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Pig Hearts for Humans and the FDA

Bill of Health

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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Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

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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Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

Bill of Health

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 issues first EUA for monkeypox test

Healthcare Dive

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 advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Healthcare Dive

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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TytoCare Receives FDA Clearance for AI-Powered Tyto Insights for Wheeze Detection

HIT Consultant

– 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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Clarius Awarded FDA Clearance for AI Ultrasound Musculoskeletal Imaging App

HIT Consultant

“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 Introduces Dietary Supplement Ingredient Directory

Health Law Advisor

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 approves Narcan for over-the-counter use

Healthcare Dive

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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Dexcom Receives FDA Clearance for G7 Continuous Glucose Monitoring (CGM) System

HIT Consultant

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 panel approves path toward one-shot yearly COVID vaccine

Fierce Healthcare

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

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FDA warns about unauthorized versions of rapid COVID-19 tests from 3 manufacturers

Healthcare Dive

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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FDA’s Cybersecurity Modernization Action Plan

HealthIT Answers

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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Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

Bill of Health

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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FDA Cybersecurity Requirements for Medical Devices Now in Effect

HIPAA Journal

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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FDA digital health chief talks new role with agency, AI tech

Healthcare Dive

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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Medical Devices Cleared or Approved by FDA in 2022

HIT Consultant

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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Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

HIT Consultant

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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Unpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database

Health Law Advisor

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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Biotricity Awarded FDA 510(k) Clearance for Cardiac Monitoring Device

HIT Consultant

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 details plan to end emergency use authorizations

Healthcare Dive

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 approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

Healthcare Dive

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 clarifies cybersecurity recommendations for device makers in new guidance

Healthcare Dive

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 takes N95 respirators off medical device shortage list

Healthcare Dive

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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FDA warns of cyber vulnerabilities in medical device software components

Healthcare Dive

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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Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids

Healthcare Dive

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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FDA rule allows retail pharmacies to dispense abortion pills

Fierce Healthcare

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

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

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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Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

Healthcare Dive

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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RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage

HIT Consultant

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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Cardiologs Awarded FDA Clearance for Pediatric Use of Algorithm

HIT Consultant

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 clears Novavax's COVID-19 vaccine as 4th option in US

Healthcare Dive

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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5 FDA decisions to watch in the second quarter

Healthcare Dive

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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Unpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment

Health Law Advisor

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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Selux Receives FDA Clearance for its Rapid Antibiotic Susceptibility Test (AST) System

HIT Consultant

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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