AuntMinnie

OCTOBER 24, 2024

Despite reported issues with CT scanning interfering with certain medical devices, the U.S. Food and Drug Administration (FDA) has said CT is still the preferred imaging modality for patients with medical devices. Read the FDA's full guidance here.

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Medical Device Magnetic Resonance Imaging Medical Fluoroscopy 52

AuntMinnie

APRIL 30, 2024

Large language models such as ChatGPT and Google Gemini fall short in breast imaging, a study published April 30 in Radiology found. Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com. Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com.

Imaging 119

Imaging Medical Device Radiologist Clinic 119

Imaging Technology

JANUARY 26, 2024

milla1cf Fri, 01/26/2024 - 21:11 January 26, 2024 — InkSpace Imaging , a leader in innovative diagnostic medical device 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.

Medical Device 105

Medical Device Imaging MRI Patient Care 105

Imaging Technology

JULY 17, 2024

mtaschetta-millane Wed, 07/17/2024 - 10:52 July 17, 2024 — Hyperfine , a groundbreaking medical device 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.

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Medical Device Imaging Patient Care Medical 111

Health Imaging

DECEMBER 1, 2023

Cybersecurity consultant Richard Staynings argued legacy medical devices are inherently insecure—and likely to remain in hospitals for decades to come.

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Hospital Medical Device Imaging Medical 111

Open Medscience

MARCH 23, 2023

The post Why Cybersecurity is Non-Negotiable for Medical Devices in 2023 appeared first on Open Medscience. As the world becomes increasingly connected, cyber threats have become a critical concern for every industry, including healthcare.

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Medical Device Medical Healthcare Healthcare 52

Imaging Technology

JANUARY 9, 2024

a medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system—announced the launch of the AI-powered eighth generation of Swoop system software. milla1cf Tue, 01/09/2024 - 11:12 January 9, 2024 — Hyperfine, Inc. ,

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Imaging Communication Medical Device Hospital 104

AuntMinnie

JULY 25, 2024

AI developers can recognize and avoid pitfalls when creating models and tools for interpretative imaging performance, according to an analysis published July 24 in the American Journal of Roentgenology. Radiology departments continue to adopt AI imaging tools into their clinical workflows. Image courtesy of the ARRS.

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Imaging Medical Device Image Interpretation Radiologist 105

Imaging Technology

DECEMBER 13, 2023

milla1cf Wed, 12/13/2023 - 10:50 December 13, 2023 — The X-ray fluoroscopy machine is a medical device frequently used in orthopedic surgery. Despite its imaging capabilities, physicians heavily rely on their experience and knowledge to align the 3D shape of the target area using the 2D X-ray image.

X-ray 105

X-ray Fluoroscopy Imaging Medical Device 105

Imaging Technology

JULY 17, 2024

mtaschetta-millane Wed, 07/17/2024 - 10:58 July 17, 2024 — LG Electronics (LG) is accelerating its B2B medical device business, expanding its lineup of diagnostic monitors with the new 21HQ613D-B, which was recently cleared by the U.S. Food and Drug Administration for sale in the U.S.

Diagnostic 105

Diagnostic Imaging DICOM Medical Device 105

Imaging Technology

AUGUST 18, 2023

milla1cf Fri, 08/18/2023 - 16:24 August 18, 2023 — Kitware , a leader in developing innovative medical visualization software, is pleased to announce its successful collaboration with Polarean, Inc. – a medical imaging technology company and long-standing customer – and their recent FDA -approval of their lung imaging technology.

Imaging 97

Imaging Medical Device Medical Imaging Medical 97

Imaging Technology

JUNE 19, 2024

a manufacturer of industry-leading mini C-arm imaging devices specifically designed for orthopedic procedures. to secure its imaging devices and comply with recent FDA cybersecurity regulations. sought a software solution that would meet stringent regulatory requirements and harden its devices against cyberattacks.

Medical Device 105

Medical Device Quality and Compliance Medical IT 105

Imaging Technology

FEBRUARY 15, 2024

.: 553 Date Initiated by Firm: December 15, 2023 Device Use The Philips Brightview system is a Single Photon Emission Computed Tomography ( SPECT ) machine used to take images showing biological activity in the human body, for medical personnel to review. Contact Information Customers in the U.S.

Computed Tomography 95

Computed Tomography Imaging Medical Device Radiopharmaceuticals 95

Imaging Technology

OCTOBER 12, 2023

a groundbreaking medical device 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.

