 |
- First and only contact force pulsed field ablation (PFA) system engineered to revolutionize care for the hundreds of thousands at risk of death from ventricular tachycardia (VT).
- FDA's TAP Pilot and Breakthrough Device Designation are awarded to medical devices that could provide more effective treatment compared to existing approved treatments, reflecting the agency's commitment to expediting patient access to innovative, safe, and effective therapies.
CARDIFF-BY-THE-SEA, Calif., Dec. 5, 2024 /PRNewswire/ -- Field Medical® Inc., a leader in pulsed field cardiac catheter ablation technology, announced today that its FieldForceâ„¢ Ablation System has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot and granted Breakthrough Device Designation for sustained monomorphic scar-related ventricular tachycardia (VT). This recognition underscores the system's groundbreaking approach to addressing life-threatening VT and the critical unmet needs for patients worldwide.
"The FDA's TAP Pilot acceptance and Breakthrough Device Designation for the FieldForceâ„¢ Ablation System represent pivotal milestones in our journey to regulatory approval," said Dr. Steven Mickelsen, CEO of Field Medical. "This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care."
Dr. Vivek Reddy, Director of Electrophysiology at Mount Sinai Health System, added, "The FDA's recognition of this breakthrough technology underscores the urgent need for innovation in treating complex, life-threatening ventricular tachycardia. Field Medical's ablation system has the potential to redefine VT care for physicians and patients alike."
The FieldForceâ„¢ Ablation System is the first and only PFA system specifically designed for ventricular arrhythmia ablation. Catheter ablation has been shown to be superior to medical therapy in patients at risk of sudden cardiac death (SCD) from VT (Sapp et al., 2024). SCD, which accounts for approximately 450,000 deaths annually in the United States alone (Mason et al., 2022) is often attributed to VT. Current pharmacological therapies are limited in efficacy, with 30-50% of patients with VT not responding well to traditional drug treatments (Kircher et al., 2023). The emerging science highlights the pressing need for innovative solutions like the FieldForceâ„¢ Ablation System.
About Field Medical® Inc.
Founded in 2022, Field Medical is advancing next-generation pulsed field ablation (PFA) technologies to address the complex needs of modern cardiac ablation. The company is led by Dr. Steven Mickelsen, a pioneer in pulsed electric field technology and one of the foremost innovators in the field. Dr. Mickelsen's foundational work in PFA established the basis for modern advancements in the technology, which Field Medical continues to refine with its groundbreaking solutions. The company's proprietary FieldBendingâ„¢ technology and comprehensive product portfolio, including the FieldForceâ„¢ Catheter, FieldForceâ„¢ Ablation System, and FieldFlexâ„¢ Sheath, are designed to expand PFA applications beyond atrial fibrillation to treat complex ventricular arrhythmias. Field Medical is committed to advancing patient outcomes through innovation, transforming cardiac care for the millions impacted by these life-threatening conditions worldwide.
About FieldForceâ„¢ Ablation System. The FieldForce Ablation System features a single-point contact force PFA catheter with an innovative design utilizing proprietary FieldBendingâ„¢ technology to deliver targeted, brief, high-intensity electric fields. This next-generation PFA technology was designed to deliver both precise targeted lesions and large volume transmural lesions in the ventricle.
For more information, visit www.fieldmedicalinc.com and follow us on LinkedIn and X.
The FieldForceâ„¢ PFA Ablation System is an investigational device and is limited by Federal (or United States) Law to investigational use.
Media Contact
Holly Windler
619.929.1275
References:
Mason, J., et al. (2022). "Trends in Sudden Cardiac Death Due to Ventricular Tachycardia and Fibrillation in the United States." Circulation Research.
Kircher, A., et al. (2023). "Efficacy of Antiarrhythmic Medications in the Treatment of Ventricular Tachycardia: A Review." Journal of the American College of Cardiology.
Sapp, J., et al. (2024). "Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia." The New England Journal of Medicine. DOI: 10.1056/NEJMoa2409501.
Photo - https://mma.prnasia.com/media2/2574172/Field_Medical_FieldForce_PFA___Full_Thickness_Endocardial_Ablation.jpg?p=medium600
Logo - https://mma.prnasia.com/media2/2574173/Field_Medical_Logo_Block_WhiteOnBlack_Logo.jpg?p=medium600
- First and only contact force pulsed field ablation (PFA) system engineered to revolutionize care for the hundreds of thousands at risk of death from ventricular tachycardia (VT).
- FDA's TAP Pilot and Breakthrough Device Designation are awarded to medical devices that could provide more effective treatment compared to existing approved treatments, reflecting the agency's commitment to expediting patient access to innovative, safe, and effective therapies.
CARDIFF-BY-THE-SEA, Calif., Dec. 5, 2024 /PRNewswire/ -- Field Medical® Inc., a leader in pulsed field cardiac catheter ablation technology, announced today that its FieldForceâ„¢ Ablation System has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot and granted Breakthrough Device Designation for sustained monomorphic scar-related ventricular tachycardia (VT). This recognition underscores the system's groundbreaking approach to addressing life-threatening VT and the critical unmet needs for patients worldwide.
"The FDA's TAP Pilot acceptance and Breakthrough Device Designation for the FieldForceâ„¢ Ablation System represent pivotal milestones in our journey to regulatory approval," said Dr. Steven Mickelsen, CEO of Field Medical. "This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care."
Dr. Vivek Reddy, Director of Electrophysiology at Mount Sinai Health System, added, "The FDA's recognition of this breakthrough technology underscores the urgent need for innovation in treating complex, life-threatening ventricular tachycardia. Field Medical's ablation system has the potential to redefine VT care for physicians and patients alike."
