Visionairy Health Secures CE Marking for its AI-Based X-Ray Triage Tool

Visionairy Health, is a Health-tech AI company. Today they announced they obtained CE Marking for X1, its artificial intelligence (AI) based chest x-ray triage and prioritization product. X1 is a state-of-the-art medical device that uses deep learning to analyze chest x-rays, flagging those images that are suggestive of the presence of one or more of 15 pre-specified findings (including tuberculosis, pneumothorax, and lung nodules).

Visionairy Health notes it has been trained using hundreds of thousands of chest x-rays from dozens of geographical locations. X1 is PACS agnostic and can be easily integrated with existing radiology software. The software’s notifications act as a secondary check in parallel to physicians’ independent assessment to ensure that imaging studies with any prespecified findings are brought to their immediate attention.

“We’re excited to receive CE Marking, as this allows us to deploy X1 in Europe and delve into the other markets in the Middle East, Africa, and Asia as a next step,” says Moustafa Amin, Co-founder and CEO of Visionairy Health.

Visionairy Health has partnerships with large healthcare providers in those regions and they are eager to use X1. Dr. Hesham Zaki, VP of Radiology and Informatics at GNP Hospitals Group, an early partner of VH, says: “At GNP, we process a large number of chest x-rays every day, so we are looking forward to using the X1 triage tool. With X1, our physicians can be more efficient and focus on scans that require their immediate attention.”

X1 is part of a suite of AI products being developed by VH to help clinicians manage the ever-increasing volume of diagnostic radiography in hospitals and clinics around the world. The CE marking of X1 paves the way for its commercial launch in most regions of the world

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”