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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HIT Consultant

NOVEMBER 16, 2022

– Dr. Taraman served as the company’s Chief Medical Officer since 2017, leading clinical evidence generation and regulatory milestones of Canvas Dx and those resulting in FDA Breakthrough Device Designation of Cognoa’s autism digital therapeutic.

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FDA 95

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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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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Regulatory Compliance FDA Health Outcomes Compliance 97

HIT Consultant

OCTOBER 30, 2024

Recently, the company received FDA clearance for an Early Feasibility Study (EFS) in the US, and patient enrollment is actively ongoing with the first US patients already treated. The funds raised will be used to advance clinical trials and expand regulatory approvals in the US and Europe.

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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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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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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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HIT Consultant

JULY 15, 2024

Innovalve’s Pioneering Mitral Valve Technology Founded in 2017 at ARC Innovation, Innovalve has been at the forefront of developing a minimally invasive approach to mitral valve replacement. The technology has already received FDA approval for initial human trials, with over 40 successful surgeries performed to date.

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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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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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FDA 57

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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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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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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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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Healthcare IT Today

OCTOBER 23, 2023

The Athelas garage 2016, And first office in 2017 (pre-FDA clearance) Originally announced October 4th, 2023 We’re here for the long haul to build an enduring, genre-defining healthcare company using software, sensors, and artificial intelligence.

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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 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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SQA

OCTOBER 18, 2024

The EC engaged Gesundheit Österreich GmbH (Austrian National Public Health Institute), Civic Consulting, and Areté to collect data on the availability of medical devices in the EU and the progression of transitions to the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

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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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HIT Consultant

JULY 11, 2024

Food and Drug Administration (FDA). In 2017, the regulator warned the radio-frequency-enabled devices manufactured by St. However, as of 2023, the FDA orders they meet specific security guidelines — patches must be available periodically and in emergencies, and manufacturers must submit a software bill of materials.

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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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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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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 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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COVID-19 Vaccine FDA Pharmaceutical Industry COVID-19 52

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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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

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

JANUARY 31, 2018

In 2017, Hugh Langley wrote in Wareable that, “blood pressure is wearable tech’s next challenge.” Omron is submitting the HeartGuide watch for FDA review this year and once cleared, the device will be the first blood pressure monitor that accurately reads BP right from the wrist.

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Pharmacy Law Blog

MARCH 13, 2018

On December 4, 2017, a Florida federal judge refused to dismiss the federal government’s False Claims Act (FCA) suit against a compounding pharmacy. December 4, 2017). December 4, 2017). By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law. To read the court’s order in full, click here. Raymond, Nate.

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Dot Compliance

JANUARY 14, 2022

EU MDR 2017/745. The European Union Medical Device Regulation (Regulation (EU) 2017/745, MDR) establishes the restrictions and requirements on the manufacturing and design of medical devices. FDA’s Safer Technologies Program (SteP) for Medical Devices. Source: [link]. Source: [link].

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