Diagnostic and Medical Device - Diagnostic Imaging Brief

The Rise of AI in Medical Devices: What It Means for Hiring and Innovation

MRI Network

MARCH 27, 2025

The number of machine learning- and AI-powered medical devices approved by the U.S. In 2024, the FDA approved nearly 1,000 AI medical devices compared to just 221 in 2023. At the same time, there are concerns about whether the FDA has approved some medical devices too quickly.

Medical Device

Medical Device Medical IT Healthcare

CMS to make proposed MRI safety codes official

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

Medical Device MRI Diagnostic Medical

Hyperfine secures CE marking for Swoop portable MRI system

AuntMinnie

NOVEMBER 7, 2024

Connecticut-based company Hyperfine has secured CE marking under the European Medical Device Regulation for its Swoop portable brain MRI system. The Swoop system reduces scan times, which speeds the diagnostic process in acute care settings, Hyperfine said.

MRI

MRI Medical Device Diagnostic Medical

Intellectt, Inc. Acquires U.S. Electronics, Inc. to Bolster Medical Device Manufacturing and Staffing Expertise

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

Medical Device Medical Quality and Compliance Medical Imaging

ACR responds to Congressional query on AI reimbursement

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

Medical Device Government Patient Care Diagnostic Imaging

AI will transform early cancer detection, save lives in 2025

AuntMinnie

JANUARY 13, 2025

This nascent fields impact on radiology, in particular, has been nothing short of astonishing, ushering in a new era of diagnostic reliability and personalized cancer care. Researchers are also pairing AI models with specific targeting compounds to help improve diagnostic accuracy. Roland Rott of GE HealthCare.

Radiation Oncology

Radiation Oncology Diagnostic X-ray Radiation

How imaging AI developers can avoid pitfalls when testing algorithms

AuntMinnie

JULY 25, 2024

Postoperative changes and medical devices – Previous reports suggest that AI algorithms “are not properly trained” to recognize postoperative changes and how they impact image interpretation, the authors noted. Also, medical devices such as catheters, implants, prosthetics, or pacemakers can impact AI’s performance.

Imaging

Imaging Medical Device Image Interpretation Radiologist

What are Medical Devices? Types, Regulation, and Future Trends

Open Medscience

JUNE 23, 2024

Types of medical devices include diagnostic tools, therapeutic equipment, monitoring instruments, and surgical implements. The post What are Medical Devices? Types, Regulation, and Future Trends appeared first on Open MedScience.

Medical Device

Medical Device Medical Diagnostic X-ray

LG Launches 5MP Diagnostic Monitor for Breast Imaging

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. Hu, LG Business Solutions USA’s head of medical displays.

Diagnostic

Diagnostic Imaging DICOM Medical Device

MedDream Integrates Viewer with AWS HealthImaging

Imaging Technology

DECEMBER 3, 2024

Because of this integration, in case of a PACS disruption, physicians can access studies directly through the MedDream DICOM Viewer, thus allowing for uninterrupted diagnostics, patient care and operational efficiency. “We This demonstrates our commitment to fast, secure, and reliable diagnostics and patient care.”

DICOM

DICOM Medical Device PACS Patient Care

How can Enterprise Imaging empower radiology in the modern health network?

AuntMinnie

NOVEMBER 18, 2024

When management consultants McKinsey & Company surveyed leaders of academic medical centers, they identified patient length of stay and revenue cycle management as top performance priorities among the 20 areas surveyed. Mayer is a 30-year-plus veteran in the healthcare information technology (HIT), EI, and the medical device field.

Digital Imaging and Communications in Medicine

Digital Imaging and Communications in Medicine Imaging Radiology Revenue Cycle Management

Growth Areas in Medical Devices and Hiring For Those Roles

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

Medical Device Medical Pharmaceutical Healthcare

Median highlights clinical trial results for eyonis LCS

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

Clinic Medical Device Diagnostic Radiologist

AI education is a necessity for newest class of radiologists

AuntMinnie

AUGUST 2, 2024

In healthcare, algorithms hold the promise of increasing efficiency and, potentially, diagnostic accuracy. By investing in AI education, healthcare organizations can empower radiologists to streamline workflows, enhance diagnostic accuracy, and deliver personalized care. Morris Panner, President of Intelerad.

Education

Education Radiologist Medical Imaging Diagnostic

All 50 U.S. states address right to repair restrictions

AuntMinnie

MARCH 5, 2025

The right to repair medical devices movement is gaining momentum, with all 50 states in the U.S. If enacted, this right to repair for medical devices legislation would take effect July 1. now addressing the issue through legislation.

