AuntMinnie

MAY 15, 2024

Siemens Healthineers company Varian will distribute medical device company Innova Vascular's Laguna Thrombectomy System for treating venous thromboembolism. The system features a simplified setup process, flexibility and trackability, and a comprehensive range of sizes, according to the company.

Medical Device 52

Medical Device Medical Clinic 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 91

Medical Device Imaging MRI Patient Care 91

AuntMinnie

FEBRUARY 8, 2024

The research combined AppliedVR's RelieVRx medical device with Kernel Flow and FlowVR, a compact TD-fNIRS brain measurement headset customized for use in VR to measure brain hemodynamic changes tied to pain relief. Additionally, those receiving treatment from the RelieVRx device achieved a slower breathing rate.

Medical Device 96

Medical Device Clinic Medical 96

Imaging Technology

JUNE 14, 2024

CPIC has begun its work by weighing in on 2024 final payment rules, engaging with stakeholders in the cardiac community, and developing a 2024 policy agenda.

Computed Tomography 76

Computed Tomography Medical Device Education Healthcare 76

Imaging Technology

OCTOBER 11, 2023

As a world leader monitoring more than 600 million patients each year worldwide, Philips is creating an open patient monitoring ecosystem to bring together disparate medical devices and systems on a single interface. Every day, clinicians make countless care decisions based on information from divided medical devices and systems.

Medical Device 78

Medical Device Hospital Clinic Medical 78

AuntMinnie

JANUARY 4, 2024

Deep 6 AI has partnered with Graticule to design research algorithms and real-world data services for identifying and prioritizing patients for clinical trials across different disease indications.

Electronic Medical Record 49

Electronic Medical Record Medical Device Disease Clinic 49

AuntMinnie

JUNE 13, 2024

Philips Sanger Heart and Vascular Institute, Atrium Health, in Charlotte, NC, performed the procedure that marks the medical device's launch since U.S. Vesper Medical, a wholly-owned subsidiary of Philips, developed the system. Food and Drug Administration premarket approval in December. and Poland.

Medical Device 52

Medical Device Ultrasound Disease Clinic 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. It uses a linearly scaled risk score and the PI-RADS case scoring system.

Medical Device 52

Medical Device Imaging Diagnose Clinic 52

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 97

Healthcare Healthcare PACS Medical Device 97

AuntMinnie

OCTOBER 24, 2023

EMVision Medical Devices is developing a second-generation helmet scanner, designed for road and air ambulance deployment, for bench testing. The 28-antenna prototype helmet scanner aims to address an unmet clinical need in both bedside and first responder brain imaging.

Medical Device 52

Medical Device Clinic Medical IT 52

Imaging Technology

JUNE 13, 2024

milla1cf Thu, 06/13/2024 - 20:46 June 13, 2024 — Positron Corporation , a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical support services, announced it has entered an agreement to acquire the FDA 510(k) for the NeuSight PET-CT from its cooperative (..)

Computed Tomography 77

Computed Tomography Medical Device Medical Hospital 77

Imaging Technology

SEPTEMBER 11, 2023

The companies are partnering to further enable the Polarean xenon 129 MRI platform to accelerate clinical and research use. These new products and services will be utilised to expand access to xenon 129 MRI as a lung imaging service and to investigate new indications and biomarkers in broader populations with unmet medical needs.

MRI 97

MRI Magnetic Resonance Imaging Medical Device Clinic 97

AuntMinnie

OCTOBER 23, 2023

Radiaction Medical has appointed Christopher Barys to serve as the company's U.S. The Israel-based company develops medical devices that aim to provide radiation protection to medical staff during interventional procedures. president and chief commercial officer. Earlier this year, Radiaction raised $12.6

Medical Device 52

Medical Device Radiation Medical Clinic 52

Imaging Technology

OCTOBER 9, 2023

CQ Medical marks a pivotal transformation for CIVCO Radiotherapy and Qfix, who joined forces in October 2022. Under its new mantra, Care Smarter , CQ Medical will seek to expand on the company's history of innovative clinical solutions, unmatched product depth and breadth, and a passion for customer and patient care.

