HIT Consultant

NOVEMBER 4, 2024

Food and Drug Administration (FDA), the trial aims to assess the system’s safety and effectiveness in achieving procedural success with minimal complications. Conducted under an Investigational Device Exemption (IDE) granted by the U.S.

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HIT Consultant

APRIL 12, 2022

What You Should Know: – Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally. – The algorithm will soon be available to users in the U.S. Why It Matters.

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Bill of Health

NOVEMBER 17, 2022

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. Limitations on the Capability of the FDA to Advise.

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Healthcare It News

NOVEMBER 16, 2023

" Aoun said when he founded Forward Health that he was focused on AI that can predict adverse health events. " FDA clears Lunit breast cancer screening algorithm Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, announced Tuesday that the U.S.

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Healthcare IT Today

DECEMBER 22, 2024

It’s initially being used in Stelo, Dexcom’s FDA-cleared over-the-counter glucose biosensor. Company News Cellular blood pressure monitor BPM Pro 2 from Withings Health Solutions received FDA clearance. Dexcom launched a proprietary generative AI platform build on Google Cloud. People NCQA Founder and President Margaret E.

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Healthcare IT Today

DECEMBER 6, 2024

Healthcare IT Today once again attended the annual RSNA conference in Chicago, IL and once again the event was filled with interesting sessions and innovations. about getting FDA clearance for applying AI in healthcare. It was no surprise that AI utter dominated the discussions and the booths.

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Mobi Health News

AUGUST 23, 2018

Online patient community PatientsLikeMe, which connects patients with different symptoms and conditions and collects patients' voluntarily submitted data for research, has teamed up with the FDA on a research study that could point the way toward a new channel for patient-generated health data for the agency.

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Healthcare IT Today

MARCH 28, 2025

The company has already received 12 FDA clearances, and one of its CT Brain algorithms has FDA Breakthrough Device Designation and Medicare reimbursement through the New Technology Add-on Payment (NTAP). Further accelerating its global commercialization efforts, Harrison.ai is establishing a North American presence in Boston.

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Compliancy Group

NOVEMBER 4, 2024

One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health.

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Healthcare IT News - Telehealth

JANUARY 22, 2021

For reimbursement by the CMS, a device must be an FDA-listed device. However, an FDA approval ensures a medical device is safe and effective for its intended use. FDA classifies medical devices into three classes based on risk to human life.

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Kaiser Health News

OCTOBER 7, 2024

senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices. . The FDA’s response was modest.

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HIT Consultant

MARCH 6, 2025

Comprehensive Patient Support and Insights StrivePD Guardian is a subscription-based service that combines human support with the latest Large Language Model (LLM) technology, utilizing patient data collected via StrivePD and FDA-cleared Apple Watch monitoring.

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Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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Bill of Health

NOVEMBER 18, 2022

The book explains that despite these events, DEG adulteration continues due to regulatory failures. India has had at least five major cases of DEG poisoning in the past. Most recently, in 2020, 11 children in India died of DEG poisoning. This is only one example of the deep rot within the system.

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Healthcare IT News - Telehealth

MARCH 15, 2023

FDA clears AI-driven remote wheeze detection by TytoCare TytoCare, a virtual care company, announced today that it has received U.S The company's FDA-approved handheld remote examination device and AI analyze recorded lung sounds to help clinicians diagnose respiratory conditions remotely.

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Bill of Health

APRIL 28, 2023

What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners and associates at top health care law firms all have in common? The Petrie-Flom Center Student Fellowship !

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American Medical Compliance

MAY 7, 2024

The following FDA Report for Safer Medical Products for Healthcare Providers educates healthcare providers (HCP) on how to report medical device malfunctions, serious injuries, or deaths associated with medical devices to the FDA. Additionally, complaint files are linked to MDR event files.

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Total Medical Compliance Resources

JANUARY 16, 2025

Sterilizer use As with any method of sterilization, always use FDA approved devices and closely follow manufacturers instructions for proper use. Liquid chemical sterilant Lastly, an alternative sterilization process for heat sensitive items is utilizing a liquid chemical sterilant cleared by the FDA.

