The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.
A new study by AcuityMD, presented at AAOS 2025, highlights the continued shift of spinal surgeries to the outpatient setting, with state-by-state variability in ASC adoption. While hospitals still dominate spinal procedures, advancements in minimally invasive techniques and medical technologies are major drivers of spinal surgeries in the ASC setting.
Boston Scientific has entered the multi-billion hypertension treatment market with the acquisition of Israel-based startup SoniVie, developer of the TIVUS intravascular ultrasound system for the treatment of high blood pressure by artery nerve ablation.
Boston Scientific has integrated cardiac mapping and pulsed field ablation into a single catheter with the newly EU-approved Farawave Nav Ablation Catheter. Faraview Software also receives CE marking, allowing for visualization of catheter placement when delivering therapy.
France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.
Volta Medical’s TAILORED-AF clinical trial demonstrates that AI can achieve "superior efficacy" in interventional cardiology. The study examined the use of AI-driven Volta AF-Xplorer in addition to pulmonary vein isolation in treating patient with persistent atrial fibrillation.
While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.
An innovative patient monitoring system developed by Danish physicians sends vital signs data directly to nurses, allowing them to keep tabs on patients without being in the room.
Stryker is selling its $700m spinal implants business to Viscogliosi Brothers, forming a new entity VB Spine, which will maintain a strong partnership with Stryker. The company also reported strong Q4 financials and announced a CFO transition.
During CES 2025, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis to identify the biggest trends in digital health and solutions poised to transform the future of health care. Key trends included empowering consumers with actionable health data, the rising investment in specialized areas such as women’s health, and more companies pursuing regulatory clearance for health products.
Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.
Boston Scientific's Farapulse Pulsed Field Ablation System achieved safety and effectiveness endpoints in the ADVANTAGE AF clinical trial for the treatment of persistent atrial fibrillation, supporting “the paradigm shift to pulse-field ablation,” said Vivek Reddy, director of electrophysiology at Mount Sinai Fuster Heart Hospital.
Boston-area start-up Axoft is developing a soft brain-computer interface device to help coma patients with covert consciousness communicate. Medtech Insight spoke with Axoft’s CEO Paul Le Floch about the technology, plans for first-in-human trials and potential future applications of the device to help patients with disorders of consciousness, including patients in a coma or vegetative state, communicate.
Jerome Trividic, CEO of Swiss company Spineart, believes that by solving pain points felt by orthopedic surgeons performing spinal procedures, it can improve patient outcomes. He thinks the firm’s innovative approach, which focuses on partnership deals as well as developing its own products, will give it a competitive edge in the spinal surgery market.
After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.
Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.
This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.
France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.
The US FDA’s advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.