Medical 92

Medical Medical Device Patient Care Radiation 92

AuntMinnie

NOVEMBER 22, 2023

At RSNA, the company will showcase its App Orchestrator, an application orchestration solution that can give customers easy access to multiple applications from multiple companies, and CardioVisio, an AFiB patient management dashboard designed to save time, improve clinical confidence, and deliver precision care, GE HealthCare said.

Healthcare 69

Healthcare Healthcare Medical Device Radiation 69

Imaging Technology

MARCH 18, 2024

This collaboration also addresses the ongoing clinical need in breast cancer therapy for the development of an inexpensive, robust, and accurate technique to identify the response, within weeks, of breast cancer to neoadjuvant chemotherapy. milla1cf Mon, 03/18/2024 - 07:00 March 18, 2024 — QT Imaging Holdings, Inc. ,

Radiation Oncology 100

Radiation Oncology Health Science Radiation Ultrasound 100

Imaging Technology

DECEMBER 6, 2023

Medical imaging is critical across healthcare, making up approximately 90% of healthcare data. It’s used by radiologists and clinicians to do screening, diagnosis and intervention, by biopharma researchers to evaluate how clinical trial patients respond to new drugs and by medical device makers to provide real-time decision support.

Medical Imaging 102

Medical Imaging Medical Device Medical Clinic 102

Imaging Technology

AUGUST 3, 2023

The SDK can be leveraged by artificial intelligence ( AI ) software developers, medical device companies building ultrasound into their platforms, and telemedicine companies adding ultrasound into their virtual care workflows.

Ultrasound 78

Ultrasound Medical Device Education Clinic 78

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 88

Imaging Medical Device Education Patient Care 88

AuntMinnie

JUNE 6, 2024

Researchers from Cedars-Sinai Medical Center in Los Angeles are among those monitoring the clinical and investigational role of AI in advanced cardiac CT imaging. insurance claims data to study the clinical adoption of medical AI devices in the U.S. AI adoption patterns When an AI tool is cleared by the U.S.

Disease 105

Disease Hospital Clinic Imaging Modalities 105

Aidoc

JUNE 16, 2024

With that in mind, there comes an array of things to consider as it relates to AI what it does at the level of clinical care: What does AI help hospitals accomplish right now? To date, the FDA has over 850 AI/ML-enabled medical devices listed on its website. How widely has AI been adopted?

Hospital 52

Hospital Medical Device Healthcare Healthcare 52

Imaging Technology

JUNE 21, 2023

Compared to conventional scanners, the O-scan has a compact footprint that can fit into almost any clinical setting and a comfortable, open-concept design that is ideal for scanning children and claustrophobic patients," says Stephen Gibbs , Marketing and Sales Manager at Esaote North America, Inc.

MRI 85

MRI Medical Device Healthcare Healthcare 85

Imaging Technology

MAY 2, 2024

milla1cf Thu, 05/02/2024 - 10:22 May 2, 2024 — GT Medical Technologies, Inc. ( Michael Krachon , President of Theragenics Interventional, added, “This partnership reinforces Theragenics’ unwavering commitment to brachytherapy.

Medical 52

Medical Medical Device Radiation Healthcare 52

Imaging Technology

DECEMBER 5, 2023

AI-driven MRI analysis opens the possibility of accessing previously unavailable clinically-relevant information to reinforce radiology workflows, especially in the context of neurological disorders.” Additionally, Pixyl.Neuro has received the CE-mark class IIa certification in the European Union under the new Medical Device Regulations.

MRI 95

MRI Patient Care Disease Medical Device 95

Imaging Technology

JUNE 1, 2023

is certified under the new European MDR (Medical Device Regulation). aycan workstation is an FDA 510(k) cleared, vendor-neutral, highly functional advanced image-processing tool and DICOM PACS workstation for conventional, multi-slice, and other image reading with clinical and workflow plugins that further enhance its capabilities.

DICOM 52

DICOM Medical Device PACS Medical Imaging 52

Aidoc

MARCH 19, 2024

Beginning as point solutions intended to solve singular hospital pain points, clinical AI has since widened its scope and is making a crater-sized impact throughout the healthcare enterprise. Yet with a growing body of clinical validation , there is still no single entity holding full control of AI oversight.

