The Medical Futurist

JUNE 17, 2025

Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth. These provide real-time feedback via a companion app warning you if you are applying too much pressure, where you are brushing and even coach the user as to how to brush properly.

Patients 126

Patients Treatment Plan Healthcare Medical Specialty 126

FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. seeking treatment). This makes seeking clearance of an OTC home test a risky business endeavor.

Manufacturing 59

Manufacturing Clinic IT Transportation 59