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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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

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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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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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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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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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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4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients

HIT Consultant

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.

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Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

HIT Consultant

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 Digital Health Atrial Fibrillation FDA FDA Clearance Fitbit Heart risk

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RapidAI Receives FDA 510(k) Clearance for Pulmonary Embolism Triage & Notification

HIT Consultant

Digital Health AI Artificial Intelligence care teams Clinical Decision Support decision support FDA Patient Care physicians

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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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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

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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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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FDA Releases Updated Guidance on Medical Device Cybersecurity

HIPAA Journal

Food and Drug Administration (FDA) has issued new draft guidance for medical device manufacturers to help them incorporate cybersecurity protections into their products at the premarket stage, and to ensure security risks are managed for the full life cycle of the products. The U.S.


FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

Healthcare Dive

The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use. A CDC panel is meeting Friday and Saturday to develop specific recommendations

FDA releases medical device cybersecurity draft guidance

Healthcare IT News - Telehealth

"These recommendations can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats," said FDA in the Federal Register notice about the guidance. The U.S.

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First COVID-19 Breathalyzer Test Authorized By FDA

The Health Law Firm Blog

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., M.P.A., 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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'Where's the patient?': Experts question FDA's final recall guidance

Healthcare Dive

While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system

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FDA must improve medical device interoperability through data standards: JAMA

Healthcare Dive

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case

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Are Essential Oils FDA-Approved?

Florida Health Care Law Firm

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. List of FDA-Approved Essential Oils. Updating Your Essential Oil Marketing to Be Compliant With FTC & FDA Standards.

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RedDress Donates FDA-Cleared Wound Care Solution to Aid Injured Ukrainians

HIT Consultant

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. Digital Health Most Popular FDA Heal video wound care

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FDA grappling with influx of illegal COVID-19 tests entering US

Healthcare Dive

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge

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Califf confirmed as FDA chief in close vote, ending protracted vacancy

Healthcare Dive

Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close

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FDA's OTC hearing aid proposal exposes industry, stakeholder rifts

Healthcare Dive

Different manufacturers have lined up on opposite sides of a debate about key aspects of the agency's proposed rule that would create a new category of over-the-counter hearing aids

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FDA clears second COVID booster for older adults, immunocompromised

Healthcare Dive

Citing "some waning of protection over time," the agency authorized another dose of either Pfizer's or Moderna's shots for adults aged 50 years or older as well as for people with weakened immune systems

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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Collectively, these guidances cover a range of digital health issues, and it is worth reading FDA Commissioner Scott Gottlieb’s statement about them as well as each individual document: Clinical and Patient Decision Support Software (CDS and PDS) (Draft). Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA Selects Aetion Evidence Platform to Assess In-Patient COVID-19 Treatments

HIT Consultant

Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD. Digital Health Life Sciences Aetion Coronavirus (COVID-19) FDA

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Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Healthcare Dive

Bristol Myers paid $13 billion to acquire the drug's maker, MyoKardia, and expects it to become a blockbuster. But a tricky dosing regimen, as well as safety concerns, could challenge the pharmaceutical giant's lofty forecast

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GE Healthcare gets FDA nod for software that automates anesthesia delivery

Fierce Healthcare

GE Healthcare gets FDA nod for software that automates anesthesia delivery. agliadkovskaya. Tue, 04/05/2022 - 18:37

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FDA releases guidance for remotely acquiring data in clinical investigations

Healthcare IT News - Telehealth

"Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection," said FDA officials. "It does not establish any rights for any person and is not binding on FDA or the public."

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Moderna seeks FDA clearance for COVID-19 vaccine in young children

Healthcare Dive

The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination

Google hires former FDA digital health officer to global strategy post

Healthcare Dive

In his new role, Bakul Patel will help Google build a unified digital health and regulatory strategy

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FDA advisers back Novavax COVID-19 shots as new U.S. option

Modern Healthcare

FDA's vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves

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Google Health hires FDA's former digital health chief to lead global strategy

Fierce Healthcare

Google Health hires FDA's former digital health chief to lead global strategy. hlandi. Mon, 05/16/2022 - 15:00

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FDA Finalizes Guidance on Combination Products

C&M Health Law

Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website.

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FDA Approves Use Of AI Tool Predicting Adverse Events In ICU

Healthcare IT Today

The FDA has agreed to a special authorization allowing a vendor to deploy its AI tool designed to predict adverse events in hospital ICUs.

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Pear's VR product for postoperative pain granted FDA STeP designation

Healthcare Dive

The agency's designation under the Safer Technologies Program for medical devices could expedite regulatory review for the virtual reality-based digital therapeutic, one of several products in Pear's pipeline

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FDA advisers grapple with how to update COVID-19 vaccines

Healthcare Dive

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach

Aidoc software receives FDA green light for flagging, triaging brain aneurysms

Mobi Health News

This marks Aidoc's second FDA 510(k) so far this year

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AppliedVR Awarded FDA Approval for VR Therapeutic for Lower Back Pain

HIT Consultant

Food and Drug Administration (FDA) has granted de novo approval for its flagship immersive therapeutic, EaseVRx, to treat chronic low back pain, which previously received breakthrough device designation in 2020. Digital Health Startups AppliedVR FDA Therapeutic Virtual Reality Virtual Realit

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FDA halts Vir, GSK antibody use in response to COVID subvariant's spread

Healthcare Dive

The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however

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