What 2025 reveals about medtech’s next leap in 2026

No one can predict what the medical device industry will look like in 2026. Still, the events of 2025 provide meaningful clues. Significant developments, from sweeping job cuts at the US Food and Drug Administration (FDA) to strong initial public offerings (IPO) and a slew of M&A activity, offer a clear view of how the industry may play out in 2026, highlighting the challenges and opportunities on the horizon.  

Medical Device Network spoke with a range of observers to get a sense of what 2026 may hold.  

Cardiology and orthopaedics were among the most significant market segments in the medical device space in 2025 and will continue to be in 2026, according to Charlie Whelan, senior director of consulting for medical devices at GlobalData. 

Whelan says: “These are the ones people are paying most attention to since they represent some of the biggest untapped areas for improving patient mortality and morbidity.” 

Regarding the segments’ interest levels, Whelan highlights the ongoing innovation for Johnson & Johnson (J&J) with their Shockwave Peripheral intravascular lithotripsy (IVL) System to treat calcified lesions below the knee (BTK) in individuals with peripheral artery disease (PAD). J&J recently shared data from a post-market trial that included a significant proportion of those diagnosed with chronic limb-threatening ischaemia (CLTI). According to the full cohort results, 94.8% of subjects remained free from major target limb amputation at one year, with no amputations recorded among those who did not have CLTI at baseline. 

In 2025, Boston Scientific also shared data from its FARADISE registry study, demonstrating the strong efficacy of the company’s Faradise pulsed-field ablation (PFA) system since its US launch in 2024.  

J&J’s spinoff of its orthopaedics unit was one of the biggest stories in the medtech space this year, reflecting that speciality players and investors are stepping in to run dedicated businesses in the segment, according to further analysis by GlobalData. 

Within cardiology, Whelan went on to point out the continuing strong interest levels from companies he consults with in PFA and IVL. 

PFA has continued its rapid rise since Medtronic, Johnson and Johnson (J&J) and Boston Scientific gained FDA clearance for their PFA systems, with the big players raising their fiscal year (FY) outlooks due to significant ongoing adoption rates of their respective offerings. 

Whelan says: “No one is doing anything new with PFA, but the catheters that use PFA are achieving better outcomes. This is making known existing procedures much safer and more effective. The same is true of IVL.” 

Whelan goes on to highlight that the technologies are allowing for the provision of treatment options to people that might have been good candidates in the past. 

“Being more targeted, more specific, using some of these adjunctive technologies in interventional cardiology is allowing practitioners to be more targeted and effective with the treatments that they deliver,” Whelan says. 

David Beauchamp, medical device analyst at GlobalData, highlights that the broad ongoing trend in the medical device space is a move towards minimally invasive treatment modalities, away from more invasive treatments such as open-heart surgery. 

According to Beauchamp, once PFA hit the US market, starting with the approval of Medtronic’s PulseSelect PFA system in December 2023, the atrial fibrillation (AF) treatment gained 10-20% of the market “basically overnight”. He foresees the same market share jump in the US to occur in 2025. 

“PFA’s ongoing rise is probably going to cause cryoablation to completely disappear,” Beauchamp says. 

“The cryoablation market is being completely wiped out, given the cost for cryoablation is similar to PFA, yet the outcomes are not as good.” 

Elsewhere in cardiology, Beauchamp highlights that throughout 2025, transcatheter heart valves have continued gaining traction, specifically aortic valves.  

“We're also seeing a lot of growth in mitral valve repair and replacement, and beginning to see increases in tricuspid and pulmonary valve replacement,” Beauchamp adds. 

Growth in large strategics focused on orthopaedics 

In October, Johnson & Johnson (J&J) spun off its orthopaedics business, forming a new standalone company named DePuy Synthes. 

Along with Zimmer Biomet spinning off their spine and dental business in 2022, Stuart Grant, principal consultant at British consultancy Archetype Medtech, highlights that along with Smith & Nephew and Stryker, there are now more strategics focused on orthopaedics as their main business. 

