AuntMinnie

OCTOBER 24, 2024

Despite reported issues with CT scanning interfering with certain medical devices, the U.S. Food and Drug Administration (FDA) has said CT is still the preferred imaging modality for patients with medical devices. CT is safer than magnetic resonance imaging (MRI) for people with devices of unknown MRI safety status."

Medical Device 130

Medical Device Magnetic Resonance Imaging Medical Fluoroscopy 130

AuntMinnie

NOVEMBER 21, 2024

The device is the first of the 55 devices enrolled in the FDA’s Total Product Life Cycle Advisory Program (TAP) to secure marketing authorization, Ultromics said. The TAP Program, set up by the FDA in 2023, expedites patient access to medical devices.

Medical Device 162

Medical Device Medical IT 162

AuntMinnie

APRIL 16, 2025

About half of medical imaging equipment service calls are not fully resolved on the first visit, according to a new report. Analysis of anonymized data by agentic AI software developer Aquant tracked 14 medical imaging service organizations and 6,500 technicians running almost 2 million service events on nearly 300,000 assets.

Imaging 130

Imaging Medical Device Medical Imaging X-ray 130

Radiology Business

MAY 13, 2024

As of Monday, the FDA has OK'd nearly 900 AI-enabled medical devices, but CMS has only assigned payment for about 10 of them.

Medical Device 290

Medical Device Radiology Medical 290

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

MedImaging Radiography

AUGUST 21, 2023

An AI-powered medical device employs sophisticated computer vision technology to identify lung nodules and masses in chest X-rays, aiding clinicians in early lung cancer detection.

Medical Device 98

Medical Device X-ray Medical Radiologist 98

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 274

Medical Device MRI Diagnostic Medical 274

AuntMinnie

APRIL 11, 2025

AI-DSF, for example, may vary across clinical settings due to variations in workflow, systems/devices, and patient demographics," ACR Chief Executive Officer Dana Smetherman, MD, noted in ACR's comments. Typically, clinical sites must validate AI-DSF accuracy and effectiveness prior to device deployment and medical use."

Risk Management 130

Risk Management Medical Device Clinic Medical 130

AuntMinnie

JANUARY 16, 2025

Oliverio joins Actineer with over 30 years of leadership experience across the nuclear medicine, medical device, and radiopharmaceutical industries, including roles at Ionetix, Imagin Molecular, and Positron.

Nuclear Medicine 130

Nuclear Medicine Medical Device Radiopharmaceuticals Medical 130

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 company in 2023 secured initial CE certification for the Swoop system. Hyperfine said this latest approval will help position the company to launch the system broadly across Europe.

MRI 130

MRI Medical Device Diagnostic Medical 130

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 274

Hospital Medical Device Imaging Medical 274

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. Food and Drug Administration (FDA) and published August 9 in Plos Computational Biology. Read the full paper here.

Medical Device 264

Medical Device Imaging X-ray Clinic 264

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 249

Medical Device MRI Imaging Healthcare 249

Radiology Business

FEBRUARY 21, 2025

The list reportedly included the agency's head of medical device safety and 10 of the 40 staffers tasked with reviewing imaging devices.

Medical Device 248

Medical Device Imaging Medical 248

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 103

Medical Device Medical IT Medical Imaging 103

AuntMinnie

MAY 14, 2024

“From helping a physician detect polyps in a colonoscopy to prioritizing a scan showing a doctor that a patient needs an emergency intervention, AI in medical imaging benefits patients,” the groups wrote. 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

Open Medscience

MARCH 27, 2025

Clinical trials for medical devices require precise planning, regulatory expertise, and patient data management from specialized CROs. The post Contract Research Organizations in Medical Device Development appeared first on Open MedScience.

Medical Device 52

Medical Device Medical Clinic Radiopharmaceuticals 52

AuntMinnie

NOVEMBER 18, 2024

While academic medical center radiology departments are expanding significantly and hospitals are adapting to health system consolidation trends, demand for innovative imaging informatics remains strong among operations and physician teams. Another, a new hospital complex is underway at University of Utah Health.

Digital Imaging and Communications in Medicine 264

Digital Imaging and Communications in Medicine Imaging Radiology Revenue Cycle Management 264

AuntMinnie

MAY 9, 2024

Despite the wide availability of AI software in radiology, however, "licensing costs, support staffing, and the relative lack of reimbursement are barriers to acquisition, appropriate governance, and high-quality medical uses of AI," Thorwarth stated.