Medical Device 52

Medical Device Imaging Modalities Clinic Government 52

Aidoc

MARCH 19, 2024

Beginning as point solutions intended to solve singular hospital pain points, clinical AI has since widened its scope and is making a crater-sized impact throughout the healthcare enterprise. Yet with a growing body of clinical validation , there is still no single entity holding full control of AI oversight.

Medical Device 52

Medical Device Imaging Modalities Clinic Government 52

Aidoc

MARCH 19, 2024

Beginning as point solutions intended to solve singular hospital pain points, clinical AI has since widened its scope and is making a crater-sized impact throughout the healthcare enterprise. Yet with a growing body of clinical validation , there is still no single entity holding full control of AI oversight.

Medical Device 52

Medical Device Imaging Modalities Clinic Government 52

Imaging Technology

FEBRUARY 15, 2024

What to Do On December 16, 2023, Philips sent all affected customers an Urgent Medical Device Correction letter. Additional Resources Medical Device Recall Database Entries BrightView, gamma camera system BrightView X, gamma camera for SPECT BrightView XCT, gamma camera for SPECT How do I report a problem?

Computed Tomography 65

Computed Tomography Imaging Medical Device Radiopharmaceuticals 65

Aidoc

JUNE 7, 2023

Myth #1: All Healthcare AI is the same Over 500 devices are categorized as “artificial intelligence and machine learning enabled medical devices” on the FDA website. In all cases, a human is still at the center of clinical decision making. In many ways, AI is the same.

Healthcare 52

Healthcare Healthcare Medical Device Education 52

Imaging Technology

AUGUST 18, 2023

XENOVIEW VDP was built using 3D Slicer , an open-source medical imaging software that Kitware helps develop, and provides advanced 3D image analysis and structured clinical reporting tailored to the lung images acquired by XENOVIEW MRI technology. For more information: www.kitware.com Friday, August 18, 2023 - 16:24

Imaging 69

Imaging Medical Device Medical Imaging Medical 69

AuntMinnie

DECEMBER 11, 2023

AI algorithms appear to have clinical value based on detecting normal x-rays – that is, by flagging chest x-rays as normal versus abnormal, they may reduce reading times for radiologists, according to research presented recently at the RSNA meeting in Chicago. In a session on chest imaging, scientists from AI developers Lunit and DeepTek.ai

Radiologist 91

Radiologist X-ray Medical Device Radiograph 91

Vesta Teleradiology

MAY 1, 2024

The FDA premarket review for medical devices like CAD programs is likely to be augmented with additional quality and equity requirements. The 4D CNN model achieved a significantly higher area under the curve (AUC) of 87% compared to 63% for the clinical model.

Radiology 52

Radiology Quality and Compliance Medical Device Medicare 52

Imaging Technology

SEPTEMBER 14, 2023

milla1cf Thu, 09/14/2023 - 15:05 September 14, 2023 — Insight Medbotics, a medical device company combining the accuracy of MRI with the precision of robotics, today announced a successful 510(k) clearance from the U.S. Insight Medbotics has demonstrated IGAR’s safety and efficacy through published clinical studies in breast biopsy.

MRI 94

MRI Medical Device Education Clinic 94

Imaging Technology

OCTOBER 3, 2023

christine.book Tue, 10/03/2023 - 11:37 October 3, 2023 — Medical device company GT Medical Technologies, Inc. We could not have achieved these interim clinical results without the support of the doctors and patients who were part of this registry study from across the nation," said Brachman.

Radiation Oncology 104

Radiation Oncology Radiation Medical Device Diagnose 104

Imaging Technology

NOVEMBER 20, 2023

NeuroShield is currently in clinical use in over 220+ sites across the world. A trial of 280 subjects drawn from different parts of the US demonstrated the product's high accuracy across scanners of different magnetic strengths, clinical subgroups, gender, age, slice thickness, and US geographic regions. References: [i] JOSHI, J.

Pharmaceutical 76

Pharmaceutical Disease Medical Device Healthcare 76

Imaging Technology

AUGUST 9, 2023

Annalise Enterprise CTB is now CE marked as class IIb under EU Medical Device Regulation (EU MDR) and additionally has been approved for clinical use in Singapore. The solutions allow worklist prioritization which supports reporting workflow efficiency by marking critical or unremarkable cases, according to clinical needs.

X-ray 52

X-ray Medical Device Healthcare Healthcare 52