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

AuntMinnie

AUGUST 9, 2024

In silico imaging trials represent a viable source of regulatory evidence for imaging device evaluation, according to an analysis conducted by the U.S. Then, FFDM and DBT images were simulated using a physics-based Monte Carlo x-ray transport code. a clinician model). "The Read the full paper here.

Medical Device 105

Medical Device Imaging X-ray Clinic 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 Medical Patient Care 111

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

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

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.

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Imaging Medical Device Radiologist Clinic 119

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 99

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 96

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

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

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

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

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.

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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

AuntMinnie

NOVEMBER 13, 2024

Fluorescence-guided imaging technology company Lumicell has appointed Howard Hechler as CEO. His prior experience spans investment banking, management consulting, and extensive partnering work at large medical device and biopharmaceutical companies, including Medtronic, Smith & Nephew, and Mallinckrodt Pharmaceuticals, Lumicell noted.

Pharmaceutical 52

Pharmaceutical Medical Device Medical Imaging 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

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

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

NOVEMBER 8, 2024

The MR 5300 with BlueSeal technology is designed to provide helium-free MR imaging capabilities in a mobile format, increasing access to care with advanced medical diagnostics for communities in both rural and urban areas. The relationship with Shared Medical Services has been wonderful.

Medical 59

Medical Imaging Nuclear Medicine Medical Device 59

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

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

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.

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X-ray Imaging Medical Device Radiographer 97

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

AuntMinnie

JUNE 7, 2024

Court of Appeals District of Columbia Circuit ruling that the trade group said will prevent "unauthorized and unregulated repair companies from hacking into life-saving medical devices." AdvaMed and the Medical Imaging and Technology Alliance (MITA) filed the lawsuit against the U.S.

Medical Device 52

Medical Device Government Medical Medical Imaging 52

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.”

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IT Imaging Medical Device Ultrasound 105

Open Medscience

MARCH 30, 2023

The increasing connectivity of medical devices highlights the need for robust cyber security measures. The post Digital Defenses in Radiology: Cyber Security in Medical Imaging Systems appeared first on Open Medscience.

Medical Imaging 59

Medical Imaging Medical Medical Device Radiology 59

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

AuntMinnie

OCTOBER 24, 2024

offers automation of the image processing steps, which the company said can lead to a reduction in operator time without compromising the accuracy of the measurements. already has a Medical Device License in Canada and is under review by the U.S. in the European Union.

Ultrasound 52

Ultrasound Medical Device Diagnostic Medical 52

AuntMinnie

NOVEMBER 27, 2023

German medical device manufacturer Ulrich Medical and Bracco Imaging are entering a strategic cooperation agreement for Bracco to distribute an MRI contrast media injector as soon as it becomes commercially available in the U.S.

Medical 40

Medical MRI Medical Device Imaging 40

AuntMinnie

JULY 22, 2024

has received a Class III medical device license from Health Canada for all its medical imaging AI products. The Class III license covers all of Qure.ai's flagship software, including qXR for chest x-ray images, cER for triaging neurocritical CT images, and qCT for lung nodule management on chest CT images.

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X-ray Radiography Medical Device Medical Imaging 64

AuntMinnie

SEPTEMBER 12, 2024

In his talk, Rajiv Gupta, MD, PhD, from Massachusetts General Hospital outlined the state of AI in medical imaging and for CT specialists. The number of AI-based medical devices cleared by the U.S. Of these devices, 76% are intended for use by radiologists. And regulatory bodies are also getting on board with AI.

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Imaging Computed Tomography Medical Device Radiologist 53

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 Radiographer 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.

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Imaging Medical Device Patient Care Healthcare 105

AuntMinnie

FEBRUARY 1, 2024

Nonprofit healthcare consultancy Emergency Care Research Institute (ECRI) has released its list of the most pressing health technology safety hazards for 2024, which includes multiple concerns related to AI and data security that could apply to imaging.

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Medical Device Government Patient Care Healthcare 52

Aidoc

FEBRUARY 5, 2024

The adoption of artificial intelligence (AI) in medical imaging has experienced substantial growth in recent years, with more than 450 AI-based medical devices gaining approval in both Europe and the USA. Vendor B 62.8%

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PACS DICOM Imaging Medical Device 59