Cardiology
Royal Philips has taken a “significant step” in advancing live-data analytics in clinical practice in a new collaboration with US Mass General Brigham. The parties will leverage software platforms to unify EMR, lab and bedside medical devices data.
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.
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.
The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.
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.
The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.
A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.
Jonathan Kamerman, ambulatory monitoring and diagnostics, national sales leader at Philips, discusses leveraging and managing patient data to solve hospital pressure points.
The US FDA has issued its first communication as part of a new pilot program the agency initiated to increase transparency in recalls of high-risk medical devices. The early alerts are meant to minimize the time between the FDA finding out about a potential issue and informing stakeholders.
A Medtronic-funded study will use Tempus’ Next Cardiology platform to identify aortic and mitral heart valve disease patients who are being undertreated.
Oz is widely seen as a gifted health communicator and has device-industry cred, but brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.
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.
The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.
This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.
Patients treated with Abbott’s Esprit BTK system had better results and fewer repeat procedures after two years than a control group, the company announced this week. Abbott vascular leader Jennifer Jones-McMeans spoke with Medtech Insight about what the results could mean for patient care.
This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.