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.

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Pharmaceutical Technology

NOVEMBER 30, 2022

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Vaccine 147

Vaccine Vaccination Development Gene Therapy 147

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

Roots Analysis

MAY 3, 2022

Blue ocean strategy, a concept first introduced in 2004, by W Chan Kim, and Renee Mauborgne in their bestselling book of the same name, talks about how to achieve a breakthrough in a highly saturated market by focusing on creating a new uncontested market. One of the thirteen strategic tools is strategy canvas. LinkedIn: [link].

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Marketing Radiology Drugs 52

pharmaphorum

OCTOBER 20, 2020

Demand for telehealth solutions like tele-ICU, tele-radiology, tele-pathology, to help virtual working of care professionals also drove growth in Q3. Frans van Houten also teased Philips’ financial 2021-2025 targets which will be released in full at its Capital Markets Day on 6 November.

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Sales Radiology Medicine Production 105

Camargo

OCTOBER 8, 2020

While the sponsor initially planned to approach the Center for Radiological Health (CDRH), it soon became apparent that the combination product should be submitted to the Center for Drug Evaluation and Research (CDER). Camargo provided support by planning the key sections of the TPP to align sponsor goals, patient needs, and product labeling.

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Production Drugs Development Radiology 130

pharmaphorum

APRIL 16, 2021

It’s been working closely with Microsoft since 2019, and its main products – including Dragon Ambient eXperience (DAX), Dragon Medical One and PowerScribe One for radiology reporting – are all built on Microsoft’s Azure cloud platform. History in the making!

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Radiology Doctor Doctors Production 92

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. have been working together since 2022, through the pharma group’s Emerging Markets Health Innovation Hubs programme. ” AZ and Qure.ai

Radiology 110

Radiology Pharma Companies Trials Marketing 110

BioTech 365

SEPTEMBER 2, 2020

NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, … Continue reading → SOUTH JORDAN, Utah, Sept.

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Radiology Cardiology Manufacturing Marketing 40

The Pharma Data

FEBRUARY 21, 2022

Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.

Radiology 52

Radiology Cardiology Development Production 52

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). North America dominated the market in 2018 with a 47.46 percent share.

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RNA In-Vitro Genotype Marketing 97

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.

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Production Radiology Marketing Development 98

FDA Law Blog

MAY 22, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications.

Radiology 59

Radiology Regulation Marketing 59

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 9, 2022

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. SAINT is not the only neurostimulation system for depression to be recently cleared by the FDA.

Radiology 98

Radiology Life Science Licensing Licensing 98

The Pharma Data

OCTOBER 26, 2020

With this new joint venture, to be known as Arizona Diagnostic Radiology Group, RadNet has established an operating platform in the Phoenix metropolitan area, a rapidly growing market and home to almost five million people. RadNet’s core markets include California, Maryland, Delaware, New Jersey, New York, and now Arizona.

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Radiology Marketing Development Medicine 40

Delveinsight

JANUARY 14, 2021

Other Hallux Valgus marketed devices includes Lapidus Plating System (LPSTM) , which is approved for the correction of mild to extreme forefoot H.V., Besides Treace, Wright Medical Technology is also a major contender in the Hallux Valgus market. Hallux Valgus market for years now. subsequent bunions and related instability.

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Marketing Radiology Development Production 40

The Pharma Data

SEPTEMBER 30, 2021

Food and Drug Administration authorized marketing of software to help medical professionals who examine body tissues (pathologists) within the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue faraway from the body). Today, the U.S.

Radiology 52

Radiology In-Vitro Marketing Drugs 52

FDA Law Blog

FEBRUARY 20, 2023

GoodRx has an estimated market capitalization of over $2 billion dollars. Through our FDA-focused lens, we see a possible roadmap as FDA’s Center for Devices and Radiological Health (CDRH) increases its resources, guidances, and enforcement emphases in the connected digital device space. The penalty of $1.5 million is, well, not a lot.

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Radiology Regulation Compliance Marketing 105

XTalks

APRIL 27, 2021

The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older.

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Radiology Development FDA Approval Containment 105

XTalks

APRIL 7, 2021

The new, revised EUA will allow the company to market the test for the qualitative detection of SARS-CoV-2 from nasal swab samples for screening use with serial testing. The EUA allows for the marketing of the device in the US.

