Bill of Health

MARCH 19, 2024

Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. However, in 2016, DEA added some clarity to the “accepted medical use” qualification, saying that FDA approval was one way to achieve this threshold.

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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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FDA 97

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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FDA 98

Healthcare Dive

MAY 27, 2025

The agency recommends manufacturers update their vaccines to target the JN.1 At the same time, HHS head Robert F. Kennedy Jr. is removing guidance that healthy children and pregnant women receive COVID shots.

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FDA 157

HIT Consultant

APRIL 15, 2025

TytoCare lung exam What You Should Know: – TytoCare , a pioneering virtual care company dedicated to delivering accessible, high-quality primary care from the comfort of home announced the company has become the first in the world to receive FDA clearance for its AI-based detection of all three major abnormal lung sounds.

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FDA 71

Compliancy Group

DECEMBER 23, 2024

Food and Drug Administration (FDA) holding them accountable. Researchers, vendors, and organizations who dont uphold these standards or use data that lacks integrity could face debarment from future clinical trials by the FDA. What Lands Someone on the FDA Debarment List for Clinical Trials?

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FDA Compliance Compliance Officers HIPAA 52

Healthcare Dive

FEBRUARY 20, 2025

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf, of the layoffs.

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FDA 199

Healthcare Dive

FEBRUARY 20, 2025

The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

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FDA 189

Dot Compliance

MAY 28, 2025

An electronic Quality Management System (eQMS) must support compliance with FDA regulations. Understanding the key requirements helps ensure your eQMS is audit-ready and aligned with FDA expectations for quality and compliance. System Validation The FDA expects validation of any system used in GxP processes.

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FDA Compliance 52

Healthcare Dive

APRIL 8, 2022

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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FDA 335

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 Dive

JULY 15, 2024

Lawmakers said the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure.”

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FDA 292

Bill of Health

FEBRUARY 5, 2025

Food and Drug Administration (FDA) banned the use of Red Dye No. Food and Drug Administration (FDA) banned the use of Red Dye No. The Regulatory Framework for Food and Color Additives FDA regulates the U.S. While a seemingly innocuous phrase, this language has come to haunt FDA. 15, 2025, the U.S. 15, 2025, the U.S.

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FDA Public Health 130

Healthcare Dive

FEBRUARY 11, 2025

Scott Gottlieb supports a reversion to an earlier interpretation of the 21st Century Cures Act, which would exempt more types of clinical decision support software from the FDA’s premarket review process.

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FDA 167

Healthcare Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

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FDA 322

Dot Compliance

JUNE 5, 2025

As organizations continue shifting from paper-based to digital systems, FDA 21 CFR Part 11 remains one of the most important regulations governing how electronic records and signatures are used, stored, and managed. The FDA continues to enforce Part 11 compliance during inspections.

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FDA Compliance Regulatory Compliance Governance 52

Dot Compliance

MAY 14, 2025

Short Answer: Yes, the FDA does test medical devices. Understanding the FDA’s Role in Medical Device Regulation The Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of food, drugs, medical devices, cosmetics, and electronic products.

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FDA Public Health Compliance Governance 52

Healthcare Dive

DECEMBER 4, 2024

By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.

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FDA 157

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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FDA 292

Bill of Health

MARCH 14, 2025

An FDA announcement that semaglutide injection products, the GLP-1 medication in the blockbuster drugs Wegovy and Ozempic, are no longer in shortage. An FDA announcement that semaglutide injection products, the GLP-1 medication in the blockbuster drugs Wegovy and Ozempic, are no longer in shortage.

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FDA Governance Medicaid Medicaid 130

Bill of Health

NOVEMBER 4, 2024

Food and Drug Administration (FDA) regulates tampons and menstrual cups as Class II medical devices. However, the FDA does not require tampon makers to test their products for PFAS or heavy metal contaminants. However, the FDA does not require tampon makers to test their products for PFAS or heavy metal contaminants.

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FDA 100

Healthcare Dive

JANUARY 6, 2025

The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin pigmentation.

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FDA 144

Healthcare Dive

APRIL 10, 2025

Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical institutional knowledge at the FDA.

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FDA 157

Healthcare Dive

OCTOBER 14, 2024

Several groups have been granted additional time to comply with the more than 10-year-old legislation, which requires complete end-to-end supply chain visibility for pharmaceutical products.

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FDA 258

HIT Consultant

MAY 9, 2025

Food and Drug Administration (FDA) has approved the Teal Wand , marking it as the first and only at-home self-collection device for cervical cancer screening in the United States. The Teal Wand simply offers a different, FDA-approved method for collecting the sample.

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FDA Doctors 66

Healthcare Dive

MARCH 10, 2022

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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FDA 293

HealthIT Answers

NOVEMBER 26, 2024

By Patrizia Cavazzoni MD & Peter Marks MD PhD - Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.

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FDA 59

Fierce Healthcare

NOVEMBER 19, 2024

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. |

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FDA