Medical Device

Medical Device Medical Diagnostic Hospital

Ventripoint receives CE Mark for cardiac ultrasound software

AuntMinnie

OCTOBER 24, 2024

Toronto, Ontario, Canada-based Ventripoint Diagnostics has received CE Mark certification for its VMS+4.0 already has a Medical Device License in Canada and is under review by the U.S. automated cardiac ultrasound software. in the European Union. Food and Drug Administration.

Ultrasound

Ultrasound Medical Device Diagnostic Medical

Cleerly launches Cleerly Ischemia software

AuntMinnie

JANUARY 11, 2024

Food and Drug Administration (FDA) 510(k) medical device clearance. It is intended to be a diagnostic aid for patients undergoing coronary CT angiography (CCTA) analysis using Cleerly Labs software. Cleerly is launching its Cleerly Ischemia software, which recently received U.S.

Medical Device

Medical Device Diagnostic Medical IT

Aycan touts latest version of Softneta’s MedDream DICOM viewer

AuntMinnie

NOVEMBER 1, 2023

The web-based MedDream DICOM Viewer also ensures a way to search, view, analyze, and diagnose medical images, signals, and video files from anywhere and on any device. MedDream has been cleared by the U.S.

DICOM

DICOM Medical Device Medical Imaging Diagnose

Median Technologies extends cash runway by $50M

AuntMinnie

JANUARY 24, 2025

French imaging software developer Median Technologies has secured nearly $50 million to support regulatory filings for its AI lung cancer diagnostic software as a medical device (SaMD). providers of AI diagnostics, Median said. million euros ($39.4 million) and a 10 million euro ($10.5

Computed Tomography

Computed Tomography Medical Device Diagnostic Diagnose

Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

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

Medical Device Imaging Medical Patient Care

Shared Medical Services, Nebraska Medicine Collaborate to Deploy Philips Helium-Free MR Imaging System

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. Additional information on Shared Medical Devices is available at www.sharedmed.com.

Medical

Medical Imaging Nuclear Medicine Medical Device

InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems

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

Medical Device Imaging MRI Patient Care

Positron Corporation Joins Cardiac PET Industry Coalition (CPIC)

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

Computed Tomography Medical Device Education Healthcare

RapidAI Gets FDA Nod for AI Assessment of Non-Contrast CT for Acute Stroke Triage

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

Computed Tomography Medical Device Medical

Ibex Medical Analytics Earns First FDA 510(k) Clearance for Prostate Detect

Imaging Technology

FEBRUARY 10, 2025

10, 2025 Ibex Medical Analytics recentlyannouncedit has received U.S. As cancer incidence rises worldwide, increasing demand and diagnostic workloads are compounded by a global shortage of pathologists, whose jobs are becoming more complex with advancements in precision medicine. tim.hodson Mon, 02/10/2025 - 11:56 Feb.

Medical

Medical Health Science Diagnose Medical Device

NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom Elite with Ultra-High Resolution PCD Technology

Imaging Technology

JULY 15, 2024

Advanced Image Processing Algorithm: The OmniTom Elite now supports post-reconstruction features such as Virtual Non-Contrast (VNC) and bone removal, enhancing diagnostic capabilities and image quality. We will continue to develop leading technologies to improve medical staff's convenience and diagnostic accuracy.

Computed Tomography

Computed Tomography Medical Device Diagnostic Medical

Transforming Care: How Digital Tools Reshape Diagnostics and Treatment

Open Medscience

DECEMBER 5, 2024

The post Transforming Care: How Digital Tools Reshape Diagnostics and Treatment appeared first on Open MedScience. Digital therapeutics provide innovative solutions for managing diseases, improving care accessibility, and supporting personalised treatments.

Diagnostic

Diagnostic Disease Medical Device Diagnostic Imaging

NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom Elite with Ultra-High Resolution PCD Technology

Imaging Technology

JULY 18, 2024

Advanced Image Processing Algorithm: The OmniTom Elite now supports post-reconstruction features such as Virtual Non-Contrast (VNC) and bone removal, enhancing diagnostic capabilities and image quality. We will continue to develop leading technologies to improve medical staff's convenience and diagnostic accuracy.

Computed Tomography

Computed Tomography Medical Device Diagnostic Medical

Positron Corporation Announces Attrius PET System Sale

Imaging Technology

JUNE 18, 2024

The Attrius PET is a tremendous tool for advanced cardiac studies and diagnostics. Adel Abdullah , President of Positron, stated, “We are pleased to be part of such an established practice and their expansion to include cardiac PET imaging with their current cardiac SPECT based practice.

Computed Tomography

Computed Tomography Medical Device Clinic Imaging

Esaote North America awarded MRI Ancillary Equipment and Coils agreement with Premier, Inc.

Imaging Technology

JUNE 21, 2023

Esaote's founding philosophies continue to push the technological boundaries of the medical device industry, delivering cost-effective and eco-friendly diagnostic imaging solutions to meet customer demands worldwide. Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,400 U.S.

