Johnson & Johnson Archives - Page 3 of 33

Johnson & Johnson’s Ethicon settles more Physiomesh suits

Johnson & Johnson has settled more than 200 cases remaining in a multi-district litigation over hernia mesh made by its Ethicon subsidiary.

U.S. District Court Judge Richard Story in Northern Georgia on Dec. 1 agreed to dismiss the cases with prejudice at the request of lawyers for both sides. The lawyers had informed him that they had compromised and settled all claims between them, including all counterclaims, cross-claims and third-party claims.

There were no additional details about the settlement in the court documents.

In a statement shared by a spokesperson, Ethicon said:

“While we empathize with any patients who experience medical complications from surgery, our company acted appropriately and responsibly in the research, development and marketing of its hernia mesh products which have been used to care for millions of patients around the world for more than 50 years. This settlement is not an admission of liability or wrongdoing…

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…

Johnson & Johnson MedTech enters LAA device space with acquisition of Laminar

Johnson & Johnson MedTech announced today that it completed the acquisition of left atrial appendage (LAA) device maker Laminar.

The deal, which includes a $400 million upfront payment, adds Johnson & Johnson MedTech to the crowded LAA device space. Established devices like Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman already exist within the market. Medtronic threw its hat in the ring with the launch of its Penditure LAA exclusion system this week.

However, unlike these technologies, which exclude or occlude the LAA, Laminar’s aims to completely eliminate it to treat AFib. Rather than use catheter-based devices to plug and occlude the LAA, Laminar’s approach utilizes rotational motion. The company recently received FDA approval to begin a U.S. pivotal study, earmarked to start enrollment in early 2024.

“For the millions of people living with AFib, stroke risk is a major concern. The team at Laminar is driven…

Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study

Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology community. “Now, there are some highly respected physicians who’ve said, ‘This is a failed trial,’” said Dr. Peter Taylor, the Norman Collisson Professor of Musculoskeletal Sciences at the University of Oxford. “I think that’s an incorrect interpretation.”

Johnson & Johnson is also pursuing a host of other autoimmune indications for nipocalimab. The FDA has granted it Fast Track designation for hemolytic disease of the fetus and newborn (HDFN) and orphan drug status for HDFN while EMA granted it orphan medicinal product designation for HDFN.

Breaking down the data from IRIS-RA

Johnson …

Ethicon unveils hemostatic sealing patch in Europe

Johnson & Johnson MedTech’s (NYSE: JNJ) + Ethicon today announced the European approval and introduction of Ethizia, its hemostatic sealing patch.

The adjunctive hemostat solution helps to achieve sustained hemostasis in difficult to control bleeding situations. Ethizia features unique synthetic polymer technology for maximum adaptability. Ethicon said it’s the first and only hemostatic matrix designed to be equally active and efficacious on both sides.

Ethizia offers easy handling in both open and minimally invasive surgery. It’s capable of being stuffed, rolled, pulled apart, trimmed and tailored, Ethicon said in a news release. In 80% of clinical trial patients studied, the patch stopped bleeding in 30 seconds. That averages out to six times faster than the leading fibrin sealant patch, Ethicon said.

The patch received CE mark approval as an adjunctive hemostate for disruptive bleeding on inte…

Johnson & Johnson Monarch surgical robot earns regulatory nod for bronchoscopy in China

The Monarch platform. [Image courtesy of Johnson & Johnson’s Ethicon]Johnson & Johnson MedTech (NYSE: JNJ) + announced that its Monarch platform and Monarch bronchoscope obtained regulatory approval in China.

Approval makes Monarch the first minimally invasive, robotic-assisted technology approved for peripheral lung procedures in China. It’s also the first Johnson & Johnson MedTech robotic-assisted technology to receive approval in China. The regulatory nod also marks the first such milestone for Monarch outside the U.S.

It’s another positive step in the surgical robotics space for the company, which issued an update on its Ottava surgical robot last week.

J&J acquired Monarch when it bought Auris for $3.4 billion in 2019, entering the robotic surgery market. It already held FDA clearance for bronchoscopy and last year picked up clearance for endourological procedures.

The …

DePuy Synthes collab aids in whole-eye, partial-face transplant

The surgery lasted approximately 21 hours and included a team of more than 140 surgeons, nurses, and other healthcare professionals, led by Dr. Eduardo D. Rodriguez. [Image courtesy of Joe Carotta/NYU Langone Staff]With help from J&J’s DePuy Synthes, a team at NYU Langone Health performed the world’s first whole-eye and partial-face transplant.

A 46-year-old military veteran from Arkansas who survived a work-related, high-voltage electrical accident underwent the procedure. He had his entire left eye and a portion of his face transplanted from a single donor.

