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Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform

Business

Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform
Business

Business

Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform

2026-07-08 19:47 Last Updated At:19:50

IRVINE, Calif.--(BUSINESS WIRE)--Jul 8, 2026--

Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) approved the Dual Energy THERMOCOOL SMARTTOUCH SF Platform (DE STSF), an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter. i

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708094213/en/

“The FDA approval of the Dual Energy THERMOCOOL SMARTTOUCH SF Platform is another important milestone in what has been an incredible pace of innovation for our business,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “Our goal has always been to put the best possible technologies into physicians’ hands so they can treat increasingly complex cases with confidence. Following a successful introduction in Europe, we’re pleased to rapidly expand access to this technology in the U.S. and continue building on the momentum of one of the most active innovation periods in our history.”

Built on the THERMOCOOL SMARTTOUCH SF Platform, which has extensive clinical validation and has treated over one million patients in the U.S., the DE STSF Platform brings pulse field capability to a catheter physicians know and trust. i

The DE STSF platform is integrated with the CARTO ecosystem, including advanced mapping, imaging and PF Index guidance, helping physicians confidently deliver energy with precise contact force while supporting a predictable procedure and reproducible workflow. The dual energy capability gives physicians the versatility to use RF or PF energy based on patient anatomy and case complexity. i

"Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals," said Dhanunjaya (DJ) Lakkireddy 1, M.D., FHRS, MBA, Executive Medical Director, The Kansas City Heart Rhythm Institute. "The Dual Energy THERMOCOOL SMARTTOUCH SF Platform gives electrophysiologists the choice to use RF or PF energy based on the needs of each procedure. Having both capabilities integrated in the CARTO system can help us adapt our approach for more complex cases and plan procedures with greater confidence.”

Following FDA approval, first U.S. procedures with the DE STSF Platform are expected to begin this summer as Johnson & Johnson initiates a phased commercial rollout.

About Cardiovascular Solutions from Johnson & Johnson MedTech

Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit this website.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at https://www.jnjmedtech.com/. Follow us at @JNJMedTech and on LinkedIn.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Dual Energy THERMOCOOL SMARTTOUCH SF. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

© Johnson & Johnson and its affiliates 2026. All rights reserved. US_ELP_THER_418584

 

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

KYIV, Ukraine (AP) — Russian drones and missiles killed four people across Ukraine on Wednesday in attacks before dawn and at midday, as Moscow kept up its pressure on the capital of Kyiv in the latest phase of the over 4-year-old war.

Ukraine struck oil refineries in Russia's Saratov and Tatarstan regions, according to President Volodymyr Zelenskyy, who met with U.S. President Donald Trump on the sidelines of the NATO summit in Turkey. Trump said the U.S. would give a license to Ukraine so it could manufacture Patriot air defense systems to counter Russia.

In Kyiv, several explosions were heard shortly after midnight, even before authorities could issue an alert to give civilians time to find shelter.

The early morning Russian attacks killed one woman and injured two others in Kyiv, according to city administration head Tymur Tkachenko. The State Emergency Service said the attack damaged several administrative buildings and warehouses, as well as a garage complex and several trams.

Hours later, another Russian drone struck Kyiv’s Desnianskyi district, killing a second person and injuring six others, Tkachenko said. A total of eight people were injured in the attacks on the capital.

In Kharkiv, two people were killed and 20 others were injured in a series of overnight strikes, according to Mayor Ihor Terekhov.

In Zaporizhzhia, Russian guided bomb injured a man and a woman Tuesday night, regional head Ivan Fedorov said.

Ukraine’s air force says Russia fired 169 long-range strike drones and seven missiles, including five ballistic missiles. Air defenses shot down or jammed 139 drones, and two anti-radar missiles didn’t reach their targets, it said.

All five ballistic missiles and 20 drones struck targets at 15 locations, the air force said, underscoring the continued strain on Ukraine’s air defenses.

Russia’s Defense Ministry said it struck an arms industry facilities in Kyiv, hitting a plant that manufactured components for Flamingo cruise missiles and a facility assembling mid- and long-range drones.

In Ankara, Trump said the U.S. will give a license to Ukraine to manufacture Patriot air defense systems to defend against Russian missile attacks like those that have been striking Kyiv in recent weeks.

It would be a huge coup for Ukraine, which badly needs the systems that are expensive, in high demand and take a long time to produce. Zelenskyy long has been asking for more Patriot systems, as well as the license to produce them.

“We’ll give them the right to make Patriots. We’ll show them how to do it,” Trump said, sitting next to Zelenskyy. “I think they can produce them pretty quickly.”

The tone of their meeting was a markedly different from an earlier, acrimonious encounter at the White House in February 2025 when Trump berated Zelenskyy. On Wednesday, he praised the Ukrainian leader's willingness to reach a deal to ending the war, saying he has “done an amazing job” and “been very effective.”

“We’ve actually developed a good relationship. It’s hard to believe,” Trump said, adding he believed a deal on ending the war was on the horizon and that the U.S. would “work on some kind of security package” for Ukraine.