Imaging 105

Imaging Medical Device Education Patient Care 105

Health Imaging

NOVEMBER 4, 2024

The new code family was created to "capture the physician work involving patients with implanted medical devices that require access to MR diagnostic procedures."

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Medical Device MRI Diagnostic Medical 111

Imaging Technology

JUNE 23, 2023

milla1cf Fri, 06/23/2023 - 21:55 June 23, 2023 — Polarean Imaging plc , a medical imaging company, announced that the Company’s Board of Directors has appointed Christopher von Jako, Ph.D. Before joining Dynatronics, Dr. von Jako served as President and CEO of NinePoint Medical, Inc., He earned a double B.S.

Magnetic Resonance Imaging 98

Magnetic Resonance Imaging Imaging Medical Device Medical 98

Imaging Technology

FEBRUARY 1, 2024

milla1cf Thu, 02/01/2024 - 17:14 February 1, 2024 — Theragenics Corporation , a global leader in minimally invasive brachytherapy, interventional devices, surgical products, and medical device design services, today announced the appointment of Mark Pugh as its new CEO, effective immediately.

Medical Device 102

Medical Device Medical IT 102

Imaging Technology

JULY 7, 2023

milla1cf Fri, 07/07/2023 - 21:42 July 7, 2023 — X-ray manufacturer KA Imaging is unveiling its Reveal Mobi Pro dual-energy mobile X-ray system. The product, which is a collaboration with UMG/Del Medical, will be showcased at the upcoming AHRA Annual Meeting. KA Imaging has booth #329.

X-ray 97

X-ray Imaging Medical Device Radiograph 97

Imaging Technology

APRIL 16, 2024

milla1cf Tue, 04/16/2024 - 12:21 April 16, 2024 — QT Imaging Holdings, Inc. , Simmons, who has been caring for women with breast disease for over 20 years, knows the increasing need for safe imaging in the younger population. We need a safe imaging solution for young women. I am hopeful that QTI’s technology is that solution.”

IT 105

IT Imaging Medical Device Ultrasound 105

AuntMinnie

MAY 14, 2024

In a May 13 letter to representatives Kay Granger (R-TX) and Rosa DeLauro (D-CT) and senators Patty Murray (D-WA) and Susan Collins (R-ME), the groups noted that in radiology, AI is being used to help read and interpret images and help make more informed diagnoses. Food and Drug Administration has approved or cleared, the groups noted.

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Medical Device Radiology Medicare Healthcare 97

Imaging Technology

AUGUST 9, 2023

With the aim of exploring a safer, more accessible solution for hydrocephalus patients, the HOPE PMR study is assessing the feasibility of integrating the Swoop system, a brain imaging solution with zero ionizing radiation that is accessible at a child's bedside, into routine inpatient, outpatient, and emergency pediatric care settings.

Magnetic Resonance Imaging 98

Magnetic Resonance Imaging Inpatient Imaging Radiation 98

AuntMinnie

MARCH 19, 2024

France-based medical device developer inHeart has received clearance from the U.S. The company’s AI software module offers interactive 3D models of the heart generated by AI that analyzes preprocedural CT or MR images. Food and Drug Administration (FDA) for its AI-driven digital twin of the heart.

Medical Device 98

Medical Device Hospital Medical IT 98

Everything Rad

APRIL 10, 2023

How would you rate the value you are getting from your current X-ray imaging equipment? Does it support new medical imaging software that can help improve clinical outcomes? If not, consider investing in an affordable mid-cycle refresh to increase the value and extend the usefulness and life of your imaging equipment.

X-ray 98

X-ray Imaging Quality and Compliance Radiograph 98

Imaging Technology

SEPTEMBER 7, 2023

milla1cf Thu, 09/07/2023 - 13:59 September 7, 2023 — The groundbreaking AURA 10 specimen imager by Belgian MedTech pioneer XEOS has been cleared by the FDA. The FDA approval is a momentous achievement that underscores our commitment to propel healthcare forward through cutting-edge imaging solutions,” says Roel Van Holen , CEO of XEOS.

Imaging 105

Imaging Medical Device Patient Care Healthcare 105

AuntMinnie

NOVEMBER 18, 2024

While academic medical center radiology departments are expanding significantly and hospitals are adapting to health system consolidation trends, demand for innovative imaging informatics remains strong among operations and physician teams. billion healthcare facility.

