Medical Xpress

NOVEMBER 28, 2022

Using MRI data from the largest long-term study of brain development and child health in the United States, researchers have found that higher weight and body mass index (BMI) in pre-adolescence are associated with poor brain health.

Radiology 98

Radiology Development Research 98

BioTech 365

DECEMBER 1, 2020

Bayer and Blackford Analysis Announce AI Platform Agreement in Radiology Bayer and Blackford Analysis Announce AI Platform Agreement in Radiology Bayer and Blackford Analysis have entered into a development and license agreement to establish an artificial intelligence (AI) platform for … Continue reading →

Radiology 40

Radiology Licensing Licensing Development 40

pharmaphorum

SEPTEMBER 28, 2020

Housed within the agency’s Center for Devices and Radiological Health, the DHCoE is part of a wider strategy to encourage development of digital health products and therapeutics. Its remit will be to support and encourage developers, including newcomers to healthcare, to translate new technology into usable products.

Radiology 144

Radiology Production Development Regulation 144

Scienmag

NOVEMBER 30, 2021

CHICAGO – COVID-19 of mild to moderate severity in pregnant women appears to have no effect on the brain of the developing fetus, according to a study being presented today at the annual meeting of the Radiological Society of North America (RSNA). Credit: RSNA and Sophia Stöcklein, M.D.

Radiology 93

Radiology Development Medicine 93

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. About the author.

Development 105

Development Regulation Cosmetics Life Science 105

XTalks

NOVEMBER 29, 2022

The study results will be presented at the Radiological Society of North America annual meeting , which is currently being held in Chicago, IL until December 1, 2022. The Adolescent Brain Cognitive Development, or ABCD® , study is evaluating how experiences during childhood impact brain development and behavior.

Development 97

Development Radiology Clinical Trials Clinical Trials 97

Scienmag

NOVEMBER 29, 2021

CHICAGO – A small but significant percentage of college athletes with COVID-19 develop myocarditis, a potentially dangerous inflammation of the heart muscle, that can only be seen on cardiac MRI, according to a study being presented today at the annual meeting of the Radiological Society of North America (RSNA).

Radiology 75

Radiology Development 75

pharmaphorum

AUGUST 9, 2022

The software is combined with traditional MRI scanning to improve the “accuracy and speed” of prostate cancer diagnosis by improving the diagnostic resolution of images, according to the company, which makes it available as a software-as-a-service (SaaS) to radiology departments.

Radiology 83

Radiology FDA Approval Clinical Trials Clinical Trials 83

XTalks

AUGUST 18, 2022

Over the past several years, artificial intelligence (AI) tools have been developed by researchers with the goal of making cancer imaging and screening faster and more accurate, though there is still some skepticism around whether they are ready for larger-scale use in doctor’s offices. Training ProstatID to Detect Prostate Cancer.

Radiology 97

Radiology Production Scientist Development 97

FDA Law Blog

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there.

Radiology 119

Radiology Regulation Production Development 119

Medical Xpress

APRIL 19, 2023

Diagnostic imaging is indispensable in health care, as it allows clinicians to detect and diagnose a variety of medical conditions.

Development 120

Development Research Radiology 120

pharmaphorum

JANUARY 18, 2023

German pharma group Bayer has made another play in the digital medical imaging category, buying Blackford Analysis and its artificial intelligence-based platform for radiological assessments.

Radiology 59

Radiology Branding Sales Development 59

The Pharma Data

NOVEMBER 3, 2020

4, 2020 /PRNewswire/ — In its virtual booth at the 2020 Radiological Society of North America (RSNA) annual meeting, international medical imaging IT and cybersecurity company Sectra (STO: SECT B) will showcase its complete enterprise imaging offering, which empowers radiologists to accomplish more. LINKÖPING, Sweden , Nov.

Radiology 40

Radiology Cardiology Medicine Production 40

Camargo

OCTOBER 8, 2020

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. Take, for instance, an emerging biopharmaceutical company dedicated to developing novel therapies to address specialty cancers and urologic diseases. They must decide on the correct…. The Solutions. Regulatory.

Production 130

Production Drugs Development Radiology 130

WCG Clinical

JUNE 28, 2023

Princeton, NJ, June 28, 2023 — WCG, one of the world’s leading providers of solutions that measurably improve the quality, efficiency, and safety of clinical research, recently announced a partnership with Mint Medical to leverage its mint Lesion™ radiology platform for oncology trials. in New Jersey, USA.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Radiology 97

The Pharma Data

NOVEMBER 26, 2020

” The findings are scheduled for presentation at the annual meeting of the Radiological Society of North America, being held online Nov. The research was led by Eric Hoffman, a professor of radiology at the University of Iowa in Iowa City, in collaboration with Periyar Maniammai Institute of Science and Technology in Vallam, India.

