FDA clears Viz.ai algorithm for quantifying intracerebral hemmorhage

The Viz ICH Plus algorithm displayed on a smartphone. [Image courtesy of Viz.ai]Viz.ai announced that it received FDA 510(k) clearance for its Viz ICH Plus algorithm for providing volume measurements of brain bleeds.

Viz ICH Plus automates the process of identifying, labeling and quantifying the volume of segmentable brain structures on non-contrast computed tomography (NCCT) images. The company designed it to analyze intracranial hyperdensities, lateral ventricles and midline shifts. These metrics help to enable timely and informed brain bleed treatment decisions.

San Francisco-based Viz.ai developed the algorithm for quantifying intracerebral hemorrhage. This type of hemorrhage accounts for up to 15% of all strokes, the company says, with high morbidity and mortality rates. It requires a swift response with accurate brain bleed measurements to assess the severity of cases and monitor progression.

Radiologists, neurologists and neurosurgeons can incorporat…

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FDA grants de novo nod to hypertrophic cardiomyopathy AI algorithm from Viz.ai

Viz.ai announced today that the FDA granted de novo approval to its Viz HCM module for detecting hypertrophic cardiomyopathy.

San Francisco-based Viz.ai says this creates a new regulatory category for cardiovascular machine learning-based notification software. The company supports its algorithm’s deployment through a multi-year agreement with Bristol Myers Squibb. They struck that partnership deal in March of this year.

With Viz HCM — integrated into the Viz.ai platform — providers can identify more patients with suspected HCM earlier using AI. They can then receive triage and diagnosis for further evaluation.

The Viz HCM module automatically reviews routine electrocardiograms (ECGs) from across a health system. It identifies suspected HCM cases and notifies the appropriate cardiologists and care team on the Viz mobile application. Clinicians can then easily review the patient’s ECG and coordinate follow-up for diagnosis. They can then use t…

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FDA clears Viz.ai algorithm that detects abdominal aortic aneurysm

The Viz AAA solution for detecting and triaging abdominal aortic aneurysm. [Image courtesy of Viz.ai]Viz.ai announced today that it received FDA 510(k) clearance for its algorithm that detects suspected abdominal aortic aneurysm (AAA).

The company said in a news release that this marks the first FDA-cleared, AI-powered solution for detecting and triaging suspected AAA.

Viz.ai’s AI algorithm automatically searches for the presence of an abdominal aortic aneurysm from any computed tomography angiography (CTA) scan. These chest cans can come from any scanner within a hospital network. Viz.ai said this algorithm comprises part of its Viz Aortic Module. The company designed this AI solution to accelerate treatment decisions for all aortic pathology.

Dr. Philip Batista, associated program director of vascular and endovascular surgery residency at Cooper, said the majority of AAA patients are asymptomatic. Many remain unaware of their disease until a rupture…

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Viz.ai partners with Bristol Myers Squibb on early hypertrophic cardiomyopathy detection

Viz.ai announced today that it entered into a multi-year agreement with Bristol Myers Squibb (NYSE:BMY) for detecting hypertrophic cardiomyopathy.

The partnership seeks to deploy an AI algorithm and the Viz HCM provider workflow software. This can help identify and triage patients who may require further evaluation for the detection of hypertrophic cardiomyopathy.

San Francisco-based Viz.ai submitted a de novo request to the FDA for the algorithm as a software-as-a-medical device (SaMD). The agency accepted the filing for review, according to a news release.

Hypertrophic cardiomyopathy (HCM) occurs when heart muscle thickens, making it harder for the heart to pump blood. It can lead to increased risks of AFib, mitral valve disease and heart failure.

Suhas Krishna, Bristol Myers Squibb VP and head of digital health product management, said the company believes AI can positively impact patients’ lives by detecting key, subtle characteristics i…

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Viz.ai launches AI-powered vascular suite

The Viz.ai Vascular Suite. [Image courtesy of Viz.ai]Viz.ai announced that it launched its Viz Vascular Suite for detecting and triaging care for a range of suspected vascular conditions.

Those conditions include pulmonary embolism, right heart strain, aortic dissection and abdominal aortic aneurysm (AAA).

San Francisco-based Viz.ai submitted a 510(k) application to the FDA for the AI-powered software, according to a news release.

Viz.ai CEO Chris Mansi said the platform helps clinical teams “achieve better clinical outcomes.” He touted positive feedback from early adopters and said the company plans to expand access to the suite. Viz.ai currently has a hospital customer base totaling more than 1,300.

“We set out to build a solution where any patient with life-threatening diseases can benefit from AI-powered care coordination with triage and real-time mobile communication,” said Mansi.

The Viz Vascular Suite uses AI to automa…

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Viz.ai launches AI-powered radiology suite

Viz.ai announced today that it launched an AI-powered radiology suite for alerting radiologists and connecting care teams in real-time.

San Francisco-based Viz.ai designed the suite to alert radiologists in their workflow of suspected diseases. It also prioritizes worklists and connects care teams while integrating into picture archiving and communications systems (PACS). This helps to securely facilitate access to imaging data across departments while streamlining patient diagnosis.

