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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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.

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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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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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FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. One cause of death in this “valley” is related to the need to understand and meet regulator expectations. By Adrienne R. Food & Drug Admin.,

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. In effect, these documents serve as road signs helping to direct new market entrants. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process.

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XTalks

APRIL 6, 2021

Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators. 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.

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FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

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FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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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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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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FDA Law Blog

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”.

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The Pharma Data

APRIL 20, 2022

director of the FDA’s Center for Devices and Radiological Health. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. Source link: [link].

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XTalks

JUNE 12, 2023

Medtronic’s Hugo Robotic-Assisted Surgery system , released in a limited market in June 2021, has been receiving positive reviews for its performance in various surgeries. Medtronic is optimistic about this opportunity and anticipates high demand across a large global market. billion in 2022, an increase of 1.36 percent from $27.06

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The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. had demonstrated respectable results.

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The Pharma Data

OCTOBER 14, 2020

The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”. market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years.

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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. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

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XTalks

AUGUST 30, 2022

CNS drugs take more than a year longer to develop and are less than half as likely to receive marketing approval compared to other drugs, according to a 2014 study by the Tufts Center for the Study of Drug Development. Why is it Difficult to Develop CNS Therapeutics?

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XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

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The Pharma Data

MAY 3, 2021

Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ). Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market ( Endpoints ).

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XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Here again, the stock markets are functioning in a parallel universe. billion in June. ECONOMIC IMPACT: Canada.

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FDA Law Blog

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. Gibbs — On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr.,

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FDA Law Blog

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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