Clockwise from top left: Abbott Esprit BTK, Smith+Nephew Cori Surgical System, Medtronic Symplicity Spyral, Polarean Xenoview HPX System, Edwards Sapien 3, Boston Scientific Farawave [Images courtesy of the companies]
The Galien Foundation recently announced the nominees for its annual “Best Medical Technology” Prix Galien USA awards.
Each year, the Galien Foundation recognizes global innovators in the medical technology, digital health and startup categories. Winners will be announced at the Prix Galien USA Awards Ceremony on Oct. 30.
“These exceptional nominees … exemplify the transformative power of innovation in medical technology, digital health, and entrepreneurship,” said Kenneth Fraizer, chair of the jury of the Prix Galien USA awards committee. “Their groundbreaking work represents the future of healthcare and our shared commitment to improving lives through scientific excellence.”
To qualify, each device must have been FDA-authorized for marketing within the last five years and “demonstrate significant potential to improve human health.” The Galien Foundation said sales data are not considered part of the nominee and voting process.
Below are the nominees for the 2025 Prix Galien USA Awards. (Of the 25 nominees on this year’s list, 15 were nominated in 2024 as well.)
You can read more about the 2024 nominees here, including Butterfly Network’s Butterfly iQ3 handheld ultrasound system, which won last year’s Prix Galien awards.
Here’s more about the newest nominees:
Abbott: Esprit BTK Everolimus Eluting Resorbable Scaffold System
Abbott Esprit BTK [Image courtesy of Abbott]
Esprit BTK is an everolimus-eluting, bioresorbable scaffold for below-the-knee disease in chronic limb-threatening ischemia. Abbott designed it to improve luminal diameter in infrapopliteal lesions. It provides temporary vessel support and drug delivery, then resorbs over time. Abbott’s labeling specifies use for total scaffolding length up to 170 mm and reference vessel diameters from 2.5 mm to 4.0 mm. The system aims to restore blood flow in small tibial vessels where durable patency is difficult. Read more on Abbott’s website >>
What to know: Bioabsorbable polymers for implantable medical devices
Beyond Air: LungFit PH
LungFit PH generates inhaled nitric oxide from room air at the point of care. The system uses the company’s ionizer technology to produce NO without high-pressure cylinders, and it delivers set concentrations into a ventilator circuit. It includes continuous monitoring for nitric oxide, nitrogen dioxide and oxygen, plus safeguards to prevent abrupt interruption. The device is FDA approved to improve oxygenation and reduce the need for ECMO in term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension, when used with ventilatory support and other appropriate agents. Read more on Beyond Air’s website >>
bioMérieux: Biofire Spotfire System and Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel
BioFire Spotfire is a point-of-care PCR platform for syndromic testing. The Spotfire Respiratory/Sore Throat (R/ST) Panel is performed using either a nasopharyngeal swab for respiratory pathogens or a throat swab for sore throat pathogens. It delivers results in about 15 minutes and is CLIA-waived. The R/ST Panel targets up to 15 viral and bacterial organisms in a single test. Read more on bioMérieux’s website >>
BioProtect: BioProtect Balloon Spacer
The BioProtect Balloon Implant System is a biodegradable rectal spacer used during prostate cancer radiotherapy. BioProtect designed it to reduce rectal dose while enabling planned target coverage. The implant is placed in the perirectal space to position the anterior rectal wall away from the prostate temporarily. The system features a blunt, needleless dilator, a fillable balloon that can be adjusted with sterile saline and the ability to reposition before final placement. Get more on BioProtect’s website >>
Boston Scientific: Farapulse Pulsed Field Ablation System
The Farawave catheter, part of the Farapulse pulsed field ablation system. [Image courtesy of Boston Scientific]
Farapulse delivers non-thermal cardiac ablation using short electrical pulses to create irreversible electroporation of atrial tissue. The company designed the technology to minimize collateral damage seen with thermal energy systems, while also maintaining durable pulmonary vein isolation. The Farapulse platform includes the Farastar generator, Farawave catheters and integrated mapping options, with workflow tools from transseptal access to ablation. Read more about Farapulse on Boston Scientific’s website >>
First Look: Boston Scientific’s next-gen Faraflex PFA and mapping catheter
Cresilon: Traumagel
Traumagel is a plant-based hemostatic gel for temporary external control of moderate to severe bleeding. The single-use, sterile, prefilled syringe delivers a viscous polymer gel that adheres to the wound, forms a mechanical barrier and allows the body to create a natural clot. According to Cresilon, Traumagel is cleared for use by licensed medical professionals in the U.S. and is intended for point-of-injury through definitive care settings. Read more about Traumagel on Cresilon’s website >>
Establishment Labs: Motiva Flora SmoothSilk Tissue Expander
Motiva Flora is a magnet-free, MR conditional breast tissue expander for two-stage reconstruction. It uses a radio-frequency identification (RFID)-enabled port that can be located with a handheld reader to guide percutaneous saline fills. The expander features the company’s SmoothSilk surface and TrueFixation suture tabs to help stabilize positioning. Flora is indicated for temporary subcutaneous or submuscular implantation to develop tissue coverage, typically for less than six months before implant placement. Get more on Establishment Labs’ website >>
OUR United: TaiChiPro
TaiChiPro is an integrated X- and γ-ray radiation therapy system built as a single machine for single-session ‘simultaneous or sequential boost’ treatment. It uses a dual-core, one-machine architecture aimed at patient-customized radiotherapy and includes AI-powered functions to support clinicians. The platform also supports research into spatiotemporal X/γ-ray radiotherapy. Read more from OUR United >>
Perspectum: CoverScan
CoverScan is a software-as-a-medical device workflow that quantifies tissue characteristics, organ size and selected functional metrics from a single, non-contrast MRI exam. The platform analyzes the heart, liver, lungs, kidneys, pancreas and spleen. It produces standardized, quantitative outputs to support clinical decision-making across multi-organ conditions. Perspectum said it wants to reduce fragmented testing to provide reproducible biomarkers for patient triage, monitoring and research. Read more about CoverScan on the Perspectum website >>
Polarean: Xenoview HPX System
Polarean’s HPX system is the device component that prepares Xenoview (hyperpolarized xenon-129) for inhaled MRI of lung ventilation. The HPX hyperpolarizer uses laser-based polarization and a gas-handling manifold to convert a Xe-129 gas blend into a dose of hyperpolarized xenon. The dose is collected in a single-use delivery bag for a brief breath-hold scan, typically 10–15 seconds. The combination enables ventilation imaging without ionizing radiation. Read more on the Xenoview website >>
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