Johnson & Johnson MedTech Archives - Page 2 of 7

January 2024 edition: The Leadership in Medtech issue

Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

How Recor Medical won the renal denervation race for FDA approval

Medtech’s biggest personnel moves of 2023

Leadership and innovation in medtech

Creativity, energy, agility — those are three words Recor Medical CEO Lara Barghout used to describe the culture at the world’s first device developer to win FDA approval for hypertension-treating renal denervation (RDN).

You can add persistence to that list. Ever since its founding in 2009, Recor Medical and its team has been pushing to deliver a safe and effective RDN system. The seemingly long odds got longer as larger competitors pulled the plug on their own programs — or in Medtronic’s case, pushed on despite clinical trial failures and won approval shortly after Recor.

Our annual Leadership in Medtech issue of Medical Design &a…

The biggest stories from the 2024 J.P. Morgan Healthcare Conference

Medtronic’s Geoff Martha, Dexcom’s Kevin Sayer and J&J’s Joaquin Duato spoke at this year’s J.P. Morgan Healthcare Conference.

Some of the biggest names in medtech came together this week at the J.P. Morgan Healthcare Conference. They shared updates on financial progress, operational changes and new products, among other things.

Medtronic shared details on plans to restore earnings power, while Abbott highlighted the success of its FreeStyle Libre system. Shockwave Medical outlined its plans for growth, while Dexom

Here are some of the biggest stories to come out of this year’s edition of the J.P. Morgan Healthcare Conference.

Medtronic focuses on earnings power while shifting operational setup

Medtronic Chair and CEO Geoff Martha’s presentation centered on profits for the medtech giant.

“Our top priority is restoring our earnings power — full stop,” he said. “We continue to be this mission-driven company th…

The most important medtech leadership changes of 2023

Former Johnson & Johnson EVP and MedTech Worldwide Chair Ashley McEvoy [Photo courtesy of Johnson & Johnson]

From hirings and firings to promotions, resignations and surprising shake-ups, these were the most important medtech leadership changes of the year.

By Associate Editor Sean Whooley and Managing Editor Jim Hammerand

The leadership change at Johnson & Johnson MedTech was a surprising shift that ended up as the year’s biggest medtech leadership change of 2023.

In October, J&J EVP and J&J MedTech Worldwide Chair Ashley McEvoy announced her resignation from the world’s second-largest device manufacturer. She’s staying on into the first quarter of 2024 while her successor, Tim Schmid, gets settled into his new role.

Schmid, a 30-year J&J vet who was most recently company group chair of J&J MedTech Asia Pacific, said he’s “committed to building ev…

Megadyne Medical recall of patient return electrodes is Class I

The Mega Soft Universal patient return electrode. [Image from Megadyne Medical]The FDA deemed a recall of some Megadyne Medical patient return electrodes, manufactured by J&J’s Ethicon, as Class I, the most serious kind.

This action is a correction, not a product removal.

Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. 8, with the action affecting 9,428 devices distributed between Oct. 1, 2021, and Dec. 4, 2023.

The company initiated this recall to update the instructions for use and product labeling. It seeks to restrict device use to patients 12 years and older. Megadyne received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries could lead to extended hospital stays, scarring and additional surgeries.

Severe burns could lead to potentially long-lasting impacts on patients, especial…

Biosense Webster wins Japanese approval for Varipulse pulsed field ablation

The Varipulse pulsed field ablation system. [Image courtesy of Biosense Webster]Johnson & Johnson MedTech’s Biosense Webster today announced Japanese approval for its Varipulse platform for treating AFib.

Varipulse treats symptomatic drug-refractory recurrent paroxysmal AFib using pulsed field ablation (PFA). The platform features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system.

Biosense Webster says this marks the first and only PFA system approval in Japan.

