Medical device tax permanently repealed

Departments - Regulatory

Breakthrough designation for heart failure screening test; Medical device safety

January 30, 2020


The Affordable Care Act’s 2.3% medical device tax – to be paid by the medical device manufacturer or importer – was permanently repealed at the end of 2019.

Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker says, “With the end of this burdensome tax, the U.S. medtech industry can do what it does better than anyone else in the world: develop life-changing innovations that save and improve patients’ lives, and create high-paying, high-tech jobs to keep the American economy booming.”

The medical tax went into effect in January 2013 and opponents lobbied to repeal it because of its negative impact on jobs and innovation. Intended to raise $30 billion throughout 10 years to pay for healthcare reform, Congress suspended the tax starting in 2016, renewing the suspension each year through 2019.

Andre’ DiMino, CEO of ADM Tronics Unlimited Inc. (ADMT), has been a staunch and vocal opponent of the medical device tax since its inception. Upon the permanent repeal, DiMino says, “Just in the few days since the repeal was announced, we have received numerous inquiries at ADMT for quotations for new engineering, development, and manufacturing projects for medical devices from our customers. We believe the coming months and years will be fruitful for our company as well as the overall medical device industry.”

Medical device safety

Revised ISO 14971 promotes safety of devices and equipment used for medical purposes. It covers injury risks related to patients, operator, and other persons, as well as potential damage to property, equipment, and the environment. The revision clarifies the standard’s technical requirements by including more detailed information on steps manufacturers must take. It also includes new and updated terminology to reflect the current market needs. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel.

For ISO 14971, Medical Devices, Application of Risk Management to Medical Devices specifies the terminology, principles, and process for managing the risks of medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.


Breakthrough designation for heart failure screening test

The U.S. Food and Drug Administration (FDA) granted Eko breakthrough status for an electrocardiogram-based (ECG) algorithm that could provide an easily accessible screening test for heart failure. The algorithm analyzes 15 seconds of ECG data collected from the Eko DUO digital stethoscope during a physical exam and helps identify reduced left ventricular ejection fraction, a measure commonly used to diagnose patients with heart failure.

Eko’s low ejection fraction algorithm employs a deep neural network developed in collaboration with Mayo Clinic.