“With an increasing demand for imaging studies and a global shortage of radiologists, technologies that can be easily integrated into radiology workflows to enhance efficiency and streamline patient care are sorely needed,” said Dr. Allan Brook, director of interventional neuroradiology at Montefiore Medical Center and professor of radiology and neurosurgery at Albert Einstein College of Medicine. “The Viz Radiology Suite offers radiologists important capabilities for optimizing im…

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Viz.ai names Jieun Choe as chief marketing officer

Jieun Choe, Viz.ai chief marketing officer [Photo courtesy of Viz.ai]Viz.ai this week announced it appointed Jieun Choe as chief marketing officer.

Choe will report directly to CEO Chris Mansi and will oversee the global marketing strategy, brand and communications, product marketing and demand generation for the San Francisco-based company.

“Jieun’s deep experience and proven track record in driving growth with expert execution will be invaluable as we continue to expand our footprint worldwide,” Mansi said in a news release. “The addition of her customer-centric approach and strategic, growth mindset to our c-suite will help propel Viz.ai into new frontiers.”

Choe was most recently chief strategy and marketing officer at Certara where she led the global marketing team and drove the strategic planning process. She was an integral part of the company’s successful IPO in December 2020. She has also held leadership roles at Guidant and Boston Scientific…

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FDA clears new Viz.ai algorithm for measuring ventricles in identifying pulmonary embolism

[Image from Viz.ai]Viz.ai announced today that it received FDA 510(k) clearance for its automated RV/LV ratio algorithm as part of the Viz PE solution.

San Francisco-based Viz.ai designed its algorithm to quickly and accurately measure the diameter of the ventricles of the heart. The measurements provide the ratio of the maximum right ventricle (RV) diameter versus left ventricle (LV). Automating this risk indicator for pulmonary embolism (PE) enables care teams to respond quickly.

Viz.ai launched Viz PE in November 2021. It uses deep learning to identify suspected central and segmental pulmonary emboli in under two minutes. The integration of the new RV/LV algorithm adds an automated assessment of potential right ventricle dilation.

The company that this enables care teams make the right decision at the right time. No matter where the patient resides in the healthcare system, this ensures quick and appropriate care, Viz.ai said.

“The Viz.ai automate…

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FDA clears Viz.ai’s algorithm that detects subdural hemorrhage

Viz.ai announced today that it received FDA 510(k) clearance for its Viz Subdural (SDH) artificial intelligence (AI) algorithm.

San Francisco-based Viz.ai designed its Viz SDH algorithm to use AI to automatically detect subdural hemorrhage, enabling physicians to triage patients effectively and deliver optimal care.

The company said in a news release that its Viz SDH represents the only SDH-specific, AI-powered detection and care coordination platform with the ability to identify acute and chronic subdural bleeds, then quickly notify the care team to mobilize in case an immediate intervention is necessary.

“Viz SDH allows us to detect both acute and chronic subdural hemorrhages to better identify early treatment pathways. Acute subdurals require urgent intervention. Therefore, prompt notification will allow us to improve outcomes in emergent cases. Chronic subdurals have a very different pathway and having an algorithm that identifies both can allow us t…

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Viz.ai, Hyperfine partner on new MRI, workflow paradigm

Viz.ai announced today that it partnered with Hyperfine (Nasdaq:HYPR) to bring magnetic resonance imaging (MRI) to the patient’s bedside.

San Francisco-based Viz.ai develops the Viz LVO, its flagship product designed to leverage advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat the patient.

Hyperfine develops Swoop, which it said is the world’s first MR imaging system capable of providing neuroimaging at the point of care, expanding patient access to MRI by bringing imaging to the bedside. Swoop offers a way for physicians to make quick and informed clinical decisions for patients, eliminating hours of wait and transport time, reducing the potential for adverse events associated with transporting critically ill patients.

According to a news release, the partnership and subsequent implementation into neuro ICUs provide the potential to further decrease th…

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Viz.ai raises $100M Series D

Artificial intelligence-based disease detection technology company Viz.ai announced today that it raised $100 million in a Series D financing round.

San Francisco-based Viz.ai develops AI algorithms that detect disease and offer hospital systems a way to ensure that, once detected, the patients are captured and workflows across an entire health system are standardized. The latest algorithm for detecting suspected cerebral aneurysms received FDA clearance in February.

According to a news release, the financing round comes on the back of the company reaching the milestone of more than 1,000 hospitals using the Viz Platform.

Tiger Global and Insight Partners led the financing round, while a number of early backers, including Scale Ventures, Kleiner Perkins, Threshold, GV (formerly Google Ventures), Sozo Ventures, CRV and Susa participated.

Viz.ai said in the release that the new funds will be used to support its growth trajectory as it seeks to expan…

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FDA clears AI algorithm from Viz.ai for detecting cerebral aneurysms

Viz.ai announced today that it received FDA 510(k) clearance for its Viz Aneurysm algorithm for detecting suspected cerebral aneurysms.

San Francisco-based Viz.ai’s new algorithm uses artificial intelligence (AI) to detect the aneurysms, offering hospital systems a way to ensure that, once detected, the patients are captured and the aneurysm workflow across an entire health system is standardized.

According to a news release, the standardized workflow allows for appropriate follow-up care and significant financial benefits for hospital systems and payers. The company touts Viz Aneurysm as a first-of-its-kind population health tool for facilitating population screening and enhanced care management.

The company touted a University of Toronto study that tested the accuracy of the Viz Aneurysm platform using 528 CTAs with 674 aneurysms broadly distributed across the cerebral vascular territories. Analysis demonstrated 94% accuracy using the algorithm.<…

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