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milla1cf Fri, 09/08/2023 - 16:25 September 8, 2023 — Positron Corporation , a leading molecular imaging medicaldevice company, is pleased to announce that the Company will begin its clinical study of its Affinity PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA. on September 18, 2023.
In silico imaging trials represent a viable source of regulatory evidence for imaging device evaluation, according to an analysis conducted by the U.S. Food and Drug Administration (FDA) and published August 9 in Plos Computational Biology. Read the full paper here.
Commercial AI devices that lack adequate clinical validation may pose risks for patient care – and unfortunately, that’s true for almost half of the tools cleared so far by the U.S. Most notably, 226 of 521 (43%) lacked published clinical validation data.
mtaschetta-millane Wed, 07/17/2024 - 10:52 July 17, 2024 — Hyperfine , a groundbreaking medicaldevice company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system—announced the clearance of the ninth generation of AI-powered Swoop system software.
milla1cf Fri, 01/26/2024 - 21:11 January 26, 2024 — InkSpace Imaging , a leader in innovative diagnostic medicaldevice technology, is proud to announce it received FDA clearance for its next-generation Small Body Array for the Siemens Healthineers Magnetom Skyra and Vida series 3T MRI scanners.
MD, issued a nine-page letter to Congress recommending how to solve the reimbursement problem for AI in healthcare and ensure clinical AI is of value to patients and health systems. American College of Radiology (ACR) CEO William Thorwarth Jr.,
Simply put, we cannot use large language models as a medicaldevice,” Cozzi told AuntMinnie.com. The researchers also assessed the impact of discordant category assignments on clinical management. Frequency of BI-RADS category changes in clinical management of breast imaging findings Finding Human readers Gemini GPT-3.5
Researchers led by Seyed Tabatabaei, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, in their clinical perspective outlined these pitfalls and made suggestions on AI model training and validation, as well as using diverse datasets.
Positron’s new Attrius customer will take advantage of the Company’s Lease to Own Program which provides a complete package of an Attrius PET System and the full scope Clinical & Technical Services for one monthly price.
The research combined AppliedVR's RelieVRx medicaldevice with Kernel Flow and FlowVR, a compact TD-fNIRS brain measurement headset customized for use in VR to measure brain hemodynamic changes tied to pain relief. Additionally, those receiving treatment from the RelieVRx device achieved a slower breathing rate.
milla1cf Fri, 03/15/2024 - 16:41 March 15, 2024 — Visitors to the Philips Booth at HIMSS in Orlando, Fla, experienced smart, scalable and sustainable clinical solutions designed to help accelerate speed to diagnosis and treatment while improving operational efficiencies, patient outcomes, health equity, and staff experience.
CPIC has begun its work by weighing in on 2024 final payment rules, engaging with stakeholders in the cardiac community, and developing a 2024 policy agenda.
As a world leader monitoring more than 600 million patients each year worldwide, Philips is creating an open patient monitoring ecosystem to bring together disparate medicaldevices and systems on a single interface. Every day, clinicians make countless care decisions based on information from divided medicaldevices and systems.
The companies are partnering to further enable the Polarean xenon 129 MRI platform to accelerate clinical and research use. These new products and services will be utilised to expand access to xenon 129 MRI as a lung imaging service and to investigate new indications and biomarkers in broader populations with unmet medical needs.
milla1cf Thu, 03/07/2024 - 20:10 March 7, 2024 — GE HealthCare will showcase its industry-leading portfolio of artificial intelligence ( AI )-enabled medicaldevices and digital solutions in Booth 2500 at the Health Information and Management Systems Society ( HIMSS ) Global Health Conference and Exhibition in Orlando, FL from March 11-15, 2024.
CQ Medical marks a pivotal transformation for CIVCO Radiotherapy and Qfix, who joined forces in October 2022. Under its new mantra, Care Smarter , CQ Medical will seek to expand on the company's history of innovative clinical solutions, unmatched product depth and breadth, and a passion for customer and patient care.
Expanded Scanning Scope: The PCD scanning capabilities now cover a full 30cm field of view, ensuring comprehensive imaging potential for a variety of clinical applications. Enhanced Operating Environment: The operating environment ambient temperature has been increased, broadening the range of conditions in which the device can be used.
The SDK can be leveraged by artificial intelligence ( AI ) software developers, medicaldevice companies building ultrasound into their platforms, and telemedicine companies adding ultrasound into their virtual care workflows.
a groundbreaking medicaldevice company that has redefined brain imaging with the world’s first FDA -cleared portable magnetic resonance brain imaging system—the Swoop system—announced FDA clearance of updated software. We believe in making brain imaging more accessible, clinically relevant, and actionable.
Expanded Scanning Scope: The PCD scanning capabilities now cover a full 30cm field of view, ensuring comprehensive imaging potential for a variety of clinical applications. Enhanced Operating Environment: The operating environment ambient temperature has been increased, broadening the range of conditions in which the device can be used.
mtaschetta-millane Thu, 07/25/2024 - 08:28 July 25, 2024 — Positron Corporation , a leading molecular imaging medicaldevice company offering PET & PET-CT imaging systems, presents its new NeuSight PET-CT 3D 64 slice scanner, available for US and North American Markets.
With strong demand for medical imaging in many differing clinical contexts, hospitals are managing growing routine imaging demands while balancing teaching practices, ambulatory services, primary care, and subspecialty services. billion healthcare facility. Another, a new hospital complex is underway at University of Utah Health.
milla1cf Thu, 06/13/2024 - 20:46 June 13, 2024 — Positron Corporation , a leading molecular imaging medicaldevice company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical support services, announced it has entered an agreement to acquire the FDA 510(k) for the NeuSight PET-CT from its cooperative (..)
