LAST UPDATED: November 11, 2026

Need to get familiar with the focused ultrasound market?

Surgery without a cut was science fiction, now it's here. Focused ultrasound can now treat a tremor, a prostate tumor or a varicose vein with sound waves alone. The hard part is getting expensive systems into more hospitals and getting insurers to pay for each treatment. This report covers the whole market as it stands today.

  • 190+ pages
  • 12 sections
  • verified data only
Need to get familiar with the focused ultrasound market? market report cover

What’s inside the report?

12 sections to help founders and investors understand the focused ultrasound market with clarity

Radar map of the focused ultrasound market showing which companies count as part of it, which sit on its edge and which stay outside: Who is in focused ultrasound, and who stays outside? (Focused Ultrasound Market, NewMarketPitch)
Radar map of the focused ultrasound market showing which companies count as part of it, which sit on its edge and which stay outside: Who is in focused ultrasound, and who stays outside? (Focused Ultrasound Market, NewMarketPitch)
Market Definition

What is this market, exactly?

Focused ultrasound is often mixed up with the ultrasound scans used to look at a baby or a heart, so we start by drawing a clear line.

A system that heats or breaks up tissue deep in the body with focused sound waves is in. So is a device that gently stimulates the brain, or one that briefly opens the blood-brain barrier so a drug can get through. An ultrasound scanner used only for imaging is out, and so are treatments that use lasers, radio waves or microwaves instead of sound.

That way, every number and every company in the report refer to the same market.

Timeline of the dated steps showing how the focused ultrasound market is moving, with one key signal: HistoSonics carried its tumor killing ultrasound into Europe (Focused Ultrasound Market, NewMarketPitch)
Timeline of the dated steps showing how the focused ultrasound market is moving, with one key signal: HistoSonics carried its tumor killing ultrasound into Europe (Focused Ultrasound Market, NewMarketPitch)
Market Opportunity

Why this market now?

Focused ultrasound is a real business, but still a narrow one: a handful of approved uses, a few large systems, and companies working to make them easier to install and run.

We've found a lot of interesting signals. For example, in November 2025, EDAP won FDA 510(k) clearance for new imaging and planning software on Focal One, its robotic system for treating prostate cancer. And in February 2026, Insightec received a Canadian license for Exablate Prime, its newest system for treating essential tremor, which works with MRI scanners from Philips, GE and Siemens. The leaders are not chasing new miracles. They're making the treatments they already sell faster and easier for more hospitals to offer.

In this section, we look at which treatments already get paid for, which ones are getting close, and what it takes for a hospital to buy a system.

Bar chart of the focused ultrasound market size year by year to 2036, with its growth rate: How much bigger can focused ultrasound get? (Focused Ultrasound Market, NewMarketPitch)
Bar chart of the focused ultrasound market size year by year to 2036, with its growth rate: How much bigger can focused ultrasound get? (Focused Ultrasound Market, NewMarketPitch)
Market Size

How big could this market get?

Focused ultrasound market sizes online often include diagnostic ultrasound or every kind of tumor ablation, so the numbers rarely match.

We don't reuse someone else's figure. We build our own estimate, compare it with outside sources and spell out every assumption, so you can see how we got there.

We also show how the number changes if new uses take longer to get approved, or arrive sooner.

Matrix of the problems focused ultrasound customers still face, rated for each type of buyer: Which focused ultrasound problems are still unsolved? (Focused Ultrasound Market, NewMarketPitch)
Matrix of the problems focused ultrasound customers still face, rated for each type of buyer: Which focused ultrasound problems are still unsolved? (Focused Ultrasound Market, NewMarketPitch)
Pain Points

What are the pain points, and for whom?

Many patients with a tremor, a tumor or prostate cancer would rather avoid surgery, but few hospitals offer anything in between.

We compare six kinds of focused ultrasound companies, from MRI-guided brain treatments to prostate systems, histotripsy and brain stimulation. Their buyers include academic hospitals, urology groups, cancer centers and drug companies. Then we rank what matters most to them, like the cost of the system, time spent in the scanner, and whether insurers will pay.

This shows which treatments justify buying a system, and which ones still need more evidence.

Comparison table of the tech offered by leading focused ultrasound companies: Who has the most complete focused ultrasound tech today? (Focused Ultrasound Market, NewMarketPitch)
Comparison table of the tech offered by leading focused ultrasound companies: Who has the most complete focused ultrasound tech today? (Focused Ultrasound Market, NewMarketPitch)
Tech & Infra

What is the latest tech and infrastructure?

Aiming sound at a small spot deep in the body, through skin or skull, takes precise hardware, live imaging and careful planning software.

We go through the stack piece by piece: the transducers that shape the beam, the MRI or ultrasound imaging that guides it, the planning software, and the microbubbles used to open the blood-brain barrier. We also show where things get stuck, like long sessions in a busy MRI scanner, thick skulls that weaken the beam, and organs that move when the patient breathes.