According to a news release, Varipulse is the first and only Carto-integrated PFA system. It enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

Biosense Webster’s inspIRE trial’s early clinical results demonstrated a one-year clinical success of 78.9% with Varipulse. The trial defined success as freedom from documented symptomatic atrial arrhyt…

J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system

The Aera system. [Image from J&J/Acclarent]Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system.

While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle that expands the patient population for its Aera system.

The new FDA clearance expands access to children aged eight to 17 with persistent obstructive Eustachian tube dysfunction (OETD). Previously only indicated for adults, the system can now treat pediatric patients, making Acclarent the first and only company to achieve a pediatric indication for a Eustachian tube balloon dilation system, according to a news release.

Until now, according to Acclarent, children with persistent OETD only had a handful of options. Those included tympanostomy (ear) tubes, adenoidectomy (rem…

The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

Cerenovus President Mark Dickinson on the future of stroke care

Cerenovus President Mark Dickinson forecasts the innovative technologies that will advance stroke care in the coming years.

Cerenovus Worldwide President Mark Dickinson [Photo courtesy of Johnson & Johnson MedTech]

It’s getting harder to beat aspiration systems for fast and simple thrombectomies to remove blood clots that are blocking oxygen from a stroke patient’s brain.

That’s according to Cerenovus Worldwide President Mark Dickinson, who discussed the future of stroke care in an interview with Medical Design & Outsourcing.

“It’s a very simple concept that the larger the tube you can get to face the blood clot, the more likely you’re going to be able to evacuate that clot just through suction,” he said. “And advances in technology have enabled us — and, candidly, others in the marketplace — to be able to design these larger bore, larger sized devi…

J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial

The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter.

Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib.

AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year.

Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texa…

Former J&J MedTech head Ashley McEvoy takes board role at consumer goods giant

Ashley McEvoy [Image courtesy of Procter & Gamble]Less than two months after announcing her departure from Johnson & Johnson MedTech, Ashley McEvoy has taken on a role on the board of Procter & Gamble.

In October, the former EVP and worldwide chair at J&J MedTech announced her intention to leave the world’s second-largest medical device manufacturer. Tim Schmid took over the position from McEvoy, who spent 27 years at J&J. The reason behind her departure was “to pursue new opportunities,” she said.

While the seasoned medtech executive has yet to share any planned C-level moves, she has a new position on the board at a major consumer goods company in Procter & Gamble. Her appointment to the company’s board of directors went into effect on Dec. 12.

Over the course of her time at J&J, McEvoy most recently led the MedTech unit and spearheaded efforts to develop integrated, digitized solutions. She brought the busine…

Integra LifeSciences to buy Johnson & Johnson’s Acclarent and its ENT tech

Integra LifeSciences (Nasdaq: IART) + announced today that it entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech.

Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market. Integra already offers the MicroFrance line of ENT instruments. The company believes that, upon closing, the deal propels it into a position as a leading provider of ENT products and technologies.

Integra agreed to acquire Acclarent for $275 million in cash at closing. The deal also includes an additional $5 million upon the achievement of regulatory milestones.

“This acquisition presents Integra with a rare opportunity to become a key player in the ENT segment. Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives,” said Jan De Witte, pre…

Johnson & Johnson MedTech says new products will fuel growth

Johnson & Johnson (NYSE: JNJ) + considers itself “uniquely positioned to lead the next wave of healthcare innovation.”

Ahead of a meeting with the investment community today, the company outlined its views on where it stands in the medtech and pharmaceutical markets.

New Brunswick, New Jersey-based Johnson & Johnson set long-term financial targets, including at least 3% sales growth in 2025. It expects a 5%-7% compound annual growth rate (CAGR) from 2025 to 2030.

Within the Johnson & Johnson MedTech business, the company anticipates growth through a differentiated pipeline and geographic expansion. It intends to expand in the interventional cardiovascular, robotics and digital spaces.

The company’s recent moves back up that plan. J&J last week acquired left atrial appendage device maker Laminar, adding to its earlier cardiovascular play in the form of the $16.6 billion ac…