Bill of Health

NOVEMBER 9, 2022

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. By Matthew Chun.

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Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

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FDA Pharmaceutical Industry COVID-19 Public Health 184

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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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 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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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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FDA 85

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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FDA Hospitals Nurses 116

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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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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FDA 101

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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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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FDA 91

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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FDA 84

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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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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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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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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HIT Consultant

DECEMBER 6, 2023

What You Should Know: Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI).

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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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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

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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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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Healthcare Dive

JANUARY 5, 2024

The clearance is a major shift for the agency, which described its decision as a “first step” in allowing Florida to bulk purchase lower-cost Canadian medicines.

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FDA 307

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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HIT Consultant

FEBRUARY 20, 2024

Food and Drug Administration (FDA) granting 510(k) clearance for its Smart Skin solution, marketed as the X-trodes System M. – The FDA clearance positions X-trodes as a frontrunner in democratizing advanced electrophysiological monitoring. It will further shorten the path to commercialization for a range of clinical use cases.”

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Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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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

APRIL 23, 2024

What You Should Know: Exo® (pronounced “echo”) , a medical imaging software and devices company, today announced its FDA-cleared cardiac and lung artificial intelligence (AI) applications are now available on Exo Iris™, Exo’s high-performance handheld ultrasound device.

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HIT Consultant

APRIL 24, 2024

What You Should Know: – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its Philips Zenition 30 mobile C-arm has received FDA 510(k) clearance, making image-guided surgical procedures available to more US patients at lower cost.

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FDA Hospitals 89

HIT Consultant

FEBRUARY 12, 2024

What You Should Know: – Samsung’s Galaxy Watch has received De Novo authorization from the US Food and Drug Administration (FDA) for its sleep apnea detection feature. – This marks a significant step forward in wearable technology, making it the first of its kind to be approved by the FDA for detecting potential sleep apnea.

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FDA 94

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

OCTOBER 11, 2023

Food and Drug Administration (FDA) to advance the use of real-world data (RWD) in the U.S. Study Goals & Objectives The goal of the study is to better understand how patients with rare cancers present and are treated to inform drug development for life sciences companies and the FDA. community oncology setting.

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FDA 93

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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FDA 107

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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Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context. Practical Implications.

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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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Healthcare Dive

NOVEMBER 16, 2023

The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.

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HIT Consultant

JANUARY 31, 2024

Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for 23ME-01473 (referred to as ‘1473), paving the way for the first human clinical trial of this promising new therapy. – With FDA clearance secured, 23andMe plans to initiate a Phase 1 clinical trial in the first half of 2024.

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FDA 96