Healthcare Dive

SEPTEMBER 8, 2022

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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Healthcare IT Today

SEPTEMBER 20, 2024

The following is a guest article by Jay Nakashima, President at eHealth Exchange An FDA project aims to make it as easy as possible for clinicians to report adverse drug events and share important clinical data with public health agencies to investigate the event.

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HIT Consultant

NOVEMBER 14, 2024

What You Should Know: – GE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS, a 3.0T SIGNA MAGNUS: Advancing Neuroimaging with Cutting-Edge MRI Technology The FDA clearance of the SIGNA MAGNUS by GE HealthCare marks a significant leap forward in neuroimaging technology.

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Fierce Healthcare

AUGUST 8, 2024

Big Health, a maker of digital treatments for mental health, has clinched Food & Drug Administration (FDA) clearance of its product for insomnia, Fierce Healthcare has learned in an a | SleepioRx, its flagship digital therapeutic, is intended for the treatment of chronic insomnia and insomnia disorder as an adjunct to usual care in adults over (..)

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Healthcare Dive

FEBRUARY 17, 2022

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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Healthcare Dive

JUNE 15, 2022

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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Healthcare Dive

MARCH 3, 2022

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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HIT Consultant

OCTOBER 13, 2023

– The Digital Health Advisory Committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. director of the FDA’s Center for Devices and Radiological Health.

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Healthcare IT News - Telehealth

APRIL 12, 2022

"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. WHY IT MATTERS. THE LARGER TREND. ON THE RECORD.

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Fierce Healthcare

JANUARY 26, 2024

Cognoa, maker of the first FDA-approved autism diagnostic tool, announced Highmark has signed on as its first commercial payer partner. | The tool, Canvas Dx, leverages AI to empower doctors to quickly and accurately diagnose developmental risk without bias, the company claims. It is the first FDA-approved autism diagnostic tool.

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Fierce Healthcare

AUGUST 6, 2024

FDA releases roster of digital health advisory committee, chaired by American College of Cardiology innovation officer ebeavins Tue, 08/06/2024 - 10:26

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Healthcare IT News - Telehealth

JANUARY 3, 2022

"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. The FDA notes that digital health tools used for remote data acquisition can offer an important role in clinical research. WHY IT MATTERS.

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HIT Consultant

SEPTEMBER 14, 2023

Food and Drug Administration (FDA) for the triage and notification of obstructive hydrocephalus (OHCP) on non-contrast brain CT scans. has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. s most comprehensive FDA-cleared AI triage solutions. Annalise.ai Annalise.ai

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Healthcare IT News - Telehealth

APRIL 4, 2024

FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time. European pedigree FDA clearance is significant for a system which is already CE-MDR medically certified in Europe.

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HIT Consultant

OCTOBER 30, 2024

– As the first FDA-cleared self-neuromodulation device for post-traumatic stress disorder (PTSD), Prism for PTSD™ offers a new approach to managing this debilitating condition.

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Healthcare Dive

FEBRUARY 2, 2022

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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HIT Consultant

OCTOBER 4, 2024

Food and Drug Administration (FDA) for a groundbreaking tool in the fight against Alzheimer’s disease. What You Should Know: – GE HealthCare a nnounced today that its MIM Software has received 510(k) clearance from the U.S.

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HIT Consultant

OCTOBER 6, 2024

What You Should Know: – BioIntelliSense , a leader in continuous health monitoring, has received FDA clearance for its rechargeable BioButton Multi-Patient wearable and BioDashboard system.

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HIT Consultant

APRIL 19, 2024

What You Should Know: – Scopio Labs , a leader in digital cell morphology, has achieved a major breakthrough with FDA De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) Application. AI-powered decision support system (DSS): Assists with tasks like cell detection and categorization, improving efficiency. “We

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HIT Consultant

OCTOBER 8, 2024

Food and Drug Administration (FDA). With its initial focus on cardiology, AccurKardia provides innovative cloud-based diagnostic tools, including AccurECG™4, an FDA-cleared Class II software as a medical device (SaMD) that offers fully automated, near real-time ECG interpretation.

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Healthcare IT News - Telehealth

APRIL 4, 2024

FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time. European pedigree FDA clearance is significant for a system which is already CE-MDR medically certified in Europe.

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HIT Consultant

DECEMBER 8, 2023

Food and Drug Administration (FDA) for its Smileyscope™ Therapy system. – The FDA clearance marks Smileyscope as the first and only VR Analgesic™ available in the US. “We were thrilled to receive this FDA Class II clearance. The Digital Therapeutics market is projected to reach 32.5 billion USD by 2030.

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HealthIT Answers

MAY 30, 2024

The post FDA Promotes Clinical Trial Innovation appeared first on Health IT Answers. By Hilary Marston MD MPH & Kevin Bugin PhD - Breakthroughs in science and technology are advancing innovation in more areas of medicine, providing novel treatment options for patients.

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HIPAA Journal

MARCH 30, 2023

Food and Drug Administration (FDA) will not authorize their use. trillion omnibus spending bill – The Consolidated Appropriations Act, 2023 – took effect and the FDA now requires all regulatory submissions for medical devices to include information about the cybersecurity measures that have been implemented for the devices.

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HIT Consultant

NOVEMBER 5, 2023

– This clearance expands the platform to include a total of six FDA-cleared digital biomarkers, out of the 128 digital measures supported, making it one of the most comprehensive solutions available for use in clinical trials.

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HIT Consultant

SEPTEMBER 9, 2024

Food and Drug Administration (FDA). What You Should Know: – Withings , a global leader in connected health, has announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Addressing the Underdiagnosis of Sleep Apnea Sleep apnea is a serious condition that affects millions of people worldwide.

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HIPAA Journal

APRIL 11, 2022

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 FDA will then work on a final version of the guidance.

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Mobi Health News

APRIL 11, 2024

FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time. Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking.

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Healthcare Dive

AUGUST 5, 2023

The approval of Zurzuvae marks the first time the FDA has approved a pill for postpartum depression.

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HIT Consultant

JANUARY 22, 2024

Food and Drug Administration (FDA) 510(k) clearance for its latest update, v3.0.0. – This FDA clearance paves the way for American hospitals to now harness the software’s advanced capabilities, marking a significant step forward in lung disease diagnosis and treatment. .

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HIT Consultant

JANUARY 26, 2024

Food and Drug Administration (FDA) has selected Deliberate AI’s AI-generated Clinical Outcome Assessment (AI-COA™) for its Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. – The collaboration between Deliberate AI and the FDA represents a giant leap in the fight against mental illness.

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Mobi Health News

SEPTEMBER 15, 2023

The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.

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Fierce Healthcare

APRIL 24, 2024

Medical devices and other innovations that make acute and on-going at-home clinical management possible are receiving a boost in attention from FDA. The Food & Drug Administration’s device center launched an initiative to promote at-home medical device development with a focus on health equity in at-home care.

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HIT Consultant

JUNE 20, 2024

. – The ColdVest is the first-of-its-kind, Class 1 FDA-approved portable emergency cooling device. Protecting Lives in the Face of Rising Temperatures The ColdVest is the first-of-its-kind, Class 1 FDA-approved portable emergency cooling device.

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Mobi Health News

APRIL 11, 2024

FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time. Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking.

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Hall Render

OCTOBER 18, 2024

Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023.

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HIT Consultant

JULY 2, 2024

What You Should Know: – Eli Lilly’s Kisunla™ (donanemab-azbt) has been approved by the FDA as a treatment for adults in the early stages of Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and mild dementia, who have confirmed amyloid plaque buildup in the brain.

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