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.

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XTalks

MAY 21, 2024

Device and Radiological Health Innovations In October 2023, the FDA’s Center for Devices and Radiological Health has celebrated a decade of the Early Feasibility Studies (EFS) Program.

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Clinical Trials Clinical Trials Trials Clinical Research 64

XTalks

JUNE 30, 2023

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, head of Radiology Research and Development at Bayer, in the company’s news release. “We

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The Pharma Data

OCTOBER 1, 2021

Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. About Radiology at Bayer Everyone deserves clear answers about their health, starting with an early and accurate diagnosis. Currently, the quality dose for all marketed GBCAs, including gadobutrol and gadoterate, is 0.1 mmol/kg weight. “At

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Radiology Life Science Development Production 52

XTalks

JANUARY 26, 2024

Through the end of July 2023, 79 percent of such devices FDA-authorized in 2023 are in radiology, nine percent in cardiovascular, five percent in neurology, four percent in gastroenterology/urology, two percent in anesthesiology and one percent each in ear, nose and throat (ENT) and ophthalmic.

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XTalks

MARCH 27, 2023

The primary endpoints were global cure (consisting of clinical cure, radiological cure and mycological eradication) at 14 days for the European Medical Agency (EMA), and a 30-day all-cause mortality for the US FDA. Rezafungin met the endpoints outlined by both the EMA and FDA.

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Clinical Trials Clinical Trials Branding Trials 98

XTalks

APRIL 7, 2021

The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.”.

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XTalks

JULY 13, 2022

“The work conducted in collaboration with the leadership at the FDA’s Center for Devices and Radiological Health facilitated the development of AI innovation that will now deliver better digital health to the American public. . “Healthy.io in the company’s press release.

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Reagent In-Vitro Radiology Life Science 98

The Pharma Data

NOVEMBER 19, 2020

Hojvat served as the director of the Division of Microbiology Devices at the Center for Devices and Radiological Health at the Food and Drug Administration for 12 years. Additionally, the company appointed Sally Hojvat, as a regulatory strategy advisor. Source link.

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Life Science Research Development Radiology 52

XTalks

JULY 10, 2024

Unlike traditional testing methods that require samples to be sent to central laboratories, this test utilizes a blood sample from the fingertip to detect HCV RNA, delivering results in approximately one hour.

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RNA In-Vitro Genotype Marketing 97

XTalks

OCTOBER 1, 2024

GE HealthCare’s newly US Food and Drug Administration (FDA)- approved flurpiridaz F 18 positron emission tomography (PET) radiotracer, Flyrcado, could offer a new approach to diagnosing coronary artery disease (CAD).

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XTalks

MARCH 10, 2021

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a press announcement from the agency.

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pharmaphorum

MARCH 11, 2021

Estimates of medical diagnostics worth to the UK vary – MedTech Europe puts its value at around £1billion while the Office for Life Sciences reported in 2018 that it accounts for around 27% of the £24 billion turnover generated annually by the UK’s medtech sector.

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In-Vitro Containment Radiology Life Science 72

XTalks

JANUARY 19, 2024

Advantages of Alpha Emitter Therapy Over the past two decades, the radiological and chemical properties of alpha emitting isotopes have regained prominence in medical physics.

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DNA Radiology FDA Approval Development 66

Delveinsight

SEPTEMBER 2, 2021

The BD Veritor At-Home COVID-19 Test is an easy-to-use test with definitive digital results, ideal for use in the home, as said by Dave Hickey, president of Life Sciences for BD. The rise in COVID-19 cases from the Delta variant has raised the requirement for at-home testing.

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Marketing Radiology Drugs Drug Delivery 72

XTalks

AUGUST 30, 2022

The Neurology and Radiology departments are vital for consultation and imaging, which is needed to establish baselines for a study. According to Carter, it is valuable to have dedicated neurosurgical, radiology and departmental staff for the surgery, MRI and other imaging techniques done at the clinical trial site.

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Trials Drug Delivery Drugs Gene 83

XTalks

NOVEMBER 7, 2022

Prospective clinical trials are needed to explore whether changing therapy based on ctDNA dynamics prior to radiologic or clinical progression will improve outcomes compared to our current standard,” added Dr. Bahassi. There is a high risk of false positives and false negatives (variant allele frequencies [VAFs] at frequencies <0.5

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

MAY 13, 2022

The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case. Devices, combo products, SUS: for a medical device or combination product, one should leverage ISO 10993, specifically, Parts 17 and 18. The approaches have key differences in study design such as number of replicates required (i.e.

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The Pharma Data

DECEMBER 23, 2020

Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA). It will be funded by the U.S.

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XTalks

JUNE 12, 2023

Siemens Healthineers further demonstrated its commitment to innovation at the European Congress of Radiology in Vienna, showcasing its revamped Acuson ultrasound portfolio. Numerous partnerships with hospitals and other medtech companies were also announced.

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Intouch Solutions

SEPTEMBER 27, 2024

With our dedicated Oncology Center of Excellence , we provide access to a team of industry-leading experts across various commercial service lines who combine their in-depth understanding of the market with strategic insights to enable EVERSANA to consistently deliver exceptional results for life sciences companies.

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DNA Trials Antibody Marketing 59

pharmaphorum

MARCH 16, 2021

There are a good number of use cases as to why pretty much every big life science company is choosing us these days,” says Medrano. Life sciences companies are interested in understanding the behaviour of the patients and the pathologies where they are working. AI use in the pandemic.

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XTalks

SEPTEMBER 11, 2024

In 2016, the FDA’s Center for Devices and Radiological Health (CDRH) established the Health of Women Program to study issues related to the performance of medical devices in women, highlighting the necessity of gender-specific data.

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Clinical Trials Clinical Trials Trials Hormones 103

XTalks

SEPTEMBER 14, 2020

Drugs and Vaccines. Two new phase III clinical trials will be initiated shortly to evaluate the safety and efficacy of remdesivir, a nucleotide analog with broad-spectrum antiviral activity, in adults diagnosed with COVID-19.

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Vaccination Vaccine Antibody Life Science 92