AuntMinnie

DECEMBER 18, 2024

Congress on December 17 by the House Task Force on AI, noting its recommendations to develop a formalized payment pathway for AI medical devices. AdvaMed commended the end-of-year report submitted to the U.S. We look forward to continuing to work with [the U.S.

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Open Medscience

MAY 23, 2025

Learn about medical device cybersecurity risks as cyber criminals target vulnerable devices to access sensitive health data. The post Practice Good Cybersecurity Habits: How To Prevent Hackers From Accessing Personal Medical Devices appeared first on Open MedScience.

Medical Device 52

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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.

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AuntMinnie

APRIL 23, 2025

The experience imaging device manufacturers have in AI-enabled medical devices makes their experiences critical to policymaking in this space. What is an AI medical device? However, what is an AI medical device? What does an AI medical device look like? Is it AI by itself?

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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.

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AuntMinnie

JUNE 13, 2025

Analysis provided is intended to inform primary diagnostic and patient management decisions and is not intended as a replacement for a complete clinician's review or their clinical judgement, according to the rule. The FDA also identified special controls that apply, such as design verification and validation requirements, and labeling requirements.

Radiology 208

Radiology Computed Tomography Medical Device Radiography 208

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

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

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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.

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Medical Device X-ray Medical Radiologist 98

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

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.

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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.

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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.

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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 265

Medical Device Imaging X-ray Clinic 265

AuntMinnie

MARCH 11, 2025

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. Food and Drug Administration (FDA).

Medical 130

Medical X-ray Medical Device Imaging Modalities 130

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.

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Medical Device Imaging Medical 230

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 105

Medical Device Medical IT Medical Imaging 105

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 218

Medical Device MRI Healthcare Healthcare 218

AuntMinnie

APRIL 16, 2025

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. But 4 out of 10 times, they may have to come back out, for a variety of different reasons."

Imaging 130

Imaging Medical Device Medical Imaging X-ray 130

AuntMinnie

APRIL 11, 2025

With its comments, ACR addressed and clarified risk management approaches throughout the total product life cycle of AI-enabled medical devices, including radiology AI. The full document is available at the ACR, here.

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AuntMinnie

JULY 2, 2024

He has more than 30 years of experience in the global medical device and healthcare IT industries. While the company did not give a reason for Webster's stepping down, it highlighted that during Webster's time as CEO, he oversaw the expansion of Body Vision Medical's global reach from two markets to nearly 50.

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Medical Device Medical Healthcare Healthcare 240

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

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

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

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

They also determined the 25 drugs and medical devices associated with the largest total payments. million), while the three medical devices associated with the most payments were the da Vinci Surgical System ($307.5 Topping the list were orthopedic surgeons, who received the greatest sum of payments over the period at $1.36

Radiologist 278

Radiologist Medical Device Education Medical 278

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

AuntMinnie

MAY 9, 2024

CMS currently has physician-led mechanisms for determining whether a new service or medical device provides patient care value, and physician leadership must continue in any future AI reimbursement paradigm, Thorwarth noted.

Medical Device 289

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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.

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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

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AuntMinnie

NOVEMBER 9, 2023

If this deep-learning model becomes available as a medical device, chest x-rays taken in a variety of settings, such as medical examinations, checkups, and hospitals, could be used to screen for osteoporosis,” Sato and colleagues suggest. The model achieved 79% accuracy, 96.6% sensitivity, and 34.1% accuracy, 77.1%

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X-ray Medical Device Radiographer Radiograph 223

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 265

Imaging Medical Device Image Interpretation Radiologist 265

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

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AuntMinnie

JULY 22, 2024

has received a Class III medical device license from Health Canada for all its medical imaging AI products. The license allows the company to expand its presence into the Canadian healthcare market, according to the vendor.

X-ray 163

X-ray Medical Device Radiography Medical Imaging 163

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

AuntMinnie

FEBRUARY 1, 2024

The list gathers insight from incident investigations, reporting databases, and independent medical device testing.

Medical Device 130

Medical Device Government Patient Care Healthcare 130

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.

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