Bill of Health

MARCH 13, 2023

The FDA’s primary responsibility is over claims that appear on product labels (including packaging, product inserts, and promotional material at the point of sale), and the FTC regulates claims made in advertising in general. FDA regulations prescribe different standards for different products and claims. million to consumers.

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

According to a 2018 report from Deloitte , the IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022. Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification.

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Health Law Advisor

JULY 11, 2023

Word Embeddings If you’re one of my three regular readers, you might remember that I’ve already introduced word embeddings I trained on FDA records. In February 2023, I wrote a post on using NLP to assess FDA’s compliance with notice and comment in guidance development. [1] I will leave you to draw your own conclusions from that.

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HIT Consultant

FEBRUARY 8, 2024

AI-Powered Clinical Trials with Digital Twins Founded in 2017, Unlearn has consistently pushed the boundaries of AI in clinical research. Their innovative technology holds immense potential to accelerate medical advancements and improve patient outcomes worldwide. founder and CEO of Unlearn.

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Bill of Health

MARCH 24, 2023

Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D. JAMA Health Forum. 2023 Feb 3;4(2):e225610. Pham C, Le K, Draves M, Seoane-Vazquez E. JAMA Intern Med. 2023 Feb 13:e226787. Epub ahead of print.

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HIT Consultant

FEBRUARY 27, 2023

Digital Automation with Radar Accuracy Founded in 2017 as a US Delaware C-Corp with international operations spanning South Korea, Canada and the United States, Xandar Kardian is led by CEO and founder Sam Yang with a mission of deploying reliable and high-accuracy cleantech, smart building and healthcare solutions worldwide.

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Healthcare It News

NOVEMBER 16, 2023

Forward Health launches staffless CarePods Forward Health, which launched its AI-driven medical concierge service in 2017, announced it will soon bring doctor-built CarePods – stand-alone medical diagnostic rooms – to major cities like San Francisco, New York and Chicago. breast screening market.

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Bill of Health

FEBRUARY 26, 2024

Much has been made of recently discussed CAR-T cell therapies for cancer , which have been around since 2017, and in-human sickle cell treatment Casgevy. In December 2022, the FDA Modernization Act 2.0 Would they classify as a medical device or biologic under FDA guidelines, or perhaps as a combination product?

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Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

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HIT Consultant

OCTOBER 9, 2022

– The multi-center study evaluated the FDA-cleared EyeArt AI system against dilated eye exams performed by general ophthalmologists and retina specialists on the same cohort of 521 study participants. The study design was a prospective, pivotal, multi-center trial conducted from April 2017 to May 2018. Participants were ?18

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Mobi Health News

JANUARY 10, 2019

In December 2017, the company’s assay FoundationOne CDx received approval from the US Food and Drug Administration (FDA). The company develops, manufactures, and sells genomic profiling assays based on next-generation sequencing technology for solid tumours, hematologic malignancies, and sarcomas.

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Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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HIT Consultant

SEPTEMBER 27, 2023

Industry leaders, IEEE SA members, and the FDA are all working together to create accuracy standards for this innovative technology. Once cleared by the FDA, these medical devices will be Class 2 software as medical device technology. December 13, 2017. Int J Clin Pract. 2020; 75:e13664.

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Health Law Advisor

APRIL 5, 2022

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. of that guidance, and FDA refers to these as “concurrent.”

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HIT Consultant

MARCH 9, 2022

Founded in 2017, MediView uses augmented reality to provide surgeons with intraoperative 3D “x-ray” holographic visualization. – The XR90 Augmented Reality Surgical Navigation System , MediView’s flagship product, is slated for FDA submission in the second half of 2022. Healthcare Metaverse Has Arrived.

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Healthcare IT News - Telehealth

MAY 9, 2022

Between 2017 and 2020, 113 women died from pregnancy-related causes, while 177 deaths during that period were deemed to be "pregnancy-associated." In December 2021, the FDA opted to permanently modify its regulations, thereby enabling abortion via telehealth in more than half the country. " Black women were 2.5

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Health Law Advisor

JUNE 1, 2022

Most companies want to avoid FDA warning letters. To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that FDA issues. How does FDA define the terms used in this part? Background.

