evidence, artifact control, or…
XRPL BatchV1_1 Is Supported but Still Disabled. That Is Exactly Why Integrators Must Separate Readiness From Activation
Amgen announced on September 14 that the FDA approved an update to the prescribing information for IMDELLTRA, or tarlatamab-dlle, that…
NeuroAI Meets Physical AI: Why the Human Side of Robotics May Become Its Next Data Layer
BrainLayer is applying a NeuroAI-enabled Human Model to Physical AI, with an evidence-first approach to human-state data, robotics recovery, and…
Nanobiotix Reports Complete Phase 1 JNJ-1900 Data in Recurrent NSCLC. The Signal Is Interesting, but the Re-Irradiation Setting Demands Careful Reading.
Nanobiotix has reported complete-cohort results from a Phase 1 study of radiotherapy-activated JNJ-1900, also called NBTXR3, in patients with inoperable,…
FDA Expands Sevabertinib’s Accelerated Approval in HER2-Mutant NSCLC. The Response Data Are Encouraging, but Confirmation Still Matters
The FDA has expanded the accelerated approval of sevabertinib, marketed as Hyrnuo, for adults with locally advanced or metastatic non-squamous…