HRS Released Framework For Afib Center Of Excellence To Improve Outcomes Through Multidisciplinary Care

 
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Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

Looking Back Towards The Future

 

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

J&J Medtech’s FDA-Cleared DUALTO System Prepares For Future Use With OTTAVA Robotic Platform

 
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DUALTO’s double-module option provides enhanced flexibility while cutting down on equipment clutter. Compared to traditional setups, the system reduces OR footprint by 46%, helping staff reclaim space and optimize surgical workflows.


Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

LSI 2025: Egg Medical Builds ‘Nests’ Around Interventional Cardiologists To Protect Against Scatter Radiation

 
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Egg Medical is ramping up efforts to expand international sales of its EggNest scatter radiation protection system to shield X-ray procedure room staff without disrupting workflow. Medtech Insight sat down with Bob Wilson, Egg Medical’s CEO, to discuss the various EggNest systems, marketing opportunities and the competitive landscape.

Enovis Appoints Damien McDonald CEO, Reaffirms Q1 Guidance Amid Strategic Growth Push

 
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Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.

Digital Health Roundup: Intuitive Surgical CEO Exec Chat, AI Alert System, FDA, Roche New NGS Prototype

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her conference coverage from CES, HIMSS, AAOS and LSI including Exec Chats with Gary Guthart, CEO of Intuitive Surgical, and Arcadia’s chief strategy officer Aneesh Chopra. Brian Bossetta highlights a recently FDA-cleared alert system that sends vital signs to clinicians. Elizabeth Orr discusses FDA warning letters sent to Exer Labs for exceeding marketing claims under what is allowed under the device’s 510(k) clearance. Shubham Singh discusses how Roche's unveiling of its next-generation sequencing (NGS) prototype challenges Illumina. The SBX technology is set to compete directly with Illumina’s NovaSeq and NextSeq platforms.


LSI 2025: Vektor Medical CEO Says ‘Arrhythmia Is The Biggest Health Care Crisis Nobody Talks About,’ vMap Treats It With 91.1% Accuracy

 
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Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.

LSI 2025: Intuitive Surgical CEO Gary Guthart On da Vinci 5’s Force Feedback, Digital Coaching, ION Expansion, And Robotic Surgery’s Future

 
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Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.

One Death Linked To Calyxo Urological System

 

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.

AAOS 2025: AcuityMD Study Finds Innovation Continues To Drive Outpatient Spinal Procedures

 
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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 Targets Multi-Billion Hypertension Market With SoniVie Acquisition

 

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 Sets ‘New Clinical Innovation Standard’ For Pulsed Field 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.

‘Profitability On The Horizon’ For UV-C Disinfection Solution Company Germitec

 

France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.

More Patients Free From Atrial Fibrillation With AI-Guided Pulmonary Vein Isolation Treatment

 

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.


BD Catheter For Removing Arterial Plaque Linked To Deaths In FDA Early Alert

 

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.

AI-Powered Patient Alert System Can Save Time, And Lives

 

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.

Analysts Call Stryker’s Spinal Implant Business Spin Off To Viscogliosi Brothers ‘Smart Spine Deal’

 
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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.

CES 2025: Scouting Digital Health Floor With Deloitte Analysts To Discover Emerging Trends

 
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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.