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Healthcare IT Today

FEBRUARY 29, 2024

Founded in 2017 as an AI research company, Unlearn has always been at the forefront of developing innovative AI-based solutions for clinical trials. Their methods using participants’ digital twins are qualified by the European Medicines Agency and align with current FDA guidance. For more information, please visit unlearn.ai

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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. million units with revenues of $4.5 billion.

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Mobi Health News

MAY 25, 2018

Dexcom started out the year strong following the FDA clearance of its integrated continuous glucose monitor the G6. In its Q1 earnings call, the company reported a 30 percent increase in revenue compared to Q1 of 2017, bringing its total revenue to $184 million.

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HIT Consultant

OCTOBER 16, 2023

How Ozempic Works: The Basics Ozempic is a weekly injection containing the active ingredient semaglutide, FDA-approved in 2017 for adults with Type 2 diabetes. While Ozempic is not yet FDA-approved specifically for weight loss, some medical professionals are considering its “off-label” use as a weight-loss solution.

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HIT Consultant

JUNE 28, 2023

Founded in 2017, Gleamer’s suite of AI-powered solutions supports radiologists and clinicians in their diagnoses, thereby improving reliability and reducing the time taken to read and process examinations.

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Healthcare It News

OCTOBER 13, 2021

"In 2017, gene therapy was used to cure a teenage boy of sickle cell disease," he said. "That same year, FDA approved smart pills. "In the five years since I last talked at CHC, there have been some amazing medical breakthroughs," said Feinberg in his virtual keynote address.

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HIT Consultant

OCTOBER 14, 2022

Obatala Sciences, a New Orleans biotechnology company, was founded in 2017 to enable diversity in clinical research and speed up the development of better therapies for diseases like obesity, diabetes, and cancer, and advance research in tissue engineering and regenerative medicine.

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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.

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Health Populi

OCTOBER 8, 2021

Even so, 2 in 3 adults said they would likely get an app to track a medical condition that was approved by the FDA. The phrase “concerned embrace” was coined in a 2017 Deloitte consumer study on mobile technology trends. FDA clearance makes a difference in peoples’ trust with health apps, with 2 in 3 U.S.

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HIT Consultant

OCTOBER 17, 2021

Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. FDA website, March 27, 2018. FDA website, December 8, 2017.

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Health Populi

NOVEMBER 8, 2018

substantially grew between 2012 and 2017, many more women than men use these holistic medicine approaches. In 2017, 14.3% Headspace is a well-adopted app for meditation, getting traction in healthcare with research partners at Carnegie Mellon, Harvard, and Kaiser Permanente who are studying the app to collect data for FDA scrutiny.

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SQA

AUGUST 2, 2021

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process. ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

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NY Health Law

JULY 9, 2019

More than 70% of CBD extracts sold online, for instance, were mislabeled regarding potency, according to a Penn Medicine study in 2017. The FDA is struggling to determine how to regulate CBD. The FDA is also gathering data from the public through the use of a docket that is open for comment until July 16, 2019.

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Dot Compliance

FEBRUARY 1, 2022

Food and Drug Administration (FDA) recently issued pharma industry guidance documents that will impact how companies collect, manage and submit quality data to the agency. Data in the regulatory spotlight. Here are two points worth noting as we head into the new year. Data is the name of the game in 2022 and beyond. References. References.

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Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

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Dot Compliance

FEBRUARY 8, 2022

Regulatory bodies, namely the FDA and IMDRF, have issued regulations that apply to given software applications used on mobile applications and general-purpose platforms alike. However, ongoing innovations create new challenges on a regular basis for developers.

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HIT Consultant

FEBRUARY 3, 2023

Figure 1: Summary of Digital Pathology VC Investment from 2017-2022. Certainly, investment in the market has slowed since, as there has been no funding recently raised that’s comparable to PathAI or Paige.ai’s 2021 rounds, which both received over $100M respectively.

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Health Populi

MAY 30, 2018

This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. The team analyzed data-sharing guidelines across 230 policy documents published between 1996 and 2017. into the precision medicine category. Note that autonomy and privacy rank with the most mentions.

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Health Populi

OCTOBER 6, 2021

That post was written in tandem of CES 2017 when I did a deep dive into the potential for autos to bolster wellness and promote safety and hygiene (well pre-COVID).

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HIT Consultant

MAY 31, 2023

Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production. million Americans.

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