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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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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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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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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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.

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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

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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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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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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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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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.

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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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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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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

JUNE 6, 2024

Radiology informatics firm aycan has inked a reseller and technology partnership with AI4MedImaging, a company that specializes in applying AI to medical imaging. Aycan said it plans to resell future products from AI4MedImaging and work with the company to integrate its AI technology into other partner solutions.

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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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AuntMinnie

MAY 29, 2024

The end-to-end care continuum is designed to support clinicians and promote developments for lung health in the pharmaceutical and medical device industries. will unveil its lung care continuum at the ASCO annual meeting. It features AI tools that identify, measure, manage, and monitor lung health developments.

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AuntMinnie

MAY 15, 2024

Siemens Healthineers company Varian will distribute medical device company Innova Vascular's Laguna Thrombectomy System for treating venous thromboembolism.

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MedImaging MRI

SEPTEMBER 13, 2023

A robotic guidance and placement system that can operate within an MRI bore could find various applications, including biopsies, treatment administration, and medical device placement.

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MedImaging Ultrasound

MARCH 1, 2024

Researchers are studying how the use of ultrasound medical devices can reduce reliance on nasopharyngoscopy and prevent harm in patients undergoing neck surgery.

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AuntMinnie

APRIL 25, 2024

Italian medical device vendor Esaote posted increased revenues for fiscal year 2023, citing upticks in sales in its ultrasound and MRI segments. Financial results for the company's full fiscal year (end-December 31) showed revenues of 273.2 million euros ($292 million), up 6.5% over fiscal year 2022.

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AuntMinnie

JUNE 8, 2023

Medical device developer Teleflex has received U.S. Food and Drug Administratio. Read more on AuntMinnie.com Related Reading: Teleflex, FundamentalVR to collaborate Teleflex gets nod from FDA

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AuntMinnie

JUNE 20, 2024

Polarean Imaging , a commercial-stage medical device developer for lung MRI, has closed a $12.6 million financing round through the Alternative Investment Market (AIM) of the London Stock Exchange. The funding was co-led by Nukem Isotopes GmbH and Bracco S.p.A., in addition to support from other existing and new investors.

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AuntMinnie

AUGUST 1, 2023

secures EU medical device regulation certification Read more on AuntMinnie.com Related Reading: Qure.ai wins Japan QuickFire challenge Qure.ai joins forces with Nuance Medtronic and Qure.ai partner to advance AI stroke management Qure.ai, Therapixel enter into distribution partnership Qure.ai

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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 (..)

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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

JULY 18, 2023

Read more on AuntMinnie.com Related Reading: MITA praises FDA for Leqembi approval MITA chides CMS on beta-amyloid PET decision Groups urge CMS to rethink projected cuts for imaging payments MITA applauds FDA for AI medical device principles MITA takes aim at CMS proposal to limit Alzheimer's drug coverage

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AuntMinnie

NOVEMBER 15, 2023

Butterfly launched Butterfly Garden in August to facilitate partnerships with medical device companies, AI companies, or software developers who want to build new applications with Butterfly's imaging platform.

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Imaging Technology

JUNE 18, 2024

milla1cf Tue, 06/18/2024 - 20:02 June 18, 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, is pleased to welcome a prominent cardiovascular practice in Michigan as a new customer utilizing Positron’s Attrius (..)

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AuntMinnie

APRIL 19, 2023

secures EU medical device regulation certification Qure.ai Artificial intelligence (AI) software developer Qure.ai has joined Nuance Communication'. Read more on AuntMinnie.com Related Reading: Nuance releases new AI healthcare documentation app Qure.ai secures FDA clearance for qER-Quant

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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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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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AuntMinnie

JANUARY 11, 2024

Food and Drug Administration (FDA) 510(k) medical device clearance. Cleerly is launching its Cleerly Ischemia software, which recently received U.S. The software is an automated machine learning-based decision support tool.

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AuntMinnie

JANUARY 4, 2024

Together, Deep 6 AI and Graticule are using AI and natural language processing to mine large, real-time pools of structured and unstructured electronic medical record (EMR) data, such as clinical notes, imaging data and radiology reports, and catheterization lab reports.

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AuntMinnie

MAY 21, 2024

GE HealthCare topped a list of AI-enabled medical devices to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) this year, at 72.

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