Compared to conventional scanners, the O-scan has a compact footprint that can fit into almost any clinical setting and a comfortable, open-concept design that is ideal for scanning children and claustrophobic patients," says Stephen Gibbs , Marketing and Sales Manager at Esaote North America, Inc.
christine.book Tue, 10/03/2023 - 11:37 October 3, 2023 — Medicaldevice company GT Medical Technologies, Inc. We could not have achieved these interim clinical results without the support of the doctors and patients who were part of this registry study from across the nation," said Brachman.
mtaschetta-millane Tue, 07/23/2024 - 09:24 July 23, 2024 — EMVision , an Australian medicaldevice company focused on the development and commercialization of innovative portable brain scanning technology, has today unveiled its First Responder Proof of Concept device, designed for deployment via road and air ambulances.
What to Do On December 16, 2023, Philips sent all affected customers an Urgent MedicalDevice Correction letter. Additional Resources MedicalDevice Recall Database Entries BrightView, gamma camera system BrightView X, gamma camera for SPECT BrightView XCT, gamma camera for SPECT How do I report a problem?
XENOVIEW VDP was built using 3D Slicer , an open-source medical imaging software that Kitware helps develop, and provides advanced 3D image analysis and structured clinical reporting tailored to the lung images acquired by XENOVIEW MRI technology. For more information: www.kitware.com Friday, August 18, 2023 - 16:24
AI-driven MRI analysis opens the possibility of accessing previously unavailable clinically-relevant information to reinforce radiology workflows, especially in the context of neurological disorders.” Additionally, Pixyl.Neuro has received the CE-mark class IIa certification in the European Union under the new MedicalDevice Regulations.
milla1cf Thu, 09/14/2023 - 15:05 September 14, 2023 — Insight Medbotics, a medicaldevice company combining the accuracy of MRI with the precision of robotics, today announced a successful 510(k) clearance from the U.S. Insight Medbotics has demonstrated IGAR’s safety and efficacy through published clinical studies in breast biopsy.
NeuroShield is currently in clinical use in over 220+ sites across the world. A trial of 280 subjects drawn from different parts of the US demonstrated the product's high accuracy across scanners of different magnetic strengths, clinical subgroups, gender, age, slice thickness, and US geographic regions. References: [i] JOSHI, J.
Recognized as one of the most demanding regulatory pathways globally, the approval process is overseen by the FDA to ensure medicaldevices are safe and effective when introduced into the United States. The operating room faces enormous challenges in terms of patient volume and complexity. We aim to alleviate these pressures.
GE HealthCare is also collaborating with Nuance and Microsoft on a research technology project that is intended to automatically assembles relevant prior studies/reports and summarizes significant content for radiologists in the imaging workflow (3). According to the company statement released Nov. 22, GE HealthCare has topped a U.S.
milla1cf Tue, 12/12/2023 - 09:22 December 12, 2023 — GT Medical Technologies, Inc. , and global brachytherapy, focusing on, and investing in improved outcomes for patients with multiple tumors using a single best in class isotope.
Deep 6 AI has partnered with Graticule to design research algorithms and real-world data services for identifying and prioritizing patients for clinical trials across different disease indications.
In addition to enhancing image clarity and accuracy, the V6 is adaptable in various medical settings through its remote access, simplified workflows, wide screen and compact, powerful design with a battery option, increasing accessibility and versatility for healthcare providers. “The
Researchers from Cedars-Sinai Medical Center in Los Angeles are among those monitoring the clinical and investigational role of AI in advanced cardiac CT imaging. insurance claims data to study the clinical adoption of medical AI devices in the U.S. AI adoption patterns When an AI tool is cleared by the U.S.
AI medicaldevice company Bot Image is highlighting the performance of its ProstatID in a study evaluating its ability to detect, diagnose, and screen for prostate cancer. The device, which has clearance by the U.S. It uses a linearly scaled risk score and the PI-RADS case scoring system.
Siemens Healthineers company Varian will distribute medicaldevice company Innova Vascular's Laguna Thrombectomy System for treating venous thromboembolism. The system features a simplified setup process, flexibility and trackability, and a comprehensive range of sizes, according to the company.
Are tattoos and implantable medicaldevices safe? While we are familiar with medical safety and ethics principles when errors occur, the culture of blaming parties is still prevalent," noted Ana Paula Santos Lima, MD, assistant professor of radiology at the University of Washington, and colleagues. How can quenching be avoided?
Reading Time: 9 minutes read Mid-cycle refresh can increase clinical, operational, and security benefits. Does it support new medical imaging software that can help improve clinical outcomes? In visits to clinics and hospital departments, we interact with technologists often.
AI medicaldevice developer Imidex and DNA sequencing technology company Orbit Genomics have established a partnership to develop a combined approach for diagnosing lung cancer. The companies are preparing to start clinical trials.
will unveil its AI-powered lung cancer continuum at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, from May 31 to June 4. The end-to-end care continuum is designed to support clinicians and promote developments for lung health in the pharmaceutical and medicaldevice industries.
At RSNA, the company will showcase its App Orchestrator, an application orchestration solution that can give customers easy access to multiple applications from multiple companies, and CardioVisio, an AFiB patient management dashboard designed to save time, improve clinical confidence, and deliver precision care, GE HealthCare said.
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