The FieldForceâ„¢ Ablation System is the first and only PFA system specifically designed for ventricular arrhythmia ablation. Catheter ablation has been shown to be superior to medical therapy in patients at risk of sudden cardiac death (SCD) from VT (Sapp et al., 2024). SCD, which accounts for approximately 450,000 deaths annually in the United States alone (Mason et al., 2022) is often attributed to VT. Current pharmacological therapies are limited in efficacy, with 30-50% of patients with VT not responding well to traditional drug treatments (Kircher et al., 2023). The emerging science highlights the pressing need for innovative solutions like the FieldForceâ„¢ Ablation System.
About Field Medical® Inc.
Founded in 2022, Field Medical is advancing next-generation pulsed field ablation (PFA) technologies to address the complex needs of modern cardiac ablation. The company is led by Dr. Steven Mickelsen, a pioneer in pulsed electric field technology and one of the foremost innovators in the field. Dr. Mickelsen's foundational work in PFA established the basis for modern advancements in the technology, which Field Medical continues to refine with its groundbreaking solutions. The company's proprietary FieldBendingâ„¢ technology and comprehensive product portfolio, including the FieldForceâ„¢ Catheter, FieldForceâ„¢ Ablation System, and FieldFlexâ„¢ Sheath, are designed to expand PFA applications beyond atrial fibrillation to treat complex ventricular arrhythmias. Field Medical is committed to advancing patient outcomes through innovation, transforming cardiac care for the millions impacted by these life-threatening conditions worldwide.
About FieldForceâ„¢ Ablation System. The FieldForce Ablation System features a single-point contact force PFA catheter with an innovative design utilizing proprietary FieldBendingâ„¢ technology to deliver targeted, brief, high-intensity electric fields. This next-generation PFA technology was designed to deliver both precise targeted lesions and large volume transmural lesions in the ventricle.
For more information, visit www.fieldmedicalinc.com and follow us on LinkedIn and X.
The FieldForceâ„¢ PFA Ablation System is an investigational device and is limited by Federal (or United States) Law to investigational use.
Media Contact
Holly Windler
619.929.1275
References:
Mason, J., et al. (2022). "Trends in Sudden Cardiac Death Due to Ventricular Tachycardia and Fibrillation in the United States." Circulation Research.
Kircher, A., et al. (2023). "Efficacy of Antiarrhythmic Medications in the Treatment of Ventricular Tachycardia: A Review." Journal of the American College of Cardiology.
Sapp, J., et al. (2024). "Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia." The New England Journal of Medicine. DOI: 10.1056/NEJMoa2409501.
Photo - https://mma.prnasia.com/media2/2574172/Field_Medical_FieldForce_PFA___Full_Thickness_Endocardial_Ablation.jpg?p=medium600
Logo - https://mma.prnasia.com/media2/2574173/Field_Medical_Logo_Block_WhiteOnBlack_Logo.jpg?p=medium600
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Field Medical's FieldForce™ Ablation System Earns FDA TAP Pilot Acceptance and Breakthrough Device Designation for the Treatment of Ventricular Tachycardia.
LAS VEGAS, Jan. 10, 2026 /PRNewswire/ -- The four-day 2026 Consumer Electronics Show (CES 2026) concluded in Las Vegas, with BiLight, a global pioneer in flexible perovskite photovoltaic (PV) technology, making a standout debut as a green tech dark horse. Guided by its brand vision of "Energy Equity," the company is driving the global scenario-based adoption of flexible PV technology.
Themed "Defining the Physical Boundaries of AI," this year's CES highlighted the deep integration of green energy and AI as a key trend. BiLight showcased three core product lines at the Las Vegas Convention Center, shattering the inherent perception of traditional PV products as "bulky, rigid, and single-scenario." Among the highlights, the world-premier rollable flexible perovskite solar curtain garnered significant attention, integrating sunshade, heat insulation, and power generation functions to directly supply electricity to home and office devices, reshaping the "PV + Space" application ecosystem. Additionally, the handheld rollable solar product became a hot favorite for outdoor PV applications, thanks to its portability and efficient energy supplementation capabilities. The lithium-free perovskite electronic nameplate set a new benchmark for office innovation: optimized with low-light power generation technology, it can stably supply energy under ordinary indoor lighting. Paired with low-power e-paper display and Bluetooth refresh functions, it achieves "seamless charging and permanent use," addressing the resource waste of traditional paper nameplates and the environmental concerns of lithium-ion battery devices. This innovative solution attracted extensive consultations and negotiations with office equipment manufacturers and purchasers.
BiLight's tech strength sparked cross-industry collaborations. A top energy storage firm discussed joint R&D for "flexible PV + portable storage" to ease outdoor device battery anxiety. Automotive representative SHM explored rollable solar sunroofs and curtain PV for enhanced vehicle endurance. AI hardware firm BleeqUp and satellite companies also engaged, probing applications in smart terminals, space energy, and IoT tracking.
At a TMTPost-hosted roadshow, BiLight Co-Founder James Fang outlined a three-year roadmap: full-scenario coverage across consumer electronics, automotive storage, building-integrated PV, and satellite energy, building a "PV+" ecosystem. This vision and clear strategy strengthened global partners' confidence.
Looking ahead, BiLight will prioritize R&D, deepen global collaborations, and expand flexible PV's reach. Committed to reshaping the global energy landscape, it aims to fulfill its "Energy Equity" promise—making green energy accessible to all.
CONTACT: Hugo Ni, hugoni@bilight.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
BiLight Dazzles CES 2026: Flexible Perovskite PV Leads Green Tech Wave, Forges Global Partnerships