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.

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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.

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Medical Device Medical Pharmaceutical Healthcare 59

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."

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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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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.

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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

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."

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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.

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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.

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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.

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JVIR

FEBRUARY 21, 2024

Poly-p-dioxanone (PPDO) polymers have been used to manufacture a myriad of resorbable medical devices (e.g., sutures, plates, vascular clips, stents, and IVC filters). PPDO is inherently radiolucent and may induce a pathologic inflammatory reaction that can result in neointimal hyperplasia (NH). dipyridamole, DPA).

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Imaging Technology

JUNE 19, 2024

Karamba Security’s XGuard Suite is a comprehensive set of embedded software modules designed to address the evolving cybersecurity threats faced by IoT devices, such as automotive ECUs and medical devices. on delivering a new level of security to the medical device market.” Ziehm-Orthoscan, Inc.'s

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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.

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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).

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Computed Tomography Medical Device Medical 98

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.

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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.

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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.

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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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ScienceDaily

OCTOBER 20, 2023

An international task force has laid out recommendations to ensure AI medical devices help patients and avoid worsening health inequity. Increasingly used in medicine, AI raises both hopes and concerns.

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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

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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.

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Medical Device Government Patient Care Diagnostic Imaging 115

Imaging Technology

MARCH 15, 2024

The “ Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” is meant to complement the " Artificial Intelligence and Machine Learning Software as Medical Device Action Plan ," published in January 2021. You can read the full paper here.

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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.

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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.

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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.

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Imaging Technology

OCTOBER 9, 2023

Nanovi A/S and Advaray Join CQ Medical CQ Medical also announced it has acquired medical device companies Nanovi A/S and Advaray. Nanovi A/S is a Danish medical implant company specializing in precision marking for cancer therapy. while continuing to pursue its mission of better outcomes for cancer patients.

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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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Imaging Technology

DECEMBER 20, 2023

What to Do On November 20, 2023, Philips North America LLC sent all affected customers an URGENT Medical Device Correction notice. Additional Resources: Medical Device Recall Database Entry How do I report a problem? People in the vicinity of the system when such an incident takes places.

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Magnetic Resonance Imaging Medical Device Medical MRI 105

Open Medscience

AUGUST 28, 2024

Ensuring compliance with EU MDR poses significant challenges for medical device manufacturers, including increased scrutiny, financial strain, and data protection demands. The post Ensuring Compliance: Industrial Challenges in Meeting EU MDR appeared first on Open MedScience.

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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.

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DICOM Medical Device PACS Patient Care 52

Imaging Technology

JUNE 14, 2024

milla1cf Fri, 06/14/2024 - 19:17 June 14, 2024 — Positron Corporation , a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical services, announced its membership in the national alliance “Cardiac PET Industry Coalition” (CPIC), an organization at the (..)

Computed Tomography 105

Computed Tomography Medical Device Education Healthcare 105

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 105

Imaging Medical Device Image Interpretation Radiologist 105

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 89

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.

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Medical Device Government Medical Medical Imaging 52

Open Medscience

DECEMBER 5, 2024

Medical Device Regulation ensures safety, enhances standards, fosters innovation, and supports effective healthcare delivery. The post Racing Against the Clock: Reigniting Europes Medtech Marketplace appeared first on Open MedScience.

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Medical Device Healthcare Healthcare Medical 52

Imaging Technology

JANUARY 23, 2024

syngo Virtual Cockpit is an FDA-cleared medical device not yet commercially available in all countries, and the service offering cannot be guaranteed due to regulatory or other reasons. Please contact your local Siemens Healthineers organization for further details.

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Computed Tomography Radiology Technologist Medical Device Patient Safety 110