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Antibody Immune Response Radiology Marketing 102

The Pharma Data

SEPTEMBER 16, 2020

The move is intended to increase flexibility for health labs to make tests available through the market. These claims were dismissed by HHS Chief of Staff Brian Harrison, who said that: “Every interaction between the secretary and commissioner has been highly professional.”. Matt Fellows. Source link.

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Radiology Marketing Development Medicine 52

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

Pharma Packaging Solutions

OCTOBER 29, 2024

Navigating the Regulatory Landscape In the United States, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) lays down strict regulations that govern medical device packaging. Essential Packaging Requirements Examining the arena of packaging requirements reveals many considerations.

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Packaging Packaging Regulation Pharma Packaging 52

The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. ,

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Marketing Production Radiology Cosmetics 40

FDA Law Blog

AUGUST 18, 2024

In effect, these documents serve as road signs helping to direct new market entrants. Sponsors of a new 510(k) device can use the decision summary and classification order affiliated with the De Novo to learn what the De Novo applicant submitted and build the case for substantial equivalence to the De Novo device.

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In-Vitro Radiology Cosmetics Medicine 69

XTalks

FEBRUARY 10, 2021

The US Food and Drug Administration (FDA) has granted marketing authorization to Signifier Medical Technologies ’ sleep apnea treatment device, called eXciteOSA. The new device is designed to reduce snoring and treat mild obstructive sleep apnea (OSA) in individuals 18 years and older, and is available by prescription only. How it Works.

Radiology 97

Radiology Marketing Clinical Trials Clinical Trials 97

The Pharma Data

OCTOBER 19, 2020

Adventist Health is pleased to partner with RadNet, the nation’s leading outpatient radiology provider. RadNet’s core markets include California, Maryland, Delaware, New Jersey, New York, and now Arizona. RadNet, Inc. RadNet has a network of 332 owned and/or operated outpatient imaging centers.

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Radiology Production Marketing 40

Worldwide Clinical Trials

JULY 8, 2024

Similar to the FDA, the EMA evaluates radiopharmaceuticals for safety, efficacy, quality, and GMP regulation compliance before granting marketing authorization. International Commission on Radiological Protection (ICRP) The ICRP provides recommendations and guidance on radiation protection standards for occupational and public exposure.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

XTalks

APRIL 19, 2024

Both tools represent Avicenna.AI’s focus on developing tools that integrate AI within the radiology workflow, improving the speed and accuracy of medical diagnostics. According to GlobalData , the global AI in healthcare market was valued at $81.3 AI in medical imaging is a large segment driving the market. percent and 24.2

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Marketing Radiology Development Manufacturing 52

The Pharma Data

OCTOBER 1, 2021

Currently, the quality dose for all marketed GBCAs, including gadobutrol and gadoterate, is 0.1 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. mmol/kg weight. “At

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Radiology Life Science Development Production 52

The Pharma Data

MARCH 24, 2021

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. JPEO-CBRND.

Vaccine 52

Vaccine Vaccination Radiology Trials 52

XTalks

APRIL 6, 2021

It was approved under the Premarket Approval (PMA) pathway, which is the most stringent type of device marketing application required by the FDA. The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98

Delveinsight

DECEMBER 29, 2020

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist.

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Trials Drugs Hormones Radiology 52

Delveinsight

SEPTEMBER 2, 2021

This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.

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Marketing Radiology Drugs Drug Delivery 72

The Pharma Data

DECEMBER 14, 2020

Program grants are awarded to companies with promising technologies that have a strong potential for commercialization, to help translate life-saving innovations to consumer markets and create jobs in biotechnology. About Alume Biosciences, Inc. ————-. This award was granted by the National Institutes of Health.

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Clinical Trials Clinical Trials Trials Radiology 52

pharmaphorum

MARCH 16, 2022

In the pharmaceutical industry digital marketing is nothing new, but in the context of onsite-and-online events it is. That said, the industry has accrued substantial experience of virtual engagement with healthcare professionals dating back for at least 25 years. Will it focus more on onsite, more on online, or on both options equally?

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Doctors Doctor Marketing Radiology 98