“This will be an interesting development, especially with DePuy,” Grant says. 

“The orthopaedics business probably wasn't getting all the R&D budget that J&J had to spend previously. But now, the new company’s CEO, Namal Nawana, will be able to focus all his R&D budget on orthopaedics.” 

As of October 2025, adoption of AI and robotics in sterile processing is estimated at 5–15 percent of CSSDs worldwide. Hospitals using AI-driven systems report sterilisation cycle turnaround times reduced by up to 35 percent.

AI also improves predictive maintenance. Systems continuously monitor washers, sterilisers, and other equipment, anticipating breakdowns and scheduling repairs. According to Sterigene (France), AI-based maintenance can reduce spare parts costs by 15 percent and cut both typical repair time and mean time between failures by roughly 25 percent.

Reflecting on other trending areas, Ashley Clarke, senior medical analyst at GlobalData, highlights that more closed-loop neuromodulation devices are expected to gain regulatory approval.  

“These devices are adaptive and have shown improved outcomes, and show promise for replacing traditional devices,” she says. 

Clarke also foresees the market for portable imaging devices continuing to grow, due to their “accessibility, lower cost, and ease of use”. 

Remote patient monitoring, she adds, is likely to accelerate in wound management into the new year, with pipeline innovations including devices that pair images with other sensor-based devices to track wound healing. 

GlobalData forecasts that the application of AI in healthcare will reach a valuation of $19bn by 2027. For the medtech industry, the technology remains ubiquitous, with further GD analysis revealing that medical device companies’ spending on AI was valued at $2.4bn in 2024. This figure expected to swell to $11.9bn by 2029 as the technology continues to influence areas such as imaging and diagnostics. 

Between February 2025 and December 2035, an additional 2,646 AI-driven solutions will be approved in the medical device space, as per GlobalData analysis. The approvals will span AI’s application in areas including robotic surgery, personalised treatment planning, and real-time patient monitoring.  

According to Alexandra Murdoch, senior analyst at GlobalData, AI’s ongoing growth is broadly driven by expanding regulatory approvals, embedded AI software in diagnostics, and demand for automation in imaging & surgical systems. 

Murdoch also notes that imaging original equipment manufacturers (OEM) are increasingly bundling AI as a standard feature in scanners and post-processing suites, rather than as optional add-ons. 

HeartFlow completed a $364m initial public offering (IPO) in August 2025. The company’s lead product is HeartFlow Plaque analysis, a tool that uses AI with the aim to provide clinicians with the ability to more accurately assess patients with arterial plaque buildup (atherosclerosis).  

Commenting on HeartFlow’s trajectory and IPO, Murdoch’s view is that it reflects market appetite for AI that directly ties to clinical and economic endpoints, such as fewer invasive angiograms.  

“Payers are more comfortable reimbursing AI-enabled diagnostics when there’s high quality outcomes data,” Murdoch adds. 

While AI is influencing many sectors in the medtech industry, according to Grant, there is declining investor interest in AI apps for areas such as mental health or physiotherapy. 

“Hopefully over 2026, investors are going to start looking at more physical products, the main driver being what the physical device is doing, not necessarily the fact it is sprinkled with a bit of AI,” Grant stresses.  

“I think investors are starting to become more specific about what they're looking for.” 

Adding to this, Ashley Clarke forecasts that diagnostic imaging will continue integrating AI into workflows, to “improve productivity and continue work towards earlier detection technologies.” 

Since Donald Trump became US president for the second time and appointed Robert F Kennedy Jr (RFK Jr) as head of the US department of Health and Human Services (HHS), the FDA has faced layoffs and uncertainty. These factors have become more pronounced in light of the Trump Administration’s fluctuant approach to imposing tariffs on goods essential in the production of a wide range of medical devices. 

According to Selena Yu, senior medical analyst at GlobalData, the downstream effects of layoffs seen at the FDA throughout 2025 could make medtech companies think twice about launching in the US in 2026. 

