For individuals with major depressive disorder (MDD) that does not respond to pharmacotherapy, recent decisions by the U.S. FDA enabling at-home use of neuromodulation devices may provide a bright spot in dark days. Neurolief Ltd. received FDA premarket approval for Proliv Rx, a physician-directed, brain neuromodulation therapy indicated for use as an at-home adjunctive treatment for adults with MDD who failed to respond adequately to at least one previous antidepressant on Jan. 7. That decision follows the December 510(k) clearance for at-home use of the Flow brain-stimulation device by Flow Neuroscience AB as either a monotherapy or as an adjunctive treatment.

Haemonetics Corp. acquired Vivasure Medical Ltd. for €100 million (US$116 million) cash plus up to an additional €85 million (US$99 million) in contingent payments based on sales and other milestones. The deal continues nearly four years of increasing investment in Vivasure by Haemonetics in support of its latest version of the Perqseal vessel closure device.

In a big week for W.L. Gore & Associates Inc., the company reported plans to acquire Conformal Medical Inc. and received U.S. FDA approval for its Viabahn Fortegra venous stent for use in the inferior vena cava, iliac and iliofemoral veins.

Genedx Holding Corp. launched Genomedx Prenatal, its whole genome sequencing test, to provide more definitive diagnoses of the causes of fetal abnormalities identified by ultrasound. By combining the company’s decade of experience in prenatal exome testing and its massive Genedx Infinity rare disease dataset, the test can determine not just whether a pregnancy has a risk of a genetic disorder but whether the fetus actually has a genetic disorder.

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.

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.

Four optimization trends dominated the med-tech industry in 2025. Growth-driven acquisitions propelled major players into hot markets, while strategic realignments at several large companies prompted notable exits as well as a few tuck-in deals. Spin-offs continued their mixed performance, with several companies on track for significant splits and others changing plans. Private equity entered — and exited — with leveraged buy outs, and a record-setting cash out.

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.

Edwards Lifesciences Corp. received U.S. FDA approval for its Sapien M3 mitral valve replacement system, making it the first transcatheter therapy utilizing a transseptal approach to be indicated for treatment of mitral regurgitation (MR). The Sapien M3 transcatheter mitral valve replacement system is indicated for the treatment of patients with symptomatic moderate-to-severe or severe MR or symptomatic mitral valve dysfunction who are deemed unsuitable for surgery or TEER by a multidisciplinary heart team.