Four Major Trends in Medical Technology for the Second Half of 2025: M&A Recovery, Renal Denervation, MDUFA Negotiations, and the Hugo Surgical Robot

Midway through 2025, medical device companies are gaining better visibility into the second half of the year.

After a slow spring for deals, M&A activity is heating up again. Medtech companies are preparing for several major product launches: Medtronic is stepping up its challenge to Intuitive Surgical's surgical robots, and Medicare has expanded coverage for device-based therapies for hypertension.

Meanwhile, the U.S. Food and Drug Administration (FDA), under new leader Martin Makary, is beginning to outline its regulatory path and negotiate the fees it will charge the industry over the coming years.

Despite lingering uncertainties ahead—such as the exact shape of fall tariff policies—device companies are still advancing their growth strategies as planned.

Here are four trends MedTech Dive is watching for the second half of 2025:

1. M&A

M&A deals are always a topic worth watching in medtech, because acquisitions are one of the core engines driving industry growth.

This year, however, the M&A environment has been uneven. After several large acquisitions in the early months—such as Stryker's nearly $5 billion purchase of Inari Medical—deal activity nearly ground to a halt as market volatility from the Trump administration's erratic tariff policies took hold.

For months, there were few notable deals. Still, several experts told MedTech Dive earlier that spending would pick up in the second half—and those predictions quickly came to pass.

In July, BD and Waters announced a $17.5 billion merger agreement, combining BD's Biosciences and Diagnostics Solutions business with Waters. The deal is poised to be the industry's largest M&A of the year and kicked off a wave of announcements.

With roughly four months left in 2025, M&A remains a key point to watch.

RBC Capital Markets analyst Shagun Singh told MedTech Dive in June that companies will remain opportunistic no matter how much uncertainty exists in the market.

"M&A is just going to continue. I think it's the lifeblood of medtech," Singh said. "If you have a multibillion-dollar market opportunity in front of you and the asset is right there, you're not going to walk away because of tariffs."

Singh added that the deal space in the sector could be fairly wide open, with multiple attractive markets and new technologies worth betting on.

"Deals will be across the board," Singh said. "I really think it's going to be very diversified."

2. Renal denervation

Medicare's national coverage determination (NCD) for renal denervation will expand access to this minimally invasive procedure for patients with uncontrolled hypertension, while also helping to define the size of an important emerging market for Medtronic.

The potential market for the procedure is substantial: nearly half of U.S. adults have hypertension, but only about a quarter have their blood pressure under control.

"The final NCD will clearly define the Medicare-reimbursable population, which has significant implications for the total addressable market opportunity," said Mizuho analyst Anthony Petrone.

Medtronic has previously forecast that renal denervation will become one of its fastest-growing drivers once the Centers for Medicare & Medicaid Services (CMS) reimbursement policy is in place. The final NCD memo is expected in October. With the deepest clinical dataset and a large sales force behind it, "Medtronic will be the biggest player in this space," Petrone said.

The FDA approved two renal denervation systems in late 2023 for patients whose blood pressure cannot be effectively lowered by lifestyle changes and medication. Medtronic's Symplicity Spyral system received FDA approval despite resistance from an external FDA advisory panel, which questioned the device's effectiveness and the appropriate patient population.

Medtronic's device uses radiofrequency energy to ablate overactive nerves around the renal arteries, which supply blood to the kidneys. The other FDA-approved technology is Recor Medical's Paradise system, which uses ultrasound energy. Recor is a subsidiary of Otsuka Medical Devices.

Although Medtronic and Recor have a first-mover advantage in the market, more medtech companies are positioning in renal denervation. Boston Scientific acquired SoniVie this spring—the company is developing the ultrasound-based Tivus system. Boston Scientific, which previously held a 10% stake in SoniVie, agreed to pay up to $540 million to acquire the remaining equity. South Korea's DeepQure and precision diagnostics company Geneticure are also investing in renal denervation technology.

Provider comments CMS received during the public comment period show broad industry support for expanding access to the procedure. The American College of Cardiology and the American Heart Association also recently included renal denervation in their hypertension management guidelines for the first time.