Digital Imaging and Communications in Medicine 105

Digital Imaging and Communications in Medicine Imaging Radiology Revenue Cycle Management 105

AuntMinnie

JULY 2, 2024

The board of directors at AI imaging firm Body Vision Medical has named Matt Baker as the company's chief executive officer (CEO). He has more than 30 years of experience in the global medical device and healthcare IT industries. He replaces David Webster, who has stepped down from the role.

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Medical Device Medical Healthcare Healthcare 96

AuntMinnie

MAY 9, 2024

Food and Drug Administration (FDA)-authorized radiology-specific AI products intended for use in a variety of applications that use diagnostic imaging data, Thorwarth's letter noted for Congress. As of May 6, the ACR estimated that there are approximately 250 U.S. William Thorwarth Jr.,

Medical Device 115

Medical Device Government Patient Care Diagnostic Imaging 115

Imaging Technology

JULY 25, 2023

Through its role as manufacturer, Positron will be able to observe and comply with FDA requirements and perform future device and procedural reviews more efficiently. Going forward Positron will adhere to all FDA requirements, quality systems regulations, and import regulations.

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Medical Medical Device Communication IT 98

Diagnostic Imaging

APRIL 18, 2023

Powered by artificial intelligence (AI), the Rapid NCCT Stroke modality is reportedly the first medical device to gain FDA 510(k) clearance for detecting suspected large vessel occlusion and intracranial hemorrhage based on assessment of non-contrast computed tomography (NCCT).

Computed Tomography 98

Computed Tomography Medical Device Medical 98

Imaging Technology

JUNE 18, 2024

The Attrius is a 2D quantitative PET scanner that is designed for nuclear cardiology, providing high-resolution images in tandem with robust blood flow data for analysis optimal for the latest in coronary flow reserve software, assisting the generation of accurate measurements of absolute blood flow and coronary flow reserve.

Computed Tomography 105

Computed Tomography Medical Device Clinic Imaging 105

Imaging Technology

JUNE 14, 2024

Positron joins forces with the coalitions founding members, Bracco Diagnostics , CDL Nuclear Technologies and Siemens Healthcare who have come together to promote federal policies that advance health outcomes for patients with cardiovascular disease and improve the availability of cardiac PET diagnostics throughout the United States.

Computed Tomography 105

Computed Tomography Medical Device Education Healthcare 105

Imaging Technology

JUNE 13, 2024

Positron’s ownership of the existing 510(k) and FDA clearance will enable the marketing and sale of the NeuSight PET-CT 64 slice imaging system. PET-CT imaging remains at the forefront of oncology studies and has become vital to the future of nuclear cardiology.

Computed Tomography 104

Computed Tomography Medical Device Medical Hospital 104

Imaging Technology

DECEMBER 20, 2023

HFO, a magnetic resonance imaging (MRI) system, due to a risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas. HFO Product Codes: LNH Model Numbers: 781250 and 781350 Distribution Dates: January 1, 2001 to October 1, 2016 Devices Recalled in the U.S.:

Magnetic Resonance Imaging 105

Magnetic Resonance Imaging Medical Device Medical MRI 105

Imaging Technology

JULY 15, 2024

This advancement builds upon the existing PCD capabilities with groundbreaking enhancements, further solidifying OmniTom Elite's position at the forefront of mobile CT imaging technology. Helical Scanning Capability: This new feature allows for continuous spiral scanning, providing a faster and more efficient imaging process.

Computed Tomography 110

Computed Tomography Medical Device Diagnostic Medical 110

AuntMinnie

MAY 15, 2024

Health Canada has issued a medical device license to KA Imaging for its Reveal Mobi Pro x-ray system. Reveal Mobi Pro is a dual-energy mobile x-ray scanner that integrates KA Imaging’s Reveal 35C detector with SpectralDR technology into a complete system.

X-ray 52

X-ray Medical Device Imaging Medical 52

AuntMinnie

JANUARY 30, 2024

AI medical device 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. Compared with the device, they achieved an AUC of 0.742.

Medical Device 52

Medical Device Imaging Diagnose Clinic 52

Imaging Technology

JANUARY 23, 2024

milla1cf Tue, 01/23/2024 - 13:53 January 23, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of syngo Virtual Cockpit, a private, secure communication platform for real-time image visualization, acquisition, and collaboration between healthcare professionals across multiple sites.

Computed Tomography 110

Computed Tomography Radiology Technologist Medical Device Patient Safety 110