Development 52

Development Radiology Research Genetics 52

pharmaphorum

JUNE 3, 2021

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. “The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” he added.

Doctors 114

Doctors Doctor Radiology Development 114

Scienmag

NOVEMBER 30, 2020

. – Researchers at Massachusetts General Hospital (MGH) have developed a deep learning model that identifies imaging biomarkers on screening mammograms to predict a patient’s risk for developing breast cancer with greater accuracy than traditional risk assessment tools.

Radiology 50

Radiology Development Research Medicine 50

pharmaphorum

OCTOBER 5, 2022

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

Antibody 110

Antibody In-Vitro Radiology Development 110

pharmaphorum

SEPTEMBER 22, 2021

. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health.

In-Vitro 108

In-Vitro Radiology Regulation Trials 108

The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.

Radiology 52

Radiology Cardiology Development Production 52

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Pregnancy : Radiation exposure during pregnancy can potentially harm the developing fetus.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

FDA Law Blog

JULY 17, 2024

Peter Marks and Patrizia Cavazzoni, spans across both Centers, and will collaborate with the Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Orphan Products Development, and Office of Combination Products. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs.

Production 105

Production Genetics Development Drugs 105

pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

Radiology 111

Radiology Marketing Genomics Genome 111

pharmaphorum

JANUARY 17, 2023

qXR has been trained on more than 2 million X-rays and their corresponding radiology reports, using deep-learning algorithms to interpret the images. A big problem is that it is frequently diagnosed at a late stage, only after symptoms like cough, breathlessness, or chest/shoulder pain develop.

Radiology 110

Radiology Pharma Companies Trials Marketing 110

The Pharma Data

NOVEMBER 3, 2020

3, 2020 — Here’s some good news for new moms: Babies born with asymptomatic brain bleeds have normal brain development by the time they reach the age of 2, researchers report. MRIs were used to examine the brains of 311 newborns in the Early Brain Development Study at the University of North Carolina between 2003 and 2016.

Radiology 52

Radiology Development Research 52

pharmaphorum

DECEMBER 15, 2022

The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. It cites data estimating there is ten-fold higher demand for radiology services than available capacity, with around half of practitioners “experiencing depression or burnout” due to “unmanageable caseloads.”

Radiology 59

Radiology FDA Approval Licensing Licensing 59

Scienmag

JANUARY 14, 2021

Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development TUCSON, Ariz., Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders, is […].

Radiology 44

Radiology Development Drugs Scientist 44

XTalks

JANUARY 26, 2024

Key breakthroughs at the forefront include novel approaches to cancer treatment and diagnosis, the integration of artificial intelligence (AI) in oncology and the development of advanced preventive measures and care. Overcoming drug resistance: A major challenge in cancer treatment is the development of resistance to chemotherapy drugs.

Research 118

Research Gene Editing Gene Genetics 118

Trialfacts

JUNE 28, 2022

Its symptoms include a lack of responsiveness to other people or activities, deficits in communication and motor skills, and overall delays in development. Participants will receive a free IQ report and radiology report at no cost. Typically Developing children aged 8-12 years old. Why Participate? Who Can Participate?

Research 52

Research Development Radiology Medicine 52

XTalks

APRIL 27, 2021

The device is called the IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) and has been developed by Neurolutions Inc. , a medical device company focused on developing neurological rehabilitation solutions leveraging patients’ own brain activity to facilitate motor recovery and restore function.

Radiology 105

Radiology Development FDA Approval Containment 105

The Pharma Data

OCTOBER 12, 2021

The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower. The LAAB was generally well permitted in the trial.

Trials 52

Trials Development Antibody Radiology 52

pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). The next steps?

Production 98

Production Regulation Manufacturing Packaging 98

XTalks

OCTOBER 26, 2022

The life cycle of a medical device encompasses several phases, initiating from the spark of a feasible idea of the device’s design, followed by an analysis of patients’ need for the plausible device, development and validation of medical device’s design, approval from the regulatory agency, a launch of the device and finally post-market research.

Production 98

Production Radiology Marketing Development 98

XTalks

SEPTEMBER 9, 2022

The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders. George, MD, distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry at the Medical University of South Carolina, in Magnus Medical’s press release.

Radiology 98

Radiology Life Science Licensing Licensing 98

pharmaphorum

FEBRUARY 3, 2021

France’s SurgAR has joined with imaging data firm Medexprim to form a three-year partnership with a major hospital in France, to develop augmented reality (AR) software dedicated to laporoscopic surgery. The information comes from preoperative radiological imaging data and aims to guide the surgeon during operations, increasing precision.

Radiology 69

Radiology Compliance Doctor Doctors 69

pharmaphorum

DECEMBER 11, 2022

It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. As we develop these technologies, it’s not only that we must focus on the patient experience; we need to start with the patient experience,” Hadjiat tells pharmaphorum.

Life Science 137

Life Science Clinical Research Development Research 137