DePuy Synthes, the orthopedic device business of Johnson & Johnson , has won FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system. The company said it designed the TriLeap system to address the intricate needs of orthopedic surgeons and foot and ankle specialists. As conditions like bunions become more prevalent —with Cleveland Clinic […]
Johnson & Johnson
FDA issues warning letter to J&J’s Abiomed over Impella heart pump problems
Abiomed, a Johnson & Johnson unit, has received an FDA warning letter related to its Class I recall of Impella heart pumps. The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting […]
J&J’s DePuy Synthes wins FDA clearance for TriAltis tech
Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling […]
Biosense Webster: Catheter ablation leads to lower heart failure risk in AFib patients
Johnson & Johnson’s Biosense Webster today announced data supporting the use of catheter ablation in AFib patients. The study, funded by the Irvine, California-based company, looked at heart failure incidence risks in AFib patients. It compared the use of catheter ablation versus antiarrhythmic drugs (AAD). Looking at non-specific catheter claims information, it showed catheter ablation’s […]
Biosense Webster begins Omnypulse pulsed-field ablation trial
Johnson & Johnson’s Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial. The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures. Dr. Dr. Mattias Duytschaever performed […]
Johnson & Johnson drops 136-year old logo and renames Janssen
Johnson & Johnson has rebranded with a new logo and a new name for its Janssen pharmaceutical business one year after renaming its medical device business — and just weeks after spinning off its consumer health business. New Brunswick, New Jersey–based Johnson & Johnson (NYSE: JNJ) has replaced its 136-year-old logo — based on the signature […]
What are the largest medical device companies?
Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies. However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, […]
Johnson & Johnson finalizes Kenvue spilt-off
Johnson & Johnson announced today that it completed the separation of its Kenvue consumer health business. Kenvue completed its IPO in May 2023. Johnson & Johnson last month announced its intention to split off at least 80.1% of the shares of Kenvue. The separation enables the company to sharpen its focus on its MedTech and […]
FDA deems latest Abiomed Impella recall Class I
Abiomed, a Johnson & Johnson unit, issued another recall for some of its Impella heart pumps. This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge […]
The biggest medtech personnel moves so far in 2023
More than halfway through 2023, we’ve seen plenty of movement in the personnel department across medtech. Last July, we broke down the biggest personnel moves in medtech so far in 2022. That was followed up by the full-year report in December. Through more than eight months, the changes atop medtech companies continue to arrive. Some […]
The 10 largest orthopedic device companies in the world
Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year. Stryker and Zimmer Biomet both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic. GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 […]