You'll see which treatments the technology already handles reliably today, and which ones are still in trials.

Map of focused ultrasound business models with company logos: How does money really flow in focused ultrasound? (Focused Ultrasound Market, NewMarketPitch)
Map of focused ultrasound business models with company logos: How does money really flow in focused ultrasound? (Focused Ultrasound Market, NewMarketPitch)
Value Creation

How is value created and monetized exactly?

System sales, per-treatment fees, disposables, service contracts, shared-revenue deals with hospitals and partnerships with drug companies: focused ultrasound companies make money in several ways.

We compare who pays and what it costs. A hospital pays a lot for a system, then needs enough patients to keep it busy. Some makers place or rent the system instead, and earn a fee on every treatment. Brain stimulation startups may sell to clinics or partner with drug companies, and blood-brain barrier players depend on drugs that need help reaching the brain.

You'll see which models still work when a hospital treats only a few patients a week, and which ones need insurers to pay first.

Table of the events that could slow the focused ultrasound market, with their odds and impact: What are the biggest threats to the focused ultrasound market? (Focused Ultrasound Market, NewMarketPitch)
Table of the events that could slow the focused ultrasound market, with their odds and impact: What are the biggest threats to the focused ultrasound market? (Focused Ultrasound Market, NewMarketPitch)
Market Challenges

What could slow this market down?

Some brakes are obvious: expensive systems, insurers that move slowly, and doctors who need training before they trust a new treatment.

Others are easier to miss. MRI time is scarce in many hospitals. Each new use needs its own trial and its own approval. Surgery, radiation and other ablation methods already have loyal users. And brain stimulation and drug delivery are still in trials, so their timelines are hard to predict.

We take the risks one at a time, rate how likely each one is, and explain which companies would feel it first.

Timeline of the events that pushed the focused ultrasound market forward, with their impact: What pushed the focused ultrasound market forward, year after year? (Focused Ultrasound Market, NewMarketPitch)
Timeline of the events that pushed the focused ultrasound market forward, with their impact: What pushed the focused ultrasound market forward, year after year? (Focused Ultrasound Market, NewMarketPitch)
Growth Drivers

What are the growth drivers in this market?

Growth here depends on what gets approved and paid for next, so we go through each driver.

Some are easy to see: aging patients, demand for treatments without cuts or hospital stays, and better imaging. Others feed each other. Each newly approved use helps a hospital fill a system it already owns. More treated patients give insurers the evidence they ask for. And if drug companies start relying on ultrasound to get drugs into the brain, the whole field gains a new kind of customer.

Before building or investing, you should know what it takes for a hospital to buy a system, and to keep enough patients going through it.

Bar chart of where investors put their money in focused ultrasound, by category: Where did focused ultrasound investors put their money this past year? (Focused Ultrasound Market, NewMarketPitch)
Bar chart of where investors put their money in focused ultrasound, by category: Where did focused ultrasound investors put their money this past year? (Focused Ultrasound Market, NewMarketPitch)
Investor Bets

Where are investors placing their bets today?

Investors used to see focused ultrasound as one MRI-guided tremor treatment. Now they also fund brain stimulation, histotripsy and drug delivery.

We compare recent rounds for tumor treatment, brain-related uses and devices that help drugs reach the brain. We also look at whether investors prefer companies with an approved product and revenue, or earlier teams with a bigger idea, and which newer bets, like headsets that stimulate the brain, are getting funded.

You'll see which focused ultrasound companies investors are backing today, from approved systems to brain stimulation startups. We also look at what a younger team needs to show, from trial data to paying hospitals, before it can raise.

Market grid of the top focused ultrasound startups and companies by segment: Who are the top players in focused ultrasound today? (Focused Ultrasound Market, NewMarketPitch)
Market grid of the top focused ultrasound startups and companies by segment: Who are the top players in focused ultrasound today? (Focused Ultrasound Market, NewMarketPitch)
Top Players

Who are the top startups and companies?

Insightec and EDAP sell the systems most doctors have heard of, one for tremor and the other for prostate cancer, but they're only one layer of this market.

Many of the most interesting players are still small. Some are building devices that open the blood-brain barrier for brain cancer or Alzheimer's drugs. Others make wearable systems that stimulate the brain without surgery, pair ultrasound with a drug to treat tumors, or treat varicose veins and thyroid nodules in an outpatient room.

They're hard to compare because each one targets a different organ, uses a different kind of imaging, and sits at a different stage, from lab tests to approved products. From the outside, a good early result in a few patients can look a lot like a finished product.

Below, you'll find the market grids and ecosystem maps we've built to show who treats what, and where newer companies are getting in.

Table of the warning signs shown by leading focused ultrasound companies: Which focused ultrasound companies have shown warning signs lately? (Focused Ultrasound Market, NewMarketPitch)
Table of the warning signs shown by leading focused ultrasound companies: Which focused ultrasound companies have shown warning signs lately? (Focused Ultrasound Market, NewMarketPitch)
Startup Killers

What could kill a startup in this market?

