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Johnson & Johnson MedTech Temporarily Pauses U.S. Varipulse Cases

Johnson & Johnson MedTech has announced a temporary pause on all U.S. cases using its Varipulse pulsed field ablation (PFA) system starting January 5, as it investigates the root cause of four reported issues.

Johnson & Johnson MedTech has announced a temporary pause on all U.S. cases using its Varipulse pulsed field ablation (PFA) system as of January 5. The decision was made out of an abundance of caution while the company investigates the root cause of four reported issues. This pause affects the U.S. External Evaluation and all U.S. Varipulse cases.
In other medical device news, AerWave has completed the first-in-human feasibility study of its disease-modifying ultrasound lung denervation therapy, aimed at treating chronic obstructive pulmonary disease (COPD) and asthma. The New York-based company also raised $12 million to further advance this therapy.
Karl Storz has acquired the medical business of T1V, a visual collaboration software company, marking a significant step towards shaping integrated hardware and software for digital surgery.
Kuros Biosciences USA has entered into a strategic five-year, exclusive sales agency agreement with Medtronic to advance the adoption of its MagnetOs bone graft technologies.
Zeto closed a $31 million funding round to support its AI-driven EEG brain monitoring technology, with plans to expand its commercial and operational teams.
Boston Scientific agreed to acquire Bolt Medical, the developer of an intravascular lithotripsy (IVL) platform, in a deal valued at $600 million upfront, with up to an additional $300 million upon achieving certain regulatory milestones.
Lifeward (formerly ReWalk Robotics) announced an agreement to sell ordinary shares for proceeds of $5 million, issuing more than 1.8 million shares priced at $2.75 apiece.
Fire1 completed a $120 million financing round to accelerate the advancement of its heart failure management system, also reaching a major FDA milestone with breakthrough device designation.
Francis Medical completed an oversubscribed $80 million Series C equity financing, with plans to develop its proprietary water vapor technology.
CeQur, an insulin delivery technology developer, closed a $120 million financing round to support its commercialization efforts.
Xeltis completed enrollment in an EU pivotal trial for aXess, its restorative vascular access conduit, evaluating its use in adults with end-stage renal disease.
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Reference News

[1]
Latest Medical Device News on MassDevice
massdevice.com · Jan 10, 2025

Johnson & Johnson MedTech paused U.S. Varipulse cases for investigation. AerWave completed a lung denervation study and ...

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