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

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

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

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

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

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.

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 278

Hospital Medical Device Imaging Medical 278

AuntMinnie

MARCH 4, 2025

Philips 's Image Guided Therapy Services division has sent out an urgent medical device recall letter for its Tack Endovascular System, according to a March 3 announcement from the U.S. The FDA is classifying this recall as the "most serious type," noting that the device can "cause serious injury or death."

Medical Device 130

Medical Device Healthcare Healthcare Medical 130

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 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 229

Medical Device Imaging Medical 229

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 219

Medical Device MRI Imaging Healthcare 219

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

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

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.

Medical Device 240

Medical Device Medical Healthcare Healthcare 240

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 89

Medical Device Medical IT Medical Imaging 89

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

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 288

Medical Device Government Patient Care Diagnostic Imaging 288

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 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

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

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

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

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%

X-ray 223

X-ray Medical Device Radiographer Radiographer 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 264

Imaging Image Interpretation Medical Device Radiologist 264

AuntMinnie

APRIL 30, 2024

Simply put, we cannot use large language models as a medical device,” Cozzi told AuntMinnie.com. Eventually, I am convinced we will get there. But we will need a standard, reliable development process.” Radiologists have explored the potential of large language models in interpreting mammography images.

Imaging 299

Imaging Medical Device Radiologist Clinic 299

AuntMinnie

JUNE 10, 2024

Emery has more than 30 years of experience in financial executive leadership in the pharmaceutical and medical device industries. He was previously CFO and chief operating officer (COO) at Tyber Medical. Prior to that, he led financial executive teams at Plasma Surgical and Abbott Pharmaceuticals.

Pharmaceutical 130

Pharmaceutical Medical Device Ultrasound Medical 130

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

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 162

X-ray Radiography Medical Device Medical Imaging 162

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 130

Medical Device Medical Diagnostic Hospital 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.

Medical Device 40

Medical Device Medical Healthcare Healthcare 40

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

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. It was issued following the agency's review of postmarket information and consideration of public comments.

Medical Device 130

Medical Device Medical IT Imaging 130

Imaging Technology

FEBRUARY 21, 2025

Today, healthcare providers often rely on disparate data sources, including static Electronic Medical Record (EMR) data, clinical notes and isolated device alarms.

Patient Care 52

Patient Care Medical Device Electronic Medical Record Clinic 52

Imaging Technology

DECEMBER 3, 2024

It is FDA cleared for diagnostic use and certified as a Class IIB medical device in accordance with the European Medical Device Regulation (MDR). The MedDream HTML5 zero-footprint DICOM Viewer is vendor neutral and currently integrated by more than 500 OEMs, integrators and distributors worldwide.

DICOM 52

DICOM Medical Device PACS Patient Care 52

AuntMinnie

NOVEMBER 18, 2024

Mayer is a 30-year-plus veteran in the healthcare information technology (HIT), EI, and the medical device field. "We take a collaborative approach where we review our solution offerings and hear about technologies or solutions that customers use or need. We want to share and collaborate."

Digital Imaging and Communications in Medicine 264

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