Zelenskyy thanked Trump for his support and said he wanted to discuss weapons supplies, possible peace negotiations and a developing drone deal.

“Air defense is the priority,” Zelenskyy said, adding that Kyiv wanted to share details of its needs under the Prioritized Ukraine Requirements List, or PURL, in which European allies and Canada are buying American weapons to help his country.

Zelenskyy also said Ukrainian and U.S. officials had begun work on a drone deal, calling it “a very good beginning.”

Trump was expected to have another call with Putin following his meeting with Zelenskyy.

The ministry also said air defenses downed 415 Ukrainian drones from late Tuesday to early Wednesday. Gov. Roman Busargin of Russia's Saratov region said a Ukrainian drone attack killed one person, injured several others and damaged industrial facilities.

Zelenskyy said Ukrainian long-range attacks reached the Saratov, Tatarstan and Bashkortostan regions deep inside Russia, as well as the Voronezh region, closer to the Ukrainian border. The strikes hit refineries in Saratov and Tatarstan, the latest energy facilities struck by Ukraine that have worsened fuel shortages across Russia.

In the Tatarstan region, Nizhhnekamsk Mayor Radmir Belyayev said Ukrainian drones damaged industrial facilities in the city and injured several people. Belyayev didn’t identify the damaged facilities.

Sergei Aksyonov, the Moscow-installed head of the Crimean Peninsula that was illegally annexed by Russia in 2014, said restrictions on civilian fuel sales would continue and that gasoline would not be available “on certain days.”

Aksyonov said many of the decisions being made to resolve the crisis could not be disclosed publicly, adding that he was giving regular updates to Russian President Vladimir Putin.

“The fuel supply situation remains strained and will continue to be so for some time,” he said. “We are monitoring this issue closely in coordination with the federal government and are working on a solution.”

Russia’s Gazprom state-controlled gas company said Ukrainian drones attacked the Krasnodarskaya compressor station serving the Blue Stream natural gas pipeline to Turkey late Tuesday. It said the attack was intended to derail Russian gas shipments to Turkey, but there was no disruption of supplies.

Kremlin spokesman Dmitry Peskov called it another “dangerous” attack against “the critical international energy system” and voiced hope that Turkey and other nations would warn Kyiv against such action.

Rostov regional Gov. Yuri Slyusar said Ukrainian drones damaged two oil tankers in Taganrog Bay, injuring two crew members. The crew of one of the ships had to be evacuated.

He said there was no oil spill because the tankers heading to the port of Rostov-on-Don were empty.

——

Seung Min Kim in Ankara, Turkey, and Michelle L. Price in Washington contributed.

Follow the AP’s coverage of the war in Ukraine at https://apnews.com/hub/russia-ukraine

U.S. President Donald Trump meets with Ukraine's President Volodymyr Zelenskyy on the sidelines of the NATO summit in Ankara, Turkey, Wednesday, July 8, 2026. (AP Photo/Alex Brandon)

U.S. President Donald Trump meets with Ukraine's President Volodymyr Zelenskyy on the sidelines of the NATO summit in Ankara, Turkey, Wednesday, July 8, 2026. (AP Photo/Alex Brandon)

Ukraine's President Volodymyr Zelenskyy, left, arrives for the NATO Summit in Ankara, Turkey, Tuesday, July 7, 2026. (Metin Aktaş, Pool Photo via AP)

Ukraine's President Volodymyr Zelenskyy, left, arrives for the NATO Summit in Ankara, Turkey, Tuesday, July 7, 2026. (Metin Aktaş, Pool Photo via AP)

In this photo provided by the Ukrainian Emergency Service, emergency services personnel work to extinguish a fire following a Russian air attack in Kyiv, Ukraine, Wednesday, July 8, 2026. (Ukrainian Emergency Service via AP)

In this photo provided by the Ukrainian Emergency Service, emergency services personnel work to extinguish a fire following a Russian air attack in Kyiv, Ukraine, Wednesday, July 8, 2026. (Ukrainian Emergency Service via AP)

In this photo provided by the Ukrainian Emergency Service, emergency services personnel work to extinguish a fire following a Russian air attack in Chernihiv, Ukraine, Wednesday, July 8, 2026. (Ukrainian Emergency Service via AP)

In this photo provided by the Ukrainian Emergency Service, emergency services personnel work to extinguish a fire following a Russian air attack in Chernihiv, Ukraine, Wednesday, July 8, 2026. (Ukrainian Emergency Service via AP)

In this photo provided by the Ukrainian Emergency Service, emergency services personnel work to extinguish a fire following a Russian air attack in Kyiv, Ukraine, Wednesday, July 8, 2026. (Ukrainian Emergency Service via AP)

In this photo provided by the Ukrainian Emergency Service, emergency services personnel work to extinguish a fire following a Russian air attack in Kyiv, Ukraine, Wednesday, July 8, 2026. (Ukrainian Emergency Service via AP)

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