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 87

Medical Device Medical IT Medical Imaging 87

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

Health Imaging

AUGUST 26, 2024

The FDA’s current draft guidance on the approval process for AI devices does not specify the type of validation the agency recommends manufacturers use.

Medical Device 128

Medical Device Medical 128

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

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).

Medical Device 40

Medical Device Medical 40

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 99

Medical Device MRI Diagnostic Medical 99

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 105

Medical Device Imaging X-ray Clinic 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.

Medical Device 52

Medical Device Medical PACS 52

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 113

Medical Device Radiology Medical 113

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.

Medical Device 102

Medical Device Medical IT 102

Open Medscience

OCTOBER 19, 2024

Cybersecurity in medicine is essential for protecting patient data, medical devices, and healthcare systems from cyberattacks. The post Cybersecurity in Medicine: Battling Critical Healthcare Threats appeared first on Open MedScience.

Healthcare 52

Healthcare Healthcare Medical Device Medical 52

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

Medical Device 105

Medical Device Quality and Compliance Medical IT 105

AuntMinnie

NOVEMBER 13, 2024

His prior experience spans investment banking, management consulting, and extensive partnering work at large medical device and biopharmaceutical companies, including Medtronic, Smith & Nephew, and Mallinckrodt Pharmaceuticals, Lumicell noted.

Pharmaceutical 52

Pharmaceutical Medical Device Medical Imaging 52

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 52

Medical Device Government Medical Medical Imaging 52

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 96

Hospital Medical Device Imaging Medical 96

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 105

Medical Medical Device 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 52

MRI Medical Device Diagnostic Medical 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 97

Medical Device Radiology Medicare Healthcare 97

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 96

Medical Device Medical Healthcare Healthcare 96

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 52

Pharmaceutical Medical Device Ultrasound Medical 52

AuntMinnie

OCTOBER 28, 2024

AI developer HeartLung Technologies has received breakthrough medical device designation and marketing authorization from the U.S. Food and Drug Administration (FDA) for its Automated Cardiac Chambers Volumetry (AutoChamber) software.

Medical Device 52

Medical Device Disease Medical IT 52

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.

Medical Device 111

Medical Device Imaging Medical Patient Care 111

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 98

Medical Device Hospital Medical IT 98

AuntMinnie

OCTOBER 24, 2024

already has a Medical Device License in Canada and is under review by the U.S. offers automation of the image processing steps, which the company said can lead to a reduction in operator time without compromising the accuracy of the measurements. Food and Drug Administration.

Ultrasound 52

Ultrasound Medical Device Diagnostic Medical 52

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).

Computed Tomography 97

Computed Tomography Medical Device Medical 97

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.

Medical Device 82

Medical Device Medical 82

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.

Medical Device 105

Medical Device Imaging MRI Patient Care 105

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 52

Medical Device Medical IT Imaging 52

AuntMinnie

FEBRUARY 1, 2024

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

Medical Device 52

Medical Device Government Patient Care 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 64

X-ray Radiography Medical Device Medical Imaging 64

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.

Medical Device 104

Medical Device Hospital Medical Clinic 104

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 111

Radiologist Medical Device Education Medical 111

AuntMinnie

AUGUST 28, 2024

AI medical device developer Imidex and DNA sequencing technology company Orbit Genomics have established a partnership to develop a combined approach for diagnosing lung cancer. The companies are preparing to start clinical trials.

X-ray 52

X-ray Medical Device Diagnose Clinic 52

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.

MRI 52

MRI Medical Device Medical 52

AuntMinnie

MAY 15, 2024

Health Canada has issued a medical device license to KA Imaging for its Reveal Mobi Pro x-ray system. Reveal Mobi Pro is a dual-energy mobile x-ray scanner that integrates KA Imaging’s Reveal 35C detector with SpectralDR technology into a complete system.

X-ray 52

X-ray Medical Device Imaging Medical 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 115

Medical Device Government Patient Care Diagnostic Imaging 115

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

Medical Device 52

Medical Device Medical 52