News | Heart Failure | June 15, 2021

VoluMetrix's NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients.


June 15, 2021 — VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that its NIVAHF device has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA).

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients, and represents the company's flagship application for its Non-Invasive Venous waveform Analysis (NIVA) technology. Development of NIVAHF, which is being prepared for submission for De Novo regulatory clearance, is supported by a Fast-Track grant provided by the National Institutes of Health (NIH) and LaunchTN SBIR/STTR Matching Fund Program. As part of the Breakthrough Device program, FDA will work closely with VoluMetrix to advance pre-commercial development of NIVAHF and prioritize the review of subsequent regulatory submissions.

The intended purpose of the NIVAHF device is to provide a proprietary NIVA Score that corresponds to a pulmonary capillary wedge pressure, or PCWP. Currently, this clinically important value can only be obtained through invasive catheterization of the heart and vasculature. NIVAHF provides a non-invasive solution in heart failure care — taking this from hospital to home.

"We are thrilled that FDA has recognized NIVAHF as a Breakthrough Device with important prospective clinical applications," said Kyle Hocking, Ph.D., President & CEO of VoluMetrix. "NIVAHF is the culmination of our organization's talent, intellect, passion, and hard work. It represents the first of many potential vehicles for our NIVA vital monitoring technology, and we look forward to working closely with regulators to expedite its development and regulatory review. Ultimately, our mission is to improve the care experience for as many heart failure patients as possible, as quickly as possible. This designation is a powerful milestone in that journey, and we are grateful for it."

The NIVA technology represents a major innovation in vital monitoring technology. NIVA was developed to optimize hemodynamic assessment in three key ways: signal capture (using a non-invasive wrist sensor), signal deconstruction (mapping individual amplitudes within a patient's waveform), and signal decoding.

What is the Venous Waveform?
The venous waveform is an energy-based signal generated by the heart and respiratory activity that reflects numerous physiologic conditions, including pulse rate and respiration, as well as intravascular and extravascular dynamics.

About Breakthrough Device Designation
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request ("De Novo request").

This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

For more information about this designation: https://www.fda.gov/media/108135/download

For more information: www.volumetrix.com

 

Related Content

News | Heart Failure

August 5, 2022 — For people with coronary heart disease, beta-blockers can improve survival and quality of life, while ...

Home August 05, 2022
Home
News | Heart Failure

July 27, 2022 — The world’s first HIV-positive to HIV-positive heart transplant has been successfully performed at ...

Home July 27, 2022
Home
News | Heart Failure

July 27, 2022 — Researchers from RCSI University of Medicine and Health Sciences have developed a new lab-based model of ...

Home July 27, 2022
Home
News | Heart Failure

July 20, 2022 — Sequana Medical NV, a pioneer in the treatment of drug-resistant fluid overload in liver disease and ...

Home July 20, 2022
Home
News | Heart Failure

July 15, 2022 — The American Heart Association, the leading voluntary organization devoted to longer, healthier lives ...

Home July 15, 2022
Home
News | Heart Failure

July 13, 2022 — Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today ...

Home July 13, 2022
Home
News | Heart Failure

July 12, 2022 — Pesticides and heavy metals in soil may have detrimental effects on the cardiovascular system, according ...

Home July 12, 2022
Home
News | Heart Failure

July 7, 2022 — Tenaya Therapeutics, Inc., a biotechnology company with a mission to discover, develop and deliver ...

Home July 07, 2022
Home
News | Heart Failure

June 29, 2022 — A spiral wave of electrical activity in the heart can cause catastrophic consequences. One spiral wave ...

Home June 29, 2022
Home
News | Heart Failure

June 29, 2022 — Adult survivors of cancer have a higher risk of heart failure and other cardiovascular diseases (CVD) ...

Home June 29, 2022
Home
Subscribe Now