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.

Hospital 278

Hospital Medical Device Imaging Medical 278

AuntMinnie

MARCH 11, 2025

AI medical imaging firm Gleamer has acquired two developers of AI-powered MRI applications, Pixyl and Caerus Medical. Pixyl is the developer of Pixyl.Neuro, which is CE-marked and has been cleared as a Class IIa medical device by the U.S. Financial and other details of the acquisitions were not disclosed.

Medical 130

Medical X-ray Medical Device Imaging Modalities 130

Radiology Business

FEBRUARY 25, 2025

Food and Drug Administration clearance for its Ezra Flash, a class 2 medical device. The New York-based healthcare AI firm has scored U.S.

Medical Device 241

Medical Device MRI Imaging Healthcare 241

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.

Imaging 264

Imaging Medical Device Image Interpretation Radiologist 264

AuntMinnie

MARCH 4, 2025

Philips 's Image Guided Therapy Services division has sent out an urgent medical device recall letter for its Tack Endovascular System, according to a March 3 announcement from the U.S. The FDA is classifying this recall as the "most serious type," noting that the device can "cause serious injury or death."

Medical Device 130

Medical Device Healthcare Healthcare Medical 130

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."

Medical Device 279

Medical Device MRI Diagnostic Medical 279

Imaging Technology

NOVEMBER 15, 2023

USEI), a reputable medical device manufacturing company with over 25 years of experience announced it has been acquired by Intellectt, Inc., Founded in 1994, USEI is an ISO 13485-certified medical device manufacturing company specializing in medical monitors and accessories. Electronics, Inc. Intellectt, Inc.

Medical Device 105

Medical Device Medical Quality and Compliance Medical Imaging 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.

Medical Device 243

Medical Device Radiology Medicare Healthcare 243

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.

Medical Device 240

Medical Device Medical Healthcare Healthcare 240

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 246

Medical Device Hospital Medical IT 246

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 288

Medical Device Government Patient Care Diagnostic Imaging 288

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 130

X-ray Medical Device Imaging Medical 130

Atlantis Worldwide

SEPTEMBER 4, 2024

The FDA announced that it stands behind the proposed exemption from the Digital Millennium Copywrite Act that would apply “to circumvention (of technological protections) that is conducted solely to

Medical Device 89

Medical Device Medical IT Medical Imaging 89

Open Medscience

JUNE 23, 2024

Medical Device Regulatory Compliance ensures safety and effectiveness through stringent testing and approval processes globally. The post Regulatory Compliance and Approval Processes in Medical Devices appeared first on Open MedScience.

Medical Device 52

Medical Device Medical PACS 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 130

Medical Device Imaging Diagnose Clinic 130

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.

X-ray 162

X-ray Radiography Medical Device Medical Imaging 162

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 130

Medical Device Government Medical Medical Imaging 130

MRI Network

JANUARY 8, 2024

The need for more remotely accessible services like telemedicine and a range of advanced medical devices is accelerating growth across the industry. Recent reports highlight that the MedTech (medical technology) industry is set to grow to a value of $595 billion in 2024.

Medical Device 59

Medical Device Medical Pharmaceutical Healthcare 59

AuntMinnie

JANUARY 13, 2025

The rapid maturation of AI-powered medical imaging technology leaves me bullish that 2025 will be remembered as a watershed year in the global fight against cancer as we see more radiologists and oncologists equip themselves with the high-tech tools of tomorrow to deliver higher-quality care today. Roland Rott of GE HealthCare.

Radiation Oncology 337

Radiation Oncology Diagnostic X-ray Radiation 337

Imaging Technology

DECEMBER 3, 2024

“Med Dream’s Universal DICOM Viewer enables healthcare professionals to access medical images anytime, from any device, ensuring continuous availability. It is FDA cleared for diagnostic use and certified as a Class IIB medical device in accordance with the European Medical Device Regulation (MDR).

DICOM 52

DICOM Medical Device PACS Patient Care 52

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.

Medical Device 111

Medical Device Imaging Medical Patient Care 111

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

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.

Imaging 133

Imaging Computed Tomography Medical Device Radiologist 133

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.

Medical Device 130

Medical Device Government Patient Care Healthcare 130

AuntMinnie

MAY 9, 2024

Food and Drug Administration (FDA) has issued final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair. One imaging example the FDA used in its final guidance was replacing a damaged gradient coil in an MR system.

Medical Device 130

Medical Device Medical IT Imaging 130

AuntMinnie

NOVEMBER 15, 2023

For instance, the suite features automation of preliminary echocardiographic reports of key measurements of the heart that can help detect valvular diseases, like aortic stenosis, and provide image quality assessments, Butterfly said.

Medical Device 147

Medical Device Ultrasound Disease Medical 147

AuntMinnie

DECEMBER 11, 2023

Are tattoos and implantable medical devices 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?

MRI 290

MRI Medical Device X-ray Radiography 290

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 100

Medical MRI Medical Device Imaging 100

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.

Medical Device 52

Medical Device Medical Healthcare Healthcare 52

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 18, 2023

The Medical Imaging and Technology Alliance (MITA) has launched a new educationa.

Education 130

Education Medical Device Medical Imaging Medical 130

AuntMinnie

JUNE 6, 2024

Radiology informatics firm aycan has inked a reseller and technology partnership with AI4MedImaging, a company that specializes in applying AI to medical imaging. Aycan said it plans to resell future products from AI4MedImaging and work with the company to integrate its AI technology into other partner solutions.

DICOM 130

DICOM Medical Device Medical Imaging Medical 130

AuntMinnie

FEBRUARY 19, 2025

Scottsdale, AZ-based outpatient medical imaging provider SimonMed Imaging will deploy HeartLung Technologies AI software for osteoporosis screening on CT scans. Under the agreement, SimonMed will integrate the software as an add-on to CT scans.

X-ray 130

X-ray Medical Device Radiation Medical Imaging 130

AuntMinnie

JUNE 7, 2023

The Medical Imaging and Technology Alliance (MITA) has expressed concern ove. discussion

Medical Device 130

Medical Device Radiopharmaceuticals Medical Imaging Medical 130

AuntMinnie

DECEMBER 11, 2023

In a session on chest imaging, scientists from AI developers Lunit and DeepTek.ai presented separate studies of AI algorithms configured to segregate patient chest x-ray images into those with significant clinical findings and those considered normal. In both cases, the algorithms ruled out a potentially significant number of reads.

X-ray 230

X-ray Radiologist Medical Device Radiograph 230

AuntMinnie

FEBRUARY 2, 2025

French imaging software developer Median Technologies is highlighting results from the RELIVE clinical trial regarding its AI-based CADe/CADx software as a medical device for lung cancer screening, eyonis LCS.

Clinic 130

Clinic Medical Device Diagnostic Radiologist 130

Imaging Technology

FEBRUARY 21, 2025

Today, healthcare providers often rely on disparate data sources, including static Electronic Medical Record (EMR) data, clinical notes and isolated device alarms.

Patient Care 52

Patient Care Medical Device Electronic Medical Record Clinic 52