FDA Law Blog

FEBRUARY 15, 2023

Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well. Thus, these regulations apply to a huge variety of products.

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FDA Law Blog

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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XTalks

AUGUST 18, 2022

ProstatID is available in the form of software as a service (SaaS) and is both HIPAA-compliant and secure as its use requires a secure VPN connection between a radiology department’s server or MRI system and the cloud-hosted ProstatID server. XTALKS WEBINAR: Accelerate Product Approval Using In Silico Modeling & Simulation.

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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.

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pharmaphorum

MAY 18, 2022

.” He was also involved in the creation of the FDA’s Digital Health Center of Excellence in 2020 and drawing up the Center for Devices and Radiological Health (CDRH) 2022-2025 strategic priorities, which covers much of the agency’s digital health plans.

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pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. New SaMD guidance and more.

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The Pharma Data

NOVEMBER 2, 2020

3, 2020 /PRNewswire/ — The sites at the first two local health districts in NSW Health Care are now live with international medical imaging IT and cybersecurity company Sectra’s (STO: SECT B) radiology imaging solution. Together, they perform more than 400,000 radiology examinations per year. LINKÖPING, Sweden , Nov.

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Pharmaceutical Technology

NOVEMBER 30, 2022

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. The University of Texas Medical Branch (UTMB) and HDT Bio have received a funding worth up to $87.4m

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pharmaphorum

OCTOBER 20, 2020

Philips said it had ramped up production of the equipment to meet global demand. Demand for telehealth solutions like tele-ICU, tele-radiology, tele-pathology, to help virtual working of care professionals also drove growth in Q3. The Dutch health technology group reported sales of €4.98bn, a 10% year-over-year growth.

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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.

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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.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations.

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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.

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BioTech 365

OCTOBER 27, 2020

Distribution Center to support the ongoing growth of Bayer’s Radiology global business that supplies medical device products … Continue reading →

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pharmaphorum

OCTOBER 5, 2022

This extended area, beyond prevention of influenza illness, will potentially be for supportive medical countermeasures for up to 10 “other pathogens of pandemic potential”, whether they be “chemical, biological, radiological [or] nuclear”.

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pharmaphorum

SEPTEMBER 8, 2022

As yet, no new medical product has been approved on the basis of a digital endpoint. It is hoped today’s event will serve as a “blueprint for the broader development and deployment of digital endpoints in medical product development”.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. shaking, changes in pressure, etc.).

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The Pharma Data

NOVEMBER 30, 2020

The radiology module will be used throughout the hospital and be part of a regional collaboration network initiative in the Limburg area. With this solution, Jessa Hospital anticipates increased radiology productivity across the region for the benefit of patient outcomes. LINKOPING, Sweden , Dec.

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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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Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. Ensure your products meet regulatory standards while making patient safety and efficacy top priorities.

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Worldwide Clinical Trials

JULY 8, 2024

It also oversees Good Manufacturing Practices (GMP) for radiopharmaceutical production facilities to ensure consistent quality and safety standards. European Medicines Agency (EMA) The EMA regulates radiopharmaceuticals within the European Union (EU) through its Committee for Medicinal Products for Human Use (CHMP).

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FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

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FDA Law Blog

NOVEMBER 5, 2023

Notably, Dr. Won’s career path included a tenure at FDA’s Center for Devices and Radiological Health (CDRH), Division of Dental and ENT Devices within the Office of Product Evaluation and Quality.

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FDA Law Blog

AUGUST 18, 2024

De Novos now play an important role in product advancement. By taking the simple step of making summaries available faster, FDA can facilitate the clearance of new products, and make life easier for its own reviewers. Of course, Congress had created the problem in the first instance.)

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XTalks

SEPTEMBER 5, 2024

The trials, published in Radiology , involved 44 patients and 49 tumors — ranging from primary liver cancers to metastatic tumors. HistoSonics announced the results of its pivotal #HOPE4LIVER trials, showcasing the Edison Histotripsy System’s effectiveness in non-invasively destroying liver tumors.

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pharmaphorum

AUGUST 4, 2020

to just under €4 billion, “weighed down” by COVID-19 and China’s new volume-based procurement policy for healthcare products. Group sales were down 2.5% to just over €10 billion, with pharma falling 8.8% Shares in Bayer were on the slide in mid-morning trading after the figures were announced, down a little over 3%.

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The Pharma Data

APRIL 15, 2022

director of the FDA’s Center for Devices and Radiological Health. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month. ###. for the next public health emergency.”. The FDA, an agency within the U.S. Source link: [link].

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The Pharma Data

OCTOBER 19, 2020

Adventist Health is pleased to partner with RadNet, the nation’s leading outpatient radiology provider. In addition, RadNet provides radiology information technology solutions, teleradiology professional services and other related products and services to customers in the diagnostic imaging industry.

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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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FDA Law Blog

NOVEMBER 21, 2022

CDRH Launches the Total Product Life Cycle Advisory Program Pilot (Oct. Total Product Life Cycle Advisory Program (TAP) (Oct. Devices regulated by the Center for Biologics Evaluation and Research (CBER) and combination products are outside the scope of the TAP Pilot. Food & Drug Admin., Food & Drug Admin.,

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XTalks

MARCH 10, 2021

The products encompass molecular, antigen and T cell-based testing approaches. 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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The Pharma Data

DECEMBER 10, 2020

. “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in an agency news release. © 2020 HealthDay. All rights reserved. Posted: December 2020.

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XTalks

MARCH 27, 2023

The antifungal drug was approved under Priority Review based on its Qualified Infection Disease Product designation , an incentive to promote development of antifungals for life-threatening infections. Candidemia is a bloodstream infection caused by the Candida yeast and is a common form of invasive candidiasis.

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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.

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XTalks

JUNE 12, 2023

In Medtronic’s annual report, CEO Geoff Martha attributes their success in this area to their comprehensive suite of products and solutions, which equip clinicians with the tools necessary for optimal atrial fibrillation care. It also plans to launch these products in the US. On May 25, 2022, Medtronic and DaVita Inc.

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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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XTalks

OCTOBER 1, 2024

These products exemplify the company’s ongoing efforts to advance molecular imaging. Recently, Lumicell’s imaging platform received dual FDA approval for its Lumisight optical imaging agent and Lumicell Direct Visualization System (DVS), further showcasing advancements in imaging technologies across different cancer indications.

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