The Landscape of Medical Device Development in the NIDA Small Business Program | National Institute on Drug Abuse (NIDA)

See caption and tables below — The active NIDA Small Business Medical Device Development Program categorizes medical devices by their development stages, as detailed in NIH Reporter project descriptions. These stages include preclinical development, clinical feasibility, clinical pivotal studies, FDA clearance/approval, post-approval studies/labeling expansion. Overall, medical devices are divided in two major categories and their expected indications, namely: monitoring/diagnostics devices (with indications of overdose detection, SUD monitoring, OUD Risk Prediction, In-Vitro Drug Detection, Drug Detection wearables) and therapeutic devices (classified as digital therapeutics for SUD, OUD neuromodulation, opioid-sparing pain treatments, NOWS, smoking cessation). This depiction is not exhaustive.

OTIPI SBIR/STTR Therapeutic Devices

SUD Digital Therapeutics

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
NXTECH DA058531 INNATEVR DA059475	BIOM DEV CORP DA059017 RELATEVR DA055405 NEUROTYPE DA057773	BEHAVR DA053848 BIOM DEV CORP DA054881

OUD Neuromodulation

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
		MINDLIGHT DA050358 HIGHLAND DA049685		SPARK DA053876

Opioid-sparing Pain

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
MMJ LABS DA058952 H-CUBED DA056250	OPALGENIX DA056280 TAMADE DA049630	ALTALITY DA050365 PASCALL DA053075	APPLIEDVR DA050231

NOWS

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
		SPARK BIOMEDICAL DA050360 PRAPELA DA049300

Smoking Cessation

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
PREDICTABLY HUMAN DA060773 HAVA HEALTH DA057798 CRA RIVER AN DA059018

OTIPI SBIR/STTR Monitoring-Diagnostic Devices

Overdose Detection

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
RTM VITAL SIGNS DA059491 RESCUE BIOMEDICAL DA056277 AUTONOMOUS HEALTHCARE DA058470	ALTRUMED LLC DA 056276 NEUROPTICS DA055407	AYUDA MEDICAL DA051257

SUD

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
NEUROTYPE DA059517	CONTINUEYOU DA056162 HIGHLAND INSTRUMENTS DA058979 WAVI COMPANY DA058431 EVON MEDICS DA056156 OPIAID DA058474	REKOVAR DA049615 SQUARE2 SYSTEMS DA047150 CONTINUOUS PRECISION MEDICINE DA055408

OUD Risk Prediction

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
OPALGENIX DA058430 OPALGENIX DA053877

Drug Detection - In-Vitro

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
	INSTANOSIS DA055415 INSTANOSIS DA060264 ARBORSENSE DA052941			INSTANOSIS DA060647

Drug Detection - Wearable

Preclinical	Clinical Feasibility	Clinical Pivotal	FDA cleared	Post-approval Label expansion
ACTIOX LLC DA059516	VOX BIOMEDICAL LLC DA049655 CARI HEALTH DA059523 EMITECH DA051289

July 30, 2024