Bill of Health

APRIL 14, 2022

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. In 2016, the FDA updated previously existing guidance for xenotransplantation. Xenotransplantation Products at the FDA. By Jacob Balamut.

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FDA Public Health Licensing 305

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. By Cathy Zhang.

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Bill of Health

NOVEMBER 9, 2022

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug.

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FDA Bioethics 254

Healthcare Dive

SEPTEMBER 8, 2022

Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests

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FDA 222

Healthcare Dive

JUNE 15, 2022

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision

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HIT Consultant

MARCH 15, 2023

– TytoCare , a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US.

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HIT Consultant

FEBRUARY 5, 2023

“AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound. Digital Health mHealth AI Artificial Intelligence Color FDA FDA Clearance mobile health model Patient Care Ultrasound

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FDA 73

Health Law Advisor

MARCH 14, 2023

Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.”

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FDA 52

Healthcare Dive

MARCH 30, 2023

It’s the first time a naloxone-based therapy for opioid overdoses has been cleared for use without a prescription, potentially helping to improve access

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HIT Consultant

DECEMBER 8, 2022

What You Should Know: – The FDA has cleared Dexcom G7 continuous glucose monitoring (CGM) system in the U.S. Digital Health Health IT apple Apple Watch Dexcom diabetes Diabetes Management digital health Digital Health Apps FDA FDA Clearance insulin Wearables

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FDA 80

Fierce Healthcare

JANUARY 27, 2023

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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FDA 119

Healthcare Dive

MARCH 3, 2022

But the FDA has learned some unauthorized versions of their diagnostics have entered the country The manufacturers have all received emergency use authorizations for antigen tests.

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HealthIT Answers

DECEMBER 6, 2022

The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. The post FDA’s Cybersecurity Modernization Action Plan appeared first on Health IT Answers.

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Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. By Matthew Chun.

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HIPAA Journal

MARCH 30, 2023

Food and Drug Administration (FDA) will not authorize their use. In a guidance document for FDA staff, the FDA said it does not intend to issue refuse to accept (RTA) decisions for premarket submissions that fail to include the required information on cybersecurity until after October 1, 2023.

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Healthcare Dive

FEBRUARY 17, 2022

Bakul Patel, the Center for Devices and Radiological Health's chief digital health officer, will help FDA meet its 2022-2025 strategic priorities and set regulatory policies for the new technologies such as AI and machine learning

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HIT Consultant

AUGUST 29, 2022

In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Here’s a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some of these new FDA medical devices will truly impress you.

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HIT Consultant

APRIL 8, 2022

What You Should Know: – Arterys , the world’s leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.

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Health Law Advisor

DECEMBER 6, 2022

I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same. For context, I should explain that I didn’t set out to find differences in the FDA data sets.

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FDA 98

HIT Consultant

JANUARY 24, 2022

Food and Drug Administration (FDA) for its Biotres Cardiac Monitoring Device, a three-lead device for ECG and arrhythmia monitoring that is intended for lower-risk patients. Digital Health biotricity Cardiac Monitoring FDA FDA clearance 510k

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FDA 95

Healthcare Dive

MARCH 24, 2023

The agency is providing a 180-day transition period for devices that were exempted during the pandemic, and said companies that currently have an EUA should start preparing

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FDA 130

Healthcare Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety

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FDA 300

Healthcare Dive

APRIL 8, 2022

The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions

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FDA 281

Healthcare Dive

AUGUST 30, 2022

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said

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Healthcare Dive

MARCH 10, 2022

An agency alert warned that flaws in PTC's Axeda agent and desktop server, used in devices from several manufacturers, could allow an unauthorized attacker to take full control of the host operating system

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FDA 276

Healthcare Dive

FEBRUARY 2, 2022

The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5

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Fierce Healthcare

JANUARY 4, 2023

FDA rule allows retail pharmacies to dispense abortion pills. fdiamond. Wed, 01/04/2023 - 08:12

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. By allowing retail sales of affordable hearing aids, the FDA regulations go a long way in helping consumers address this challenge yet could result in risk to health plans.

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FDA Fraud Licensing Medicare 88

Healthcare Dive

JUNE 16, 2022

With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects

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FDA 242

HIT Consultant

JULY 21, 2022

What You Should Know: – RapidAI , the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity , the newest addition to the RapidAI platform.

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HIT Consultant

NOVEMBER 23, 2021

What You Should Know: Cardiologs announced today that the FDA has cleared their algorithm to be used for the pediatric population – younger than 18. Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for pediatric cardiology.

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FDA 84

Healthcare Dive

JULY 13, 2022

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron

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COVID-19 Vaccine FDA COVID-19 230

Healthcare Dive

APRIL 4, 2022

Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs

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FDA 253

Health Law Advisor

JANUARY 3, 2023

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. Product codes are the language of FDA regulation.

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FDA Medical Device Industry 98

HIT Consultant

JANUARY 20, 2023

What You Should Know: – Selux Diagnostics has been granted 510(k) clearance from the US FDA for its Next Generation Phenotyping (NGP) System — a rapid antibiotic susceptibility (AST) testing platform able to determine a bacteria’s susceptibility to a specific panel of antimicrobial agents.

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FDA 52