Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Healthcare IT Today

JANUARY 8, 2024

It maintains the most rigorous security certifications and holds over 100 patents and numerous regulatory registrations, including FDA clearance and CE marking. About Lunit Founded in 2013, Lunit is a deep learning-based medical AI company on a mission to conquer cancer. For more information, visit volparahealth.com.

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Health Populi

AUGUST 12, 2021

In this Rise of the Medical Machines, the major risks for health care organizations were that, 68% of health care deployments had more than 10 FDA recalls. . “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis.

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HIT Consultant

FEBRUARY 10, 2023

FDA-Cleared AI-Guided Ultrasound Technology Founded in 2013, Caption Health delivers AI systems that empower healthcare providers with new capabilities to acquire and interpret ultrasound exams. In addition, it aligns with strategy to deliver precision care and expands access to new ultrasound users and clinical uses.

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Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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The Health Law Firm

MAY 14, 2013

On May 8, 2013, the US Food and Drug Administration (FDA) sent a warning to doctors and pharmacists to avoid drugs made by The Compounding Shop, based in St. Click here to read the press release from the FDA. There’s been yet another recall from a compounding pharmacy. Petersburg, Florida.

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Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. In the post last month, I looked at response times in general.

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The Health Law Firm

MARCH 20, 2013

On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. Click here to read the FDA communication.

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Healthcare IT Today

FEBRUARY 27, 2024

HealthBeacon was founded in 2013 in Dublin, Ireland. The product is patent protected, FDA cleared, and FSA, HSA, Medicare, and Medicaid eligible. Postal Service’s approved mail-back program. HealthBeacon also provides a digital risk management platform for prescribing restricted medication to oncology patients.

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Hall Render

MAY 11, 2022

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). Accordingly, FDA is proposing the withdrawal and replacement of the current 21 C.F.R.

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Healthcare IT Today

NOVEMBER 9, 2023

HIPAA was last revised in 2013. Imagine if a small manufacturer of new medical devices had to get approval to market its device in each state, instead of just with the FDA. At the same time, the ATA is worried about state-level legislation. Principles Concerning AI Zebley says that the AI team is very bullish on the potential of AI.

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Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. 1, 2021). [2]

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Bill of Health

FEBRUARY 16, 2022

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes.

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The Health Law Firm

OCTOBER 21, 2013

Board Certified by The Florida Bar in Health Law On September 20, 2013, the US Food and Drug Administration (FDA) announced that companies will have to include unique device identification (UDI) codes on medical devices. The UDIs will be entered into a public database that the FDA will maintain. Indest III, J.D.,

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SQA

MAY 17, 2022

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. United States Food and Drug Administration (FDA) – Regulations and Guidances. United States Food and Drug Administration (FDA) – Recalls.

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The Health Law Firm

MAY 28, 2013

The US Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. To read the press release from the FDA, click here.

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The Health Law Firm

JANUARY 31, 2013

A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category of controlled substances. According to a number of different sources, on January 25, 2013, the committee presented this recommendation to the FDA.

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The Health Law Firm

APRIL 24, 2013

A Lake Mary, Florida, compounding pharmacy recently recalled products due to concerns from the Food and Drug Administration (FDA). announced a voluntary recall of all lots of its sterile unexpired ophthalmic products on April 17, 2013. Click here to read the press release from Balanced Solutions on the recall.

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HIT Consultant

AUGUST 1, 2024

Clearly, the use of AI in medical imaging alone has grown exponentially, with nearly 700 FDA-approved AI algorithms across a variety of healthcare specialties as of the end of 2023 (up from just 50 in 2013). 171 of these were approved between October 2022 and October 2023 alone.

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Kaiser Health News

OCTOBER 7, 2024

han presionado a la Administración de Drogas y Alimentos (FDA) para que tome medidas que ayuden a eliminar la desviación racial en los oxímetros de pulso. Pero mientras la FDA trabajaba en un borrador de directrices, los médicos y los científicos no saben a qué atenerse.