MRI

MRI Medical Device Healthcare Healthcare

Positron Corporation Introduces New, Advanced Designed, Economically Priced PET-CT

Imaging Technology

JULY 25, 2024

mtaschetta-millane Thu, 07/25/2024 - 08:28 July 25, 2024 — Positron Corporation , a leading molecular imaging medical device company offering PET & PET-CT imaging systems, presents its new NeuSight PET-CT 3D 64 slice scanner, available for US and North American Markets.

Medical Device

Medical Device Hospital Diagnostic Clinic

Siemens Healthineers Announces FDA Clearance of syngo Virtual Cockpit Remote Scanning Technology

Imaging Technology

JANUARY 23, 2024

By deploying technologists across multiple locations in this manner, healthcare providers can address the ongoing technologist shortage as well as standardize care and achieve diagnostic consistency across the health system. This standardization can lead to a more accurate patient diagnosis.

Computed Tomography

Computed Tomography Radiology Technologist Medical Device Patient Safety

Companies Partner to Offer Artificial Intelligence-Based Bone Density Screening

Imaging Technology

MARCH 4, 2025

FDA cleared HeartLungs AutoBMD AI as a DEXA-equivalent medical device for opportunistic detection of low bone density in CT scans. "We The AI uses data with the existing CT scan images and generates a colorful and patient-friendly bone density report with Z score and T score similar to what DEXA scanners provide. References: 1.

Bone Scan

Bone Scan X-ray Medical Device Interventional Radiology

A few interventional radiologists get lion's share of industry payments

AuntMinnie

JULY 24, 2024

Interventional radiologists received an aggregate of over $60 million in payments from drug and medical device companies between 2017 and 2021, but most of this money is going to just a few of these physicians, according to research published July 24 in Current Problems in Diagnostic Radiology.

Radiologist

Radiologist Interventional Radiology Hospital Medical Device

Annalise.ai Receives FDA Clearance and Breakthrough Device Designation

Imaging Technology

SEPTEMBER 13, 2023

This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program*. The FDA's Breakthrough Devices Program identifies medical devices that improve the treatment or diagnosis of life-threatening or debilitating conditions. Annalise.ai

X-ray

X-ray Medical Device Medical Imaging Medical

Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Imaging Technology

SEPTEMBER 8, 2023

milla1cf Fri, 09/08/2023 - 16:25 September 8, 2023 — Positron Corporation , a leading molecular imaging medical device 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.

Clinic

Clinic Medical Device Radiopharmaceuticals IT

Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT

Imaging Technology

NOVEMBER 22, 2023

milla1cf Wed, 11/22/2023 - 11:56 November 22, 2023 — Lunit , a leading provider of AI -powered solutions for cancer diagnostics and therapeutics, today announced that it has received U.S. In addition, Lunit INSIGHT DBT has been cleared for Europe by being CE-marked under Europe's latest Medical Device Regulation (EU MDR) since March 2023.

X-ray

X-ray Medical Device IT Medical

XEOS Receives Approval by US FDA for the AURA 10 PET-CT Specimen Imager for the Operating Room

Imaging Technology

SEPTEMBER 7, 2023

This advancement promises to transform the landscape of intraoperative diagnostics, offering real-time insights that can make all the difference in patient care. The AURA 10 helps surgeons take informed decisions right on the spot by harnessing the power of molecular imaging.

Imaging

Imaging Medical Device Patient Care Healthcare

GE HealthCare to Spotlight Industry-Leading AI-Enabled Portfolio and Digital Solutions at HIMSS 2024

Imaging Technology

MARCH 7, 2024

milla1cf Thu, 03/07/2024 - 20:10 March 7, 2024 — GE HealthCare will showcase its industry-leading portfolio of artificial intelligence ( AI )-enabled medical devices 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.

Healthcare

Healthcare Healthcare PACS Medical Device

QT Imaging Announces Second Blinded Screening Trial Finding Its Technology Similarly Effective as Digital Breast Tomosynthesis

Imaging Technology

APRIL 16, 2024

a medical device company engaged in research, development, and commercialization of innovative body imaging systems, announced positive data regarding the diagnostic performance of QTI’s Breast Acoustic CT Scans for mass detection from its second blinded multi-reader multi-case study.

IT

IT Imaging Medical Device Ultrasound

Partnership with VIDA to streamline adoption of advanced MRI of the lungs

Imaging Technology

SEPTEMBER 11, 2023

milla1cf Mon, 09/11/2023 - 13:09 September 11, 2023 — Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging (“ MRI ”) of the lungs, announces that it has partnered with VIDA Diagnostics (“ VIDA ”), a clinical imaging intelligence company providing medical imaging software solutions which manage (..)