Approval is only the start. A focused ultrasound company needs a hospital to buy an expensive system and an insurer to pay for every treatment.

So we studied why focused ultrasound startups fail or stall. Some won approval for a use too small to fill a system's calendar. Others ran out of cash between a promising trial and the next one. And some built a great device that only worked inside a scanner few hospitals could spare.

If you're building, you'll see why choosing the first treatment, and planning for payment early, matters as much as the hardware. If you're investing, you'll know what to check about how often systems are used, trial timelines and how long the cash lasts.

Scorecard showing what sets the leading focused ultrasound company apart: How did Insightec take the lead in image-guided focused ultrasound? (Focused Ultrasound Market, NewMarketPitch)
Scorecard showing what sets the leading focused ultrasound company apart: How did Insightec take the lead in image-guided focused ultrasound? (Focused Ultrasound Market, NewMarketPitch)
Startup Strategies

How do you win in this market?

Profound Medical, Theraclion, Nudge… a few focused ultrasound companies are pulling ahead, each at a very different stage.

Profound Medical treats prostate cancer with an MRI-guided device placed in the urethra, and US doctors got permanent billing codes for it in 2025. Theraclion sells an ultrasound system that treats varicose veins in Europe. Nudge raised $100M to build ultrasound that stimulates the brain without surgery, and is still in clinical trials. One has a path to payment, one has an outpatient niche, one has a big idea and plenty of cash. None has proven its model across many hospitals yet.

We'll look at how these teams picked their first treatment, and what each path teaches about getting from approval to steady sales.

Questions?

Who is this market report actually for?+

It's for founders, investors, hospitals, device makers, drug companies and strategists who want a clear view of focused ultrasound.

Use it to decide which treatment to build for first, to compare selling systems with charging per treatment, to weigh brain uses against tumor treatment, or to understand demand, technology, funding, competitors and risks across the whole market.

How many pages are in the report?+

It has 190+ pages. It is designed to be comprehensive enough to support serious market evaluation, while still being fast to read and easy to use.

We prioritize signal, structure, and visual clarity over unnecessary length.

What do you include in the focused ultrasound market?+

We define the focused ultrasound market as medical technologies that concentrate ultrasound energy to produce a therapeutic effect.

We include focused-ultrasound systems for tissue treatment, neuromodulation and targeted drug-delivery support.

We exclude diagnostic ultrasound and therapies using non-ultrasound energy sources.

Do you list your sources clearly?+

Yes. All key data points and assumptions are explained and sourced in the document.

All sources are tier-1: company filings, funding databases, public datasets, expert interviews, industry reports, etc.

Is the data up to date?+

Yes. The report was last updated on November 11, 2026 with the latest market signals.

Is this a one-time payment?+

Yes. This is a one-time purchase. There is no subscription required to access the document.

I want to buy several market reports, can I get a discount code?+

Yes. You can use NEWMARKET for 20% off when purchasing two reports, or NEWMARKETMAX for 30% off when purchasing five or more.

I’m interested in a market but I can’t find it here+

If a market you care about is not currently on the list, email us at team@newmarketpitch.com and we may be able to cover it.

I have more questions for you+

No problem. You can reach out directly and we respond within 24 hours.

LAST UPDATED: November 11, 2026

The focused ultrasound market, without the blind spots

A focused ultrasound treatment can impress surgeons and patients, and the system can still sit idle if the hospital can't fill its schedule. This report covers the whole focused ultrasound market, from size and buyers to technology, payment, business models, funding, key players, risks and the openings that remain.

PRO
$49
One-time payment
  • ✓ Market Definition
  • ✓ Market Opportunity
  • ✓ Market Size
  • ✓ Pain Points
  • ✓ Tech & Infra
  • ✓ Value Creation
  • ✓ Market Challenges
  • ✓ Growth Drivers
  • ✓ Investor Bets
  • ✓ Top Players
  • ✓ Startup Killers
  • ✓ Startup Strategies
PRO+
$79
One-time payment
  • ✓ Market Definition
  • ✓ Market Opportunity
  • ✓ Market Size
  • ✓ Pain Points
  • ✓ Tech & Infra
  • ✓ Value Creation
  • ✓ Market Challenges
  • ✓ Growth Drivers
  • ✓ Investor Bets
  • ✓ Top Players
  • ✓ Startup Killers
  • ✓ Startup Strategies
PRO++
$99
One-time payment
  • ✓ Market Definition
  • ✓ Market Opportunity
  • ✓ Market Size
  • ✓ Pain Points
  • ✓ Tech & Infra
  • ✓ Value Creation
  • ✓ Market Challenges
  • ✓ Growth Drivers
  • ✓ Investor Bets
  • ✓ Top Players
  • ✓ Startup Killers
  • ✓ Startup Strategies
Use code MARKETPITCH for 10% off your order