Bill of Health

FEBRUARY 8, 2022

Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. Protect Their Future created a space where doctors and parents could advocate with a unified voice. Doctors and parents used the group to collectively make public calls to agencies like the FDA and U.S. Solutions for the Future.

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HIT Consultant

MARCH 24, 2022

ActiGraft, based on RedDress’ proprietary patented technology, is an FDA-cleared wound care solution that enables health care providers to produce—in real-time—in vitro blood clots from a patient’s whole blood. The systems are expected to be delivered to Ukraine this week and could be used in the field as early as next week.

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HIT Consultant

AUGUST 31, 2021

Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ® , the world’s first and only smart knee cleared by the FDA for total knee replacement surgery. Key information (e.g.,

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Health Law Advisor

JANUARY 30, 2023

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

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Healthcare IT Today

FEBRUARY 12, 2024

As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. Visibly , a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive. Originally announced January 18th, 2024

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The Health Law Firm Blog

JULY 20, 2023

Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S. The test, made by Texas-based company, InspectIR Systems, is authorized for those [.]

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HIT Consultant

NOVEMBER 10, 2021

FDA-Clearance. Individuals can quickly become more informed and understand their heart health better — and share that information with their doctors. The result? “Withings’ approach to their ScanWatch is groundbreaking,” says Dr. Jeff Wessler, a cardiologist and Heartbeat Health’s co-founder and CEO.

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Mobi Health News

JULY 12, 2021

The sensor was designed to be used in conjunction with a corresponding app.

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Bill of Health

MARCH 7, 2024

grants doctors broad discretion to prescribe medications off-label — so if a clinician believes ketamine will alleviate a patient’s depression or anxiety, they can prescribe it relatively easily. Note: FDA approval for at least one indication is necessary for other “off-label” uses of the drug. However, the U.S.

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Health Populi

MARCH 25, 2024

The first continuous-glucose monitor that does not require a prescription was approved by the FDA on March 5, 2024. Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, asserted in the FDA approval announcement, CGMs can be a powerful tool to help monitor blood glucose. .”

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The Health Law Firm Blog

APRIL 24, 2022

Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S. The test, made by Texas-based company, InspectIR Systems, is authorized for those [.].

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Healthcare IT Today

JANUARY 24, 2024

They are still waiting on FDA clearance (like most in this space), but the concept is so simple and beautiful. Of course, these companies can’t say this is what they’re able to do until they get FDA clearance, but the early results seem promising. Here’s a look at how their demo worked for me.

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Bill of Health

JUNE 5, 2023

medical licensing exam , diagnose illnesses , and even outshine human doctors on measures of perceived empathy , raising many questions about how AI will reshape health care as we know it. Food and Drug Administration (FDA). In the field of medicine, ChatGPT already has been reported to ace the U.S.

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Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices. One such example is the Control-IQ technology , a software product recently classified by the FDA as a Class II medical device.

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HIT Consultant

SEPTEMBER 29, 2022

. – Qnovia will use the Series A proceeds to advance its NRT drug candidate through an IND submission with the FDA and begin human clinical trials in 2023. The company is currently engaged with FDA CDER to pursue a combination product authorization as the first inhalable prescription smoking cessation therapy. Prescription NRT.

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Healthcare IT Today

MARCH 29, 2024

Food and Drug Administration (FDA) to detect, outline, and quantify instances of oral disease, with millimeter-level precision. ” Without Overjet, different experts often reach different interpretations of the same dental X-ray, which can cause communication to break down between doctors, insurers, and patients.

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Healthcare IT Today

JANUARY 11, 2024

Almost all of their new devices are regulated by the FDA as medical devices. “Doctors need reassurance,” he says. .” The impact can be widespread, because only 16% of people with diabetes get their annual foot exam, but the scale can identify problems with their feet early.

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Mobi Health News

JULY 6, 2020

The new devices can link to the MyMerlinPulse app and give doctors information about a patient's heart health.

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Health Populi

JANUARY 10, 2020

Diagnostics, represented by Last Gadget Standing winner for CES 2020, MedWand — “a doctor’s visit at a patient’s fingertips” — bolstering patient engagement in-between physician visits.