MRI

MRI Magnetic Resonance Imaging Medical Device Clinic

Riverain Technologies; ClearRead CT with Clear Visual Intelligence (CVI) Live at Pittsburgh VA Medical

Imaging Technology

JUNE 7, 2023

milla1cf Wed, 06/07/2023 - 19:41 June 6, 2023 — Riverain Technologies , a medical device company revolutionizing chest imaging interpretation with Clear Visual Intelligence™ (CVI), announced today that the Pittsburgh VA Medical Center is now using ClearRead CT with CVI for chest CT imaging.

Medical

Medical Image Interpretation Medical Device Radiologist

Brainlab and Fujifilm Integrate Cutting-Edge Technology, Offering Advanced Capabilities to Neurosurgery Clinicians in the US

Imaging Technology

APRIL 4, 2024

milla1cf Thu, 04/04/2024 - 12:28 April 4, 2024 — FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging solutions and Brainlab , a leading digital medical technology company, announced today that Brainlab will be the exclusive U.S. Not yet commercially available in the U.S.

Ultrasound

Ultrasound Medical Device MRI Imaging

Butterfly Network Names Joseph M. DeVivo as President and Chief Executive Officer

Imaging Technology

APRIL 24, 2023

DeVivo brings over 35 years of business leadership experience, having held leadership positions at healthcare and medical device companies, as well as non-profit organizations. DeVivo will also join Butterfly’s Board of Directors, serving as Chairman. DeVivo also serves on the Board of Governors for St.

Medical Device

Medical Device Ultrasound Healthcare Healthcare

The Rise of AI in Medical Devices: What It Means for Hiring and Innovation

CMS to make proposed MRI safety codes official

Trending Sources

Hyperfine secures CE marking for Swoop portable MRI system

Intellectt, Inc. Acquires U.S. Electronics, Inc. to Bolster Medical Device Manufacturing and Staffing Expertise

ACR responds to Congressional query on AI reimbursement

AI will transform early cancer detection, save lives in 2025

How imaging AI developers can avoid pitfalls when testing algorithms

What are Medical Devices? Types, Regulation, and Future Trends

LG Launches 5MP Diagnostic Monitor for Breast Imaging

MedDream Integrates Viewer with AWS HealthImaging

How can Enterprise Imaging empower radiology in the modern health network?

Growth Areas in Medical Devices and Hiring For Those Roles

Median highlights clinical trial results for eyonis LCS

AI education is a necessity for newest class of radiologists

All 50 U.S. states address right to repair restrictions

Ventripoint receives CE Mark for cardiac ultrasound software

Cleerly launches Cleerly Ischemia software

Aycan touts latest version of Softneta’s MedDream DICOM viewer

Median Technologies extends cash runway by $50M

Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

Shared Medical Services, Nebraska Medicine Collaborate to Deploy Philips Helium-Free MR Imaging System

InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems

Positron Corporation Joins Cardiac PET Industry Coalition (CPIC)

RapidAI Gets FDA Nod for AI Assessment of Non-Contrast CT for Acute Stroke Triage

Ibex Medical Analytics Earns First FDA 510(k) Clearance for Prostate Detect

NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom Elite with Ultra-High Resolution PCD Technology

Transforming Care: How Digital Tools Reshape Diagnostics and Treatment

NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom Elite with Ultra-High Resolution PCD Technology

Positron Corporation Announces Attrius PET System Sale

Esaote North America awarded MRI Ancillary Equipment and Coils agreement with Premier, Inc.

Positron Corporation Introduces New, Advanced Designed, Economically Priced PET-CT

Siemens Healthineers Announces FDA Clearance of syngo Virtual Cockpit Remote Scanning Technology

Companies Partner to Offer Artificial Intelligence-Based Bone Density Screening

A few interventional radiologists get lion's share of industry payments

Annalise.ai Receives FDA Clearance and Breakthrough Device Designation

Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT

XEOS Receives Approval by US FDA for the AURA 10 PET-CT Specimen Imager for the Operating Room

GE HealthCare to Spotlight Industry-Leading AI-Enabled Portfolio and Digital Solutions at HIMSS 2024

QT Imaging Announces Second Blinded Screening Trial Finding Its Technology Similarly Effective as Digital Breast Tomosynthesis

Partnership with VIDA to streamline adoption of advanced MRI of the lungs

Riverain Technologies; ClearRead CT with Clear Visual Intelligence (CVI) Live at Pittsburgh VA Medical

Brainlab and Fujifilm Integrate Cutting-Edge Technology, Offering Advanced Capabilities to Neurosurgery Clinicians in the US

Butterfly Network Names Joseph M. DeVivo as President and Chief Executive Officer

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