According to NYU Langone Health, it remains unknown if the patient will ever regain sight. However, the transplanted left eye has shown “remarkable signs of health, including direct blood flow to the retina.” NYU Langone says this opens new possibilities for future advancements in vision therapies and related medical fields.

The hospital said its collaboration with DePuy Syn…

Johnson & Johnson plans to submit Ottava surgical robot for FDA IDE next year

Johnson & Johnson MedTech (NYSE: JNJ) + today outlined its plan to submit its new Ottava surgical robot to the FDA.

The company first shared details on the Ottava surgical robotic platform nearly three years ago. It highlighted the potential for unrivaled flexibility and control compared to the rest of the market. The first look at the surgical robot marked a significant step into the surgical robotic space dominated by Intuitive Surgical over the past two decades. J&J joined the list of companies, both large and small, aiming to take Intuitive on in the soft-tissue robotics arena.

Since that day in November 2020, Johnson & Johnson MedTech has remained quiet on the topic, though. In October 2021, it pushed back the platform’s development timeline by about two years due to multiple factors. J&J initially expected to begin the verification and validation processes for Ottava in 2021. The company planned f…

J&J’s Ethicon unveils AI-powered laparoscopic training tech

Johnson & Johnson MedTech’s (NYSE: JNJ) + Ethicon unit today debuted an AI-powered laparoscopic surgical simulation platform.

The first-of-its-kind device integrates augmented reality, AI-guided assessment and tactile feedback. It aims to enhance the surgical skills and training experiences for general, gynecological and laparoscopic surgeons.

Ethicon debuted the system at the American Association of Gynecological Laparoscopists (AAGL) Global Congress. The company said in a news release that its technology “ushers in a new era in surgical training.” The Ethicon Laparoscopic Skills Training Platform offers a highly portable connected digital learning experience. It features adaptability to the learner’s evolving circumstances and integrates into everyday quality education and training routines.

The platform offers personalized and innovative education to expand reach and deepen knowled…

Biosense Webster has positive data for QDOT Micro ablation catheter

The QDOT Micro catheter. [Image courtesy of Biosense Webster]Johnson & Johnson MedTech’s Biosense Webster today announced new findings supporting the use of its QDOT Micro catheter.

Published in the Journal of Cardiovascular Electrophysiology, the results demonstrate improved AFib control. They also showed relief of symptoms and overall quality of life improvements with QDOT Micro ablation treatment.

The QDOT Micro catheter, a next-generation radiofrequency (RF) ablation catheter, utilizes advanced, high-energy ablation. It offers improved temperature monitoring, optimized irrigation and higher signal resolution. In QMODE+, it enables the delivery of ablation at 90 watts for up to four seconds. Standard QMODE delivers RF ablation using up to 50 watts for up to 60 seconds. The QDOT Micro catheter received CE Mark in 2020 and FDA approval in 2022.

Q-FFICIENCY evaluated the catheter’s safety and 12-month efficacy in patients with paroxysmal AFi…

J&J’s DePuy is laying off 67 workers in Colorado

Johnson & Johnson’s (NYSE: JNJ) + DePuy Spine issued a WARN letter confirming 67 layoffs at a facility in Monument, Colorado.

The company issued the letter pursuant to the Worker Adjustment and Retraining Notification (WARN) Act. It decided to eliminate positions permanently at the facility located at 1101 Synthes Avenue, Monument, Colorado.

DePuy’s letter said the action comes as a result of a business decision. The company elected to permanently discontinue manufacturing, quality and distribution activities at the location. Employee separation comes over the course of a 14-day window. The state received the WARN letter on Oct. 30 and it says layoffs begin on Dec. 29, 2023.

Jobs affected by the layoffs include assembly/packaging, business solutions, facilities and manufacturing/production positions. The largest amount of employees affected — 41 — hold material/handling/distribution jobs. The lay…

Who is Tim Schmid, Johnson & Johnson MedTech’s new leader?

Johnson & Johnson MedTech Worldwide Chair Tim Schmid [Photo courtesy of Johnson & Johnson]Tim Schmid is the new worldwide chair of Johnson & Johnson MedTech and Johnson & Johnson (NYSE: JNJ) + EVP following Ashley McEvoy’s announcement today that she plans to resign from the world’s second-largest medical device manufacturer.

“We are pleased to have the depth of talent at Johnson & Johnson that allows us to transition to Tim, a respected, results-driven and Credo-based leader,” J&J Chair and CEO Joaquin Duato said in a news release.

McEvoy called Schmid “a trusted friend and partner” in a LinkedIn post announcing her resignation.

In a statement, Schmid said he was honored to be appointed to the leadership role.

“Building on my 30-year career at Johnson & Johnson, I look forward to leading our incredible team of associates around the world who are propelling…