It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.

Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.

The U.K. National Institute for Health and Care Excellence has offered a thumbs-up for eight digital technologies to help patients with asthma manage their conditions. The sponsors of these products have three years to turn out enough evidence to persuade NICE to fully endorse those products, after which these platforms could have access to a market of more than five million patients.

Stereotaxis Inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, marking a key step in the company’s effort to evolve from a niche robotics supplier into a more vertically integrated electrophysiology technology provider. The approval positions Magic as Stereotaxis’ first proprietary robotic ablation catheter in the U.S. and follows a series of regulatory and commercial milestones in recent months that reset the company’s growth narrative.

Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.

Over the last year, diabetes technology saw significant changes, including the acceleration of patch pumps, ever-smaller continuous glucose monitors (CGM), implanted CGMs and increased interest in devices that measure additional chemicals in blood without needles.

The U.K. National Institute for Health and Care Excellence posted a draft update on its recommendations for ovarian cancer testing, proposing several changes that may lead to earlier intervention in the ovarian cancer disease cycle.

IPOs top the list of the big stories in 2025 in med tech. Thirty med-tech companies went public, raising nearly $12 billion, two orders of magnitude more than in 2023 and almost 20 times more than raised in 2024.

The U.S. Centers for Medicare & Medicaid Services announced that several Medicare administrative contractors have formally withdrawn local coverage determinations for skin substitutes. There are questions, however, as to whether this will bring an end to excess spending on these products even though the agency has capped the rate paid for entire classes of products.

The level of investment in Europe’s med-tech sector in 2025 did not materialize as many had hoped at the beginning of the year. Reciprocal tariffs introduced by the U.S. government created an uncertain macroeconomic environment, curtailing dealmaking and slowing financing activity. Nevertheless, amid uncertainty, there were some bright spots as medical devices remain essential, and investors know how to navigate market cycles.