Company

Product

Description

Indication

Status

Brainbox Solutions Inc., of Richmond, Va.

Brainbox TBI

A multi-modality, quantitative test that combines injury-related blood protein biomarkers with computerized neurological assessments

To aid in both the diagnosis and prognosis of mild traumatic brain injury (TBI)

U.S. FDA granted breakthrough device designation

Dt Medtech LLC, of Baltimore

Hintermann series H3 total ankle replacement system

Three-piece, mobile-bearing implant

For use as a noncemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease

Received premarket approval from the U.S. FDA

Guided Therapeutics Inc., of Peachtree Corners, Ga.

Luviva Advanced Cervical Scan

Noninvasive device based on biophotonic technology

Detect cervical disease at the point of care

China‘s National Medical Products Administration requested a small clinical trial of 60 to 120 patients to be completed with 3 months; following the trial, Shandong Yaohuo Medical Device Technology Co. Ltd., the company's partner and distributor for China, will file final paperwork for approval

Heartflow Inc., of Redwood City, Calif.

Heartflow FFRct Analysis

Noninvasive cardiac test; creates a personalized 3D model of the heart based on artificial intelligence-based analysis of fractional flow reserve (FFR)

Better evaluate the impact a blockage has on blood flow to determine the best treatment for patients with coronary heart disease

NHS England has extended Heartflow's participation in the Innovation and Technology Payment program for an additional year; NHS England will provide reimbursement to NHS hospitals for the usage of the Heartflow FFRct Analysis until March 31, 2020

Ryah Medtech Inc., of New York

Commercial grade dry-herb cartridges

Cartridge used with company‘s dose-measuring vaporizer and associated real-time, AI powered data aggregator

Tracks data regarding medical plant strain effects on patients; measures the amount of vapor a patient inhales

Received a Medical Device Establishment License from Health Canada

U Deliver Medical LLC, of Hopkins, Minn.

Bfed system

Tube feeding delivery system

Nutrition delivery for home tube feeders

Received U.S. FDA 510(k) regulatory clearance for the Bfed system to be available to consumers without a prescription

Notes

For more information about individual companies and/or products, see Cortellis.

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