MedTech Dive

REDWOOD CITY, Calif. — More than 2,500 physicians have prescribed Osteoboost to date, the first FDA-cleared prescription wearable empowering women to proactively protect and preserve their bone density and bone strength Osteoboost Health, Inc., today announced it has closed an $8 million financing round to scale manufacturing, expand clinical research, and broaden the commercial reach of the company’s FDA-cleared medical device for low bone density.

In sterile barrier packaging, failure rarely announces itself clearly. It appears as an intermittent tear instead of a clean peel, a failed pressure test that cannot be consistently replicated or a seal that seems strong but behaves unpredictably under stress. Consider the following real-world example:  a device requiring a controlled adhesive peel from a small sealing flange (~1mm) on a cylindrical cavity began failing during release testing.

NEW YORK — ACTO, uniting human intelligence with empathetic AI in Life Sciences, today announced the launch of SuperAgents, an industry-first AI innovation designed to orchestrate work for Life Sciences customer-facing professionals. Unlike traditional AI tools that focus on isolated tasks and workflows, ACTO SuperAgents are purpose-built around the workforce—empowering individuals in their roles with intelligent, contextual, and compliant support.

This audio is auto-generated. Please let us know if you have feedback. Endovascular Engineering has raised $80 million to bring to market its mechanical thrombectomy platform to treat pulmonary embolism. The new financing will help E2 scale up its commercial organization while continuing to invest in R&D and operations, the company said Tuesday.

This audio is auto-generated. Please let us know if you have feedback. One year after President Donald Trump’s “Liberation Day” declaration in a White House Rose Garden ceremony unleashed a tariff policy targeting top U.S. trading partners, medtech companies are still absorbing the shocks.

SAN JOSE, Calif. — MEDvidi, an AI-powered mental health company, launches its AI Prescribing Assistant, whichhelps clinicians across the US manage routine medication renewals for patients with ADHD, anxiety, and depression. While the system automates workflow, all prescribing decisions remain under the control of licensed physicians.

This audio is auto-generated. Please let us know if you have feedback. Johnson & Johnson said Tuesday it is introducing the Varipulse Pro pulsed field ablation device in Europe, where it has received CE mark approval. The atrial fibrillation treatment has a lower temperature profile compared to the current version of Varipulse and competitive devices, J&J said. Ablation is five times faster than the previous Varipulse sequence, while achieving equivalent lesions, according to the company.

This audio is auto-generated. Please let us know if you have feedback. VDyne said the Food and Drug Administration approved an investigational device exemption for a pivotal clinical trial of its transcatheter tricuspid valve replacement system. The approval, announced last week, moves VDyne a step closer to competing with Edwards Lifesciences’ Evoque tricuspid valve replacement device.

This audio is auto-generated. Please let us know if you have feedback. Restore Robotics, a company that remanufactures robotic surgical instruments, has received 510(k) clearance from the Food and Drug Administration for two additional Intuitive Surgical da Vinci Xi instruments, the company said this week. The instruments that won new clearances are the da Vinci Xi permanent cautery hook and permanent cautery spatula, Restore CEO Clif Parker told MedTech Dive in an email.

HOUSTON — Prana Surgical, a Houston-based medical device company, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for the Prana System™, an electrosurgical device indicated to remove tissue and control bleeding. The Prana System is a sterile, single-use electrosurgical tool designed for use with standard generators, enabling physicians to localize and excise tissue in a controlled, minimally invasive manner.