Medical Device 288

Medical Device Government Patient Care Diagnostic Imaging 288

AuntMinnie

FEBRUARY 25, 2025

Disposable medical devices developer Merit Medical Systems posted revenue increases in its fourth quarter of 2023 and end-of-year financial results. For the fourth quarter (end-December 31, 2024), Merit reported revenues of $355.2 million, up 9.4% compared with the same quarter in 2023.

Medical 130

Medical Medical Device IT 130

AuntMinnie

MARCH 19, 2024

France-based medical device developer inHeart has received clearance from the U.S. Food and Drug Administration (FDA) for its AI-driven digital twin of the heart. The company’s AI software module offers interactive 3D models of the heart generated by AI that analyzes preprocedural CT or MR images.

Medical Device 246

Medical Device Hospital Medical IT 246

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

MARCH 28, 2024

Despite evidence that financial conflicts of interest may influence physician prescribing and may damage patients’ trust in medical professionals, such relationships remain pervasive,” the group wrote. They also determined the 25 drugs and medical devices associated with the largest total payments. The total for all U.S.

Radiologist 277

Radiologist Medical Device Education Medical 277

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 52

Medical Device Medical Diagnostic X-ray 52

ScienceDaily

JANUARY 16, 2024

Soft robots,' medical devices and implants, and next-generation drug delivery methods could soon be guided with magnetism -- thanks to a metal-free magnetic gel developed by researchers. Carbon-based, magnetic molecules are chemically bonded to the molecular network of a gel, creating a flexible, long-lived magnet for soft robotics.

Medical 121

Medical Medical Device 121

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

JULY 25, 2024

Researchers led by Seyed Tabatabaei, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, in their clinical perspective outlined these pitfalls and made suggestions on AI model training and validation, as well as using diverse datasets.

Imaging 264

Imaging Medical Device Image Interpretation Radiologist 264

AuntMinnie

FEBRUARY 29, 2024

Disposable medical devices developer Merit Medical Systems reported revenue gains for its fourth quarter of 2023 and end-of-year financial results. For the quarter unaudited (end-December 31, 2023), Merit reported total revenue of $324.5 million, an increase of 10.6% In its cardiovascular segment, the company reported $315.2

Medical 130

Medical Medical Device IT 130

AuntMinnie

NOVEMBER 9, 2023

Presenter Yoichi Sato, MD, of Tokyo Shinjuku Medical Center in Japan, and colleagues first developed the model using patient dual-energy x-ray absorptiometry (DEXA) T-scores (bone mineral density) and chest x-rays as input. The model achieved 79% accuracy, 96.6% sensitivity, and 34.1% specificity in predicting T-scores ≤ -1.0 accuracy, 77.1%

X-ray 223

X-ray Medical Device Radiographer Radiographer 223

Imaging Technology

NOVEMBER 8, 2024

4, 2024 – Shared Medical Services, Inc. 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

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.

Medical Device 246

Medical Device Clinic Medical 246

AuntMinnie

JUNE 7, 2024

Advanced Medical Technology Association (AdvaMed) commended a U.S. 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." Food and Drug Administration] FDA-regulated medical devices."

Medical Device 130

Medical Device Government Medical Medical Imaging 130

REBEL EM

APRIL 14, 2025

Inaccurate BP readings in the ED can result in inappropriate interventions, including unnecessary medication administration or missed diagnoses. The issue of BP cuff size has been studied in manual BP cuffs previously, but there is scant literature on automatic BP cuffs.

Patient Care 121

Patient Care Diagnose Clinic Medical 121

Imaging Technology

FEBRUARY 10, 2025

10, 2025 Ibex Medical Analytics recentlyannouncedit has received U.S. Amin, MD, Vice President and Medical Director of Labcorps Hospital Systems Operating Division and Clinical Professor of Pathology and Laboratory Medicine at the University of Tennessee Health Science Center. tim.hodson Mon, 02/10/2025 - 11:56 Feb.

Medical 52

Medical Health Science Diagnose Medical Device 52

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

Open Medscience

DECEMBER 5, 2024

Weight loss medications are transforming healthcare, challenging medical devices, reshaping obesity treatment, and redefining patient outcomes globally. The post Weight Loss Medications Transform Healthcare Medical Device Giants appeared first on Open MedScience.

Medical Device 40

Medical Device Medical Healthcare Healthcare 40