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

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

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

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

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 101

Hospital Medical Device Imaging Medical 101

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. ,

Imaging 104

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

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

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

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

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 96

Medical Device Medical Healthcare Healthcare 96

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

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 97

Medical Device Radiology Medicare Healthcare 97

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

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

AuntMinnie

SEPTEMBER 6, 2024

Advanced Medical Technology Association (AdvaMed) has received accreditation from the American National Standards Institute (ANSI). ANSI accreditation comes during AdvaMed's inaugural year representing the medical imaging industry. Because ANSI is the U.S.

Medical Device 52

Medical Device Medical Imaging Medical Imaging 52

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

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 64

X-ray Medical Device Radiography Medical Imaging 64

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

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

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

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

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

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%

PACS 59

PACS DICOM Imaging Medical Device 59

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 52

Medical Device Medical IT Imaging 52

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 52

DICOM Medical Device Medical Imaging Medical 52

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

AuntMinnie

JULY 22, 2024

Kelly Huang, PhD Business Wire Cardiovascular imaging AI firm Elucid has named Kelly Huang, PhD, as the company's president and CEO. Huang has also been president, CEO, and board director at Obalon Therapeutics, a publicly traded medical device company. He holds a PhD in chemical engineering from Stanford University.

Medical Device 52

Medical Device Medical IT Imaging 52

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 Medicare 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.

Medical 98

Medical Medical Device Communication IT 98

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

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

Open Medscience

JUNE 23, 2024

Digital tools in medical imaging enhance diagnostic accuracy, streamline workflows, reduce errors, and improve overall patient care efficiency. The post The Role of Digital Tools in Medical Imaging appeared first on Open MedScience.

Medical Imaging 52

Medical Imaging Medical Imaging Image Enhancement 52

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 59

Medical Device Ultrasound Disease Medical 59

AuntMinnie

JUNE 20, 2024

Polarean Imaging , a commercial-stage medical device developer for lung MRI, has closed a $12.6 Fund continued development of enhanced versions of its Xenoview polarizer and additional imaging software products. million financing round through the Alternative Investment Market (AIM) of the London Stock Exchange.

Medical Device 52

Medical Device Hospital MRI Clinic 52