Still, Needham analyst Mike Matson noted that clinical adoption may take time to ramp up as physicians undergo procedure training and referral pathways are established.

"It's definitely going to be a high-growth market. It'll be a little slow at first because even with reimbursement, it's a brand-new procedure type," Matson said. "But it should gain momentum over time and become a fairly sizable market and growth driver for Medtronic and also Otsuka."

3. MDUFA

The FDA's device center has begun preliminary proceedings to determine how much funding it will receive from the medtech industry between 2027 and 2032.

The FDA held its first public hearing in early August to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA), which allows the agency to supplement congressional appropriations with industry fees over a five-year period.

HPS Group regulatory consultant Steven Grossman wrote in an email that the meeting was the first step in a process expected to last 15 months.

"The most important message is that there is broad support for renewal," Grossman wrote. "The specifics are useful in understanding the asks of different stakeholders, but nobody showed their cards."

The current MDUFA V agreement, which expires in September 2027, allocated $1.78 billion to $1.9 billion to the FDA's Center for Devices and Radiological Health (CDRH), depending on whether the center met certain hiring targets. By comparison, the FDA received about $1.1 billion during the previous five-year period.

For MDUFA VI, the FDA is seeking more funding because the Trump administration has proposed cuts to appropriations for the FDA and other health agencies.

CDRH Director Michelle Tarver laid out the case for additional funding at the meeting.

"MDUFA VI needs critical resources," Tarver said. "A modern CDRH driven by gold-standard science needs great people."

The future direction of the MDUFA program was one of the concerns raised at the meeting. Diana Zuckerman, president of the National Center for Health Research, noted that the FDA must spend at least as much in appropriations as it did when the user fee act took effect. If it fails to do so, industry could reduce its fees.

"We don't want that to happen," Zuckerman said in an interview. "Then there wouldn't be enough money for any program."

Zuckerman and other patient advocates called for increased user fee funding and for some of the money to be used for post-market safety surveillance of medical devices. They also called for greater transparency in the user fee process.

The FDA is seeking public comment through September 4, after which it will begin a series of meetings to reach an agreement with the medical device industry. Zuckerman said she expects more input from external stakeholders such as patients and medical groups.

"Device issues have been underappreciated for decades," Zuckerman said. "Is this the year people pay more attention?"

4. Medtronic's Hugo surgical robot

If Medtronic wins FDA approval to launch the Hugo system in the U.S. this year, it will become the first major medtech company to challenge Intuitive Surgical's nearly 25-year dominance in soft-tissue robotic surgery.

The company submitted the Hugo robot for urology procedures to the FDA in the first quarter of this year. It also completed enrollment for studies supporting U.S. hernia and benign gynecology indications and received clearance to start an oncology gynecology trial.

Analysts expect Medtronic to win some Hugo orders from health systems, but they are skeptical about how much market share it can take from the industry leader.

"We don't expect Intuitive to lose meaningful share when Hugo launches in the U.S.," said BTIG analyst Ryan Zimmerman.

With the rollout of the technologically advanced da Vinci 5 robot, which was first introduced in early 2024 and is now launching at scale, Intuitive has "leapfrogged" its competitors, Zimmerman said. "The ecosystem around DV5 is so strong that it's going to be hard to break that monopoly," he said.

Needham's Matson noted that many surgeons are trained on the da Vinci system, which has a large installed base and years of clinical data supporting the technology. When Medtronic eventually enters the U.S. market, "it's going to be an uphill battle," the analyst said.

Mizuho's Petrone believes Hugo could win share from hospitals looking to replace older da Vinci systems, while the robot may also appeal to surgeons loyal to Medtronic's surgical instrument product line.

As more procedures shift to robotic assistance, the growing prevalence of da Vinci has eroded Medtronic's instrument business. Medtronic CEO Geoff Martha said at an investor conference in May that Hugo is expected to help the surgical business return to growth.

When the company announced in July that its LigaSure vessel sealing instrument received CE marking in Europe for use in robot-assisted procedures with the Hugo robot, Medtronic said it expects the robot to enter the U.S. market later in its current fiscal year, which ends in April 2026.