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HIT Consultant

JUNE 28, 2023

OOVA is FDA-registered, HIPAA compliant, and the only test on the market to measure luteinizing hormone (LH) and progesterone (PdG) in real-time, providing women with daily insights and actionable advice to optimize their chances of conception. The average doctor’s appointment is 6.5 minutes long.

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Bill of Health

SEPTEMBER 21, 2023

Most recently, in the context of medical abortion, conservatives have tried to undermine and roll back FDA approval of mifepristone by raising concerns about whether the approval of the drug itself was based on adequate evidence.

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Healthcare IT News - Telehealth

OCTOBER 17, 2023

It’s likely the FDA will approve a new cough drug by the end of this year – the first in more than 60 years. It will empower them to better understand their disease and communicate its severity to their doctors. It will enable providers to better diagnose, select effective therapies and monitor the course of treatment.

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HIT Consultant

OCTOBER 18, 2023

. – The Series D funding will be used to support continued domestic growth and international expansion of its newly FDA approved MoMe® ARC system for virtual telemetry and remote wireless monitoring and detection of cardiac arrhythmias. MoMe® ARC is not intended for use as an emergency medical response system.

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Healthcare IT News - Telehealth

MARCH 14, 2022

The company labels Addison the next generation of remote patient monitoring technology that offers a solution to the caregiver shortage by providing healthcare management outside a doctor's four walls. Addison, to be released later this year, is a 3D-animated caregiver. " Numerous telehealth functions.

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Healthcare It News

OCTOBER 13, 2021

"That same year, FDA approved smart pills. That noise she referred to as having to know when your last colonoscopy was instead of your doctor having that at their fingertips. Records should help nurses and doctors avoid errors and suggest what treatments might be best.

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HIT Consultant

JANUARY 21, 2022

– The Series B funding will allow Casana to accelerate FDA submission of the Heart Seat with the goal to obtain FDA approval and bring this important new device to patients in 2022. The Heart Seat has already been tested through multiple peer-reviewed research studies and is currently pursuing FDA clearance.

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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

AUGUST 3, 2023

TytoCare’s Home Smart Clinic is an FDA-cleared handheld remote exam device that actually listens to your chest to better monitor asthma symptoms. The virtual care company will use this funding to advance its capabilities to manage chronic conditions. With asthma leading to 1.7 million emergency department (ED) visits, 13.8

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HIT Consultant

APRIL 10, 2024

Take Pear Therapeutics , for example, which recently went bankrupt, although its reset substance use disorder program was the first ever digital therapeutic tool to receive FDA clearance. Interoperability Doctors and nurses are busier than ever. To answer this question, it’s important to first understand what the challenges are.

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Healthcare Law Blog

AUGUST 17, 2023

FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Nearly three months after hearing oral arguments , a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v.

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Mobi Health News

JULY 6, 2020

The new devices can link to the MyMerlinPulse app and give doctors information about a patient's heart health.

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Kaiser Health News

MARCH 15, 2023

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain. The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same.

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HIT Consultant

APRIL 12, 2023

They can also then share their data with a doctor, who can confirm a diagnosis. So much so, many doctors are now “prescribing” the use of smartwatches and health apps as a way to better glean into their patient’s day-to-day health, rather than relying on stand-alone tests and routine visits.

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Bill of Health

MAY 8, 2023

After Dobbs, fertility doctors and patients have begun to realize that strict abortion laws and policies affect not only those who do not wish to continue a pregnancy, but also people who very much desire to have a child. So, states are free to decide on fetal personhood, which would have significant impacts on IVF and assisted reproduction.

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HIT Consultant

JUNE 10, 2022

In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. The FDA hasn’t just stated its willingness to collaborate with the industry.

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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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Health Populi

JANUARY 30, 2019

Most consumers would be willing to try an FDA-approved app or online to treat a medical condition, as well as receiving hospital care at home if would be less costly. This statistic also demonstrates a new tipping point and convergence between health consumers and their doctors, which has been a chasm for a while.

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