“It takes resources for manufacturers to put products through the FDA’s regulatory pathways, and if delays at the agency become more pronounced next year due to factors such as a potential lack of evaluators, some companies may begin choosing different markets in which to launch their products,” Yu says. 

With this issue more likely to hit startups hardest, given they lack the resources of bigger players in absorbing setbacks that may affect their market strategy, Yu anticipates that current dynamics may lead to more acquisitions by big companies in 2026. 

“This could be a great time for smaller companies who have great research and products but lack the funds and resources to go through the regulations in either the US or the EU, so they could get acquired by these bigger companies,” Yu says. 

In September, the FDA chose not to challenge a court ruling that dismissed IVDs, also known as laboratory-developed tests (LDT), from being regulated in the same way as medical devices. 

Yu’s views the fact the FDA chose not to challenge the court ruling as a position for the laboratory space.  

“Given all the budget cuts and delays being seen at the FDA this year, the fact LDTs are not going through the FDA may prove a net positive for innovation in the LDT space moving forward,” she says. 

While Whelan is cautiously optimistic that a lot of the good foundations put in place at the FDA’s Center for Devices and Radiological Health (CDRH) are going to remain, he highlights concerns around the FDA’s potential staffing issues.  

He questions: “Is the FDA going to have enough people? And are they going to have the right people with the right expertise? It’s currently a very challenging environment.” 

Seth Mailhot, partner at US law firm Barnes & Thornburg, says the biggest problem he has encountered since the Trump Administration imposed sweeping reform at the FDA, is finding the right person at the agency to talk to. 

“With the disruptions over the US Department of Government Efficiency (DOGE, which mandated for many of the job cuts seen in 2025) and the FDA generally, the organisation charts no longer represent who's at what position,” Mailhot says.  

“A lot of the previous process would have the FDA identify specific individuals who held what expertise. Those have now been replaced with generic email addresses to contact, which isn't as helpful when you have specific questions.” 

Mailhot’s availing concern is that lot of the departures at the FDA haven't yet filtered through all levels of the agency. 

He tells MDN that even people he’s familiar with at the FDA don’t always have an accurate idea of who's still at the agency, and who's handling what.  

“A lot of these disruptions will likely continue through the next year before we get a handle on where the substantive expertise has been lost,” Mailhot says. 

Commenting on potential review timeframes at the FDA slowing down, Mailhot continues: “While cuts were not intended to affect that, again, it’s likely going to take another year to understand how much the agency is going to be affected by the changes made across 2025.” 

Touted as a means of improving efficiencies at the FDA, Elsa, a generative AI (genAI) tool, was rolled out ahead of schedule in June. 

Mailhot holds general concerns over the application of AI at the agency, given uncertainties around whether it has been well tested enough. 

In September, the Trump Administration launched an enforcement drive against pharmaceutical companies and social media influencers who are responsible for “misleading” drug advertising. This resulted in the FDA sending thousands of letters warning pharmaceutical companies to remove misleading ads, in addition to issuing around 100 letters to other companies demanding they pull deceptive marketing. 

Adding to his doubts around AI at the FDA, Mailhot shares that a well-respected law firm wrote an alert to clients, saying that they felt that a number of those letters were generated using AI and contained incorrect information. 

“I get very concerned about the level of accuracy that AI tools are going to provide,” Mailhot continues.  

“I don't think that AI is necessarily going to provide results as effective as the FDA needs, because if inaccurate information is coming through on enforcement matters, then that's going to cause problems when they're trying to do enforcement later.” 

As we head into 2026, the emergent and ongoing trends seen throughout 2025 appear likely to continue. Regarding challenges and rising opportunities in the broader medtech industry, how these dynamics will play out remains to be seen. What is clear, is that innovation is continuing at pace. Yet across sectors, the form innovation takes will depend on how market movements, initiatives and focuses across the industry continue to evolve. 

Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.

The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.