The Impedimed Limited (ASX: IPD) share price was off to a flying start this morning, up 13% at market open.
The positive price movement came as the medical technology company announced it received Food and Drug Administration (FDA) clearance for a new heart monitoring device in the United States.
At the time of writing, shares in the company are up 8.7%, trading at 12.5 cents. By comparison, the S&P/ASX All Ordinaries Index (ASX: XAO) is 0.08% higher.
Let’s take a closer look at today’s news and what it means for the Impedimed share price.
Impedimed’s new product
In a statement to the ASX, Impedimed advised it has received FDA 510(k) clearance for its SOZO device to include a heart failure index (HF-Dex) as a monitoring tool for patients living with heart failure.
The 510(k) clearance is a requirement for launching new medical products in the US.
Impedimed says the HF-Dex can measure fluid levels in people using a 30-second, non-invasive test. According to the company, the product presents the data in graphical format for a quick assessment and is most useful in conjunction with other clinical data.
In addition, the Impedimed said the product “has been demonstrated in peer-reviewed publications and abstracts accepted at internationally renowned cardiology conferences”, such as the American College of Cardiology and the Heart Failure Society of America.
What did management say?
Commenting on the news, Impedimed CEO Richard Carreonsaid said:
We are very pleased with this expanded clearance for SOZO that includes our heart failure index. This is a major step forward in SOZO becoming the standard of care for the management of heart failure patients.
The use of HF- Dex will provide clinicians unparalleled insights into the extracellular fluid accumulation in heart failure patients that has not otherwise been readily available to them before.
Impedimed share price snapshot
Over the past 12 months, the Impedimed share price has increased 212%, although it’s up just 4% year-to-date. Today’s news regains the ground lost yesterday when the company’s shares fell 11.5%.
Impedimed has a market capitalisation of $171.5 million.