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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Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. But if they say that their product is FDA-approved to do something specific, that is incorrect and they are open to fines and could be shut down.

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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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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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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Compensation and medical treatment in event of injury. On August 15, 2023, the U.S.

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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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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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Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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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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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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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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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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HIT Consultant

AUGUST 2, 2023

The pathway will augment Geisinger’s existing remote heart failure management program by incorporating the FDA-cleared Bodyport Cardiac Scale and Fluid Alerts. Together, Geisinger and Bodypart will develop and implement a fluid-guided care pathway for heart failure.

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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

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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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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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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Health Law Advisor

JULY 5, 2022

To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device. The root cause that is labeled “PMA” means that the product had no FDA approval.

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HIT Consultant

JULY 5, 2022

With the lack of flow between devices, it is hard for a clinician to uncover why a medical event may happen. Once an adverse medical event happens, it can potentially cause life-altering implications to a patient.

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Health Law Advisor

JANUARY 13, 2022

In 2021, the FDA approved the first anti-amyloid monoclonal antibody drug, Aduhelm, which is intended to trigger a response by the patient’s own immune system that destroys the accumulation of amyloid plaques. The FDA’s determination does not mandate Medicare coverage for Aduhelm. What Happens Next?

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Bill of Health

FEBRUARY 27, 2024

There is a common and problematic misconception that colonization was an isolated historical event and that the present is somehow divorced from its precedent. Let’s consider a foundational event in modern psychedelic history: the introduction of psilocybin mushrooms into Western society by Drs.

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MedTrainer

FEBRUARY 19, 2024

Exposure incidents: Unanticipated events that involve contact with blood or other bodily fluids that can potentially cause harm. Sentinel events: Result in severe or permanent harm or death. Incident reporting has led to several FDA recalls in the past, with some including breast implants, insulin pumps, and defibrillators.

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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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Healthcare IT Today

AUGUST 11, 2022

In fact, more than half of all patients who experience a heart attack show no symptoms before their potentially catastrophic event. These surrogates too often fail patients as predictors and miss the majority of patients who will suffer a heart attack. About Cleerly. Cleerly is the company creating a new standard of care for heart disease.

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HIT Consultant

MARCH 10, 2022

Sepsis occurs when the immune system reacts abnormally to an infection, setting off a chain of events that leads to tissue damage and organ failure. Prenosis is currently seeking to obtain FDA clearance for the tool by the end of 2022. “Personalized medicine is the next frontier of healthcare.

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Dot Compliance

NOVEMBER 21, 2022

The purpose of medical device quality management systems (QMS) is to make it easier to adhere to FDA requirements and standards like ISO 13485. Businesses trying to promote their life science products are always up against FDA regulations. The FDA’s regulatory requirements must be met for your product to be approved for sale.

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Health Law Advisor

AUGUST 1, 2023

Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. To tie the MDR data with the recall data, we are using K numbers, the numbers that FDA assigns during the course of a 510(k) review.

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HIT Consultant

APRIL 28, 2022

EnsoData increases sleep lab capacity and efficiency with their FDA-approved sleep study analysis platform, EnsoSleep. Further, EnsoSleep analyzes sleep test waveform data to provide accurate sleep staging and event detection for clinician review.

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HIT Consultant

AUGUST 24, 2022

It is the only provider of cloud-based insulin management software across the continuum of care, and Glytec’s FDA-cleared titration software and proprietary algorithms power the only solution capable of delivering personalized diabetes treatment recommendations from hospital to home.

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Compliancy Group

NOVEMBER 2, 2022

The Food and Drug Administration (FDA) recognized this when they released guidance for medical device manufacturers to increase cybersecurity. Medical device manufacturers must submit a ‘Cybersecurity Bill of Materials’ during premarket reviews to the FDA for review. Asset Management.

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MedTrainer

JANUARY 12, 2024

Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products. Office of Inspector General (OIG): This independent agency within the U.S. Department of Health and Human Services focuses on preventing fraud, abuse, and waste in federal healthcare programs.

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Bill of Health

APRIL 26, 2022

This event was sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and is part of the Center’s Project on Psychedelics Law and Regulation (POPLAR). A full video of the event is available below.

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HIT Consultant

NOVEMBER 30, 2021

Labcorp plans to offer this service in over 1,000 locations by mid-December – better preparing the communities it serves to be able to return to the office, attend social events and celebrate the holidays with confirmation of a virus-free status prior to participating. Labcorp became the first U.S.

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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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Dot Compliance

APRIL 14, 2023

In the past, a specific series of events led to the machinery’s failure. The AI application detects that these events are happening again, makes the correlation, and alerts the system user to this trend. This individual can intervene to prevent a production disruption or the risk that poor-quality products are produced.

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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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MedTrainer

JULY 12, 2023

It’s used to track, analyze, and resolve various types of incidents, including medical errors, adverse events, patient safety issues, equipment failures, security breaches, and other incidents. Incident management software enables organizations to streamline the reporting process for incidents, accidents, near misses, and other safety events.

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