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Healthcare IT Today

JUNE 13, 2024

About Lunit Founded in 2013, Lunit is a medical AI company on a mission to conquer cancer. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,000 hospitals and medical institutions across 40+ countries.

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The Health Law Firm

MARCH 28, 2013

On March 19, 2013, the Supreme Court justices discussed whether makers of generic drugs already approved by the Food and Drug Administration (FDA) can be held liable under state law for claims of design defects. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law.

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Kaiser Health News

MARCH 15, 2023

But she said nothing worked as well as methadone, an opioid she has taken since 2013. The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. She hopes her current doctor won’t do the same.

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Exeed Regulatory Compliance

JULY 31, 2020

In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease. If the answer is yes, then FDA may not issue an EUA. You can also watch a brief video about this process below.

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Verisys

JULY 8, 2024

Enacted in 2013, the DSCSA mandates the implementation of an interoperable electronic system to trace prescription drugs from manufacturers to dispensers. During this period, the FDA will not enforce certain DSCSA requirements to help ensure a smooth transition. What is DSCSA?

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Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. Not to spill the beans, but if you think that, you’d be wrong.

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Natalia Mazina

JUNE 26, 2023

The Drug Supply Chain Security Act (“DSCSA”) was enacted in 2013 with the goal of creating an interoperable electronic system to trace certain prescription drugs as they are distributed in the United States. The Act sets six compliance deadlines. The last one is coming up on November 27, 2023 and pertains to enhanced product tracing.

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Florida Health Care Law Firm

MARCH 22, 2022

To satisfy the requirements that FDA convene and consult an advisory committee as discussed above, in July 2000, the Pharmacy Compounding Advisory Committee (“PCAC”) provided FDA with advice with respect to developing a list of difficult to compound drugs. More discussions between the PCAC and FDA occurred over the next few years.

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Healthcare IT Today

AUGUST 15, 2023

The company has built a comprehensive portfolio of stroke solutions, including Rapid NCCT Stroke – the first and only FDA-cleared medical device to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from non-contrast CT imaging. The company is also developing additional modules for other disease states.

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HIT Consultant

APRIL 5, 2023

Leading the Way Forward in Delivering and Distributing Medical Imaging Founded in 2016 by Dr. Greg Kolovich, a Harvard-trained, board-certified orthopedic surgeon, and serial entrepreneur Evan Ruff, OXOS Medical launched its first FDA-approved device, the Micro C®, in 2022. The demand for radiology services has steadily risen since 2013.

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HIT Consultant

MAY 30, 2024

To protect this system against potential threats and the illegal movement of counterfeit drugs, the Drug Supply Chain Security Act (DSCSA) was enacted in 2013. Presently, we are in a “stabilization period” where the FDA is temporarily exercising enforcement discretion for specific requirements of the DSCSA.

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Pharmacy Law Blog

MARCH 13, 2018

The relator McKenzie Stepe, a former RS sales representative, originally filed her complaint in December 2013. The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits.

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AIHC

JANUARY 28, 2022

This includes two technologies under the alternative pathway for new medical devices that are part of the FDA Breakthrough Devices Program and five technologies approved under the alternative pathway for products that received FDA Qualified Infectious Disease Product (QIDP) designation. billion in FY 2021, or 2.7 percent.

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Hall Render

JANUARY 3, 2024

from the University of Michigan Law School in 2013. office and helps clients navigate the complex and ever-changing landscape of FDA regulation. From vendor contracting to distribution, Liza advises clients on sourcing and procurement strategies that aim to mitigate risks, create efficiencies and reduce operational costs.

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Health Populi

NOVEMBER 3, 2021

Kinsa Health began to market the first FDA-cleared smartphone-connected thermometer in 2013. One terrific example that clearly illustrates the opportunity to address these three pillars is the Kinsa Health School Program, described in the report.

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Health Blawg

APRIL 30, 2018

The company supports provider organizations participating in the BPCI program , having gone live in Fall 2013. The FDA is interested in the platform as well, for post-market surveillance applications. The company supports provider organizations participating in the BPCI program, having gone live in Fall 2013.

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