The 2020 outlook for medical products and the medical device industry in the U.S. is positive, but Moody’s lowered its growth forecast due to weakening macroeconomic conditions in its annual report on the industry.

Moody’s said the medtech industry’s expected earnings before interest, tax, depreciation and amortization (EBITDA) will grow from 5% to 6% over the next 12 to 18 months, which is a slight drop from the previous 5.5% to 6.5% growth projection from seven months ago, according to the report.

Last year’s outlook was similarly positive, with a projected EBITDA growth of between 4.5% and 5.5% for companies on an organic basis.

The investor service said the drop in the forecast reflects a softening macroeconomic growth outlook, limited incremental synergies from large acquisitions over the past couple of years and some product challenges, namely the lower sales of paclitaxel-coated stents after reports of increases in longer-term mortality for patients treated with the devices.

In August, the FDA asked healthcare providers for more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons and urged physicians to carefully consider when to use them.

Moody’s added that potential revisions to the outlook could include a change to “stable” if the expected EBITDA grows between 0% and 4% over the next 12 to 18 months. A change to “negative” could be on the cards if EBITDA declines over that same time frame.

Potential game-changers in the industry include the probable U.S. medical device excise tax repeal, new product development driving revenue growth, global growth slowing and the brisk pace of mergers & acquisitions.