FDA
1 min.Read

Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators

The App is Designed to Facilitate Patient Compliance and Improve Outcomes Now Captures Patient Reported Outcome Measures

Orthofix Medical Inc. a medical device company focused on musculoskeletal products and therapies, today announced the U.S. Food and Drug Administration (FDA) approval of the STIM onTrack™ mobile app version 2.1 for use with the Company’s bone growth stimulators.

The STIM onTrack technology works with the Orthofix Bone Growth Therapy devices. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes. The new version of the app hosts Patient Reported Outcome Measure (PROM) questionnaires which enable patients to remotely share the status of their quality of life and functional well-being with their physician. This is in addition to the daily treatment reminders and device usage calendar that allows physicians to remotely view patient data to monitor treatment.

“The new STIM onTrack mobile app version 2.1 is designed to augment treatment with the CervicalStim™, SpinalStim™ and PhysioStim™ bone growth stimulators by allowing patients to remotely share PROM data, in addition to device usage data, with their treating physician,” said Kevin Kenny, President of Global Orthofix Spine. “We are proud to be the first in the bone growth stimulation market to be able to deliver tools to support physician remote patient monitoring endeavors to aid in a joint vision of improving patient outcomes.”

“We know that patients who take an active role in their follow-up care have an overall better recovery experience and outcomes,” said Dr. Peter Whang, Associate Professor, Department of Orthopaedics and Rehabilitation, Yale University School of Medicine. “The STIM onTrack mobile app version 2.1 is very beneficial for tracking adherence to their treatment plan, and the addition of the PROM questionnaire feature provides us with even more insights on how the patient is responding in their home setting, not just when they visit our office.”

Prescribing providers have access to their patients’ PROM submissions via the proprietary Orthofix physician portal. Remote patient monitoring CPT codes are potentially available to prescribing practitioners if they meet the requirements for reimbursement. The STIM onTrack mobile app version 2.1 is an upgrade of the original STIM onTrack mobile app that was first introduced in 2017. The app is free and supported by iOS and Android devices.

 

Hot this week

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

0
Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

0
EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.

Boston Scientific Obtains CE Mark for ACURATE Prime Aortic Valve System

0
The ACURATE Prime aortic valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.

Noctrix Health Announces New CMS Reimbursement Codes and Payment for Nidra Tonic Motor Activation Therapy for Restless Legs Syndrome

0
Nidra TOMAC Tonic Motor Activation Therapy, which was authorized for marketing in the United States last year following its designation as a "Breakthrough Device" by the US Food & Drug Administration (FDA), remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS.

Haemonetics Announces Full Market Release for VASCADE MVP® XL Vascular Closure System

0
Haemonetics notes the VASCADE MVP XL system is now available to U.S. hospitals as the newest addition to Haemonetics' VASCADE® portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis.

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York, No. Carolina
United States
Phone Number: 1.561.316.3330