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Healthcare IT News - Telehealth

MARCH 14, 2022

The bundle includes the VIVE Flow immersive glasses, preloaded with XRHealth FDA-registered medical applications, and includes a screening video call with an XRHealth clinician. An inside look at the innovation, education, technology, networking and key events at the HIMSS22 Global Conference & Exhibition in Orlando.

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HIT Consultant

FEBRUARY 19, 2023

Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), now expect PROs to be included in study protocols, objectives and even labeling claims. The FDA has identified 5 core aspects of the patient experience to consider throughout the development of an eCOA: 1.

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HIT Consultant

MAY 31, 2022

What You Should Know: – Akili’s EndeavorRx , the first and only FDA-cleared video game ADHD treatment for kids, is uniting with Roblox’s global virtual universes forming a first-of-its-kind partnership. . No serious adverse events were associated with its use.

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Healthcare IT News - Telehealth

MAY 6, 2020

Biovitals’ AI-based treatment algorithms then enable software-based therapeutic interventions that signal to clinicians what they should do next to intervene, in order to prevent critical events that would otherwise lead to hospitalizations or visits to the emergency department. iRhythm Technologies.

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Healthcare IT Today

FEBRUARY 18, 2025

This article is a roundup of interesting stories, product announcements, partnerships, research studies, and sales from this year’s event in Nashville. Aidoc received FDA clearance for computer-aided triage for rib fractures. Welcome to the special ViVE 2025 edition of Healthcare IT Today Bonus Features.

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McGuire Wood

OCTOBER 12, 2023

Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety requirements for medical devices. To strengthen the QSR metrics, the FDA recommends implementing a secure product development framework (SPDF) to address cybersecurity risks. 27, 2023, the U.S.

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HIT Consultant

NOVEMBER 11, 2024

To gauge the magnitude of this trend, consider this: as of August 7, 2024, 950 AI/ML-enabled medical devices have received clearance from the FDA , with 76% of these designed for radiology. 723 radiological AI-powered tools have been FDA-cleared to this day, and the number keeps growing by 100 every year!

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HIT Consultant

MAY 17, 2024

What You Should Know: – Implicity , a leader in remote patient monitoring and cardiac data management, has received FDA 510(k) clearance for SignalHF1 , a groundbreaking new algorithm within their remote monitoring solution. Making a Difference for All Patients SignalHF1 stands out for its versatility.

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Healthcare IT Today

JANUARY 24, 2024

This year that growth was particularly true thanks to the great efforts of Catherine Pugh who put together an entire Digital Health track, a long list of digital health vendors, and a packed house digital health networking event. They are still waiting on FDA clearance (like most in this space), but the concept is so simple and beautiful.

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Bill of Health

NOVEMBER 4, 2022

EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. At a minimum, IRBs should determine if the proposed data collection/sharing, above and beyond that pertaining to serious adverse events, is voluntary. Part 3: What’s an IRB to do?

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HIT Consultant

MARCH 6, 2024

This influx of capital marks a pivotal moment in BHT’s mission to reshape bone health for postmenopausal women, closing right in time for de novo FDA clearance. Osteoboost stands out as the premier non-pharmacological FDA-cleared prescription device tailored to address this lucrative $30 billion market.

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Mobi Health News

MARCH 21, 2022

The device, which is not yet cleared by the FDA, alerts bystanders to a potential cardiac event nearby and guides them to the scene.

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Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. Complaint Investigation/Adverse Events 3. NDA/Adverse Event Report 7. FOI Services submitted a lot of requests, but their success rate was proportionately not as good as FDA News, for example.

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HIT Consultant

SEPTEMBER 26, 2024

Food and Drug Administration (FDA) has recently emphasized the importance of assessing genomic integrity, including the detection of chromosomal abnormalities such as copy number variations (CNVs), to ensure clinical safety.

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Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. Complaint Investigation/Adverse Events 3. NDA/Adverse Event Report 7.

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Health Law Advisor

MAY 19, 2022

In September 2021, the Food and Drug Administration (FDA) issued and updated a consumer advisory outlining consumer safety concerns related to delta-8 products. The Centers for Disease Control and Prevention issued similar guidance warning consumers of the rise in hospitalization reports and adverse event incidents related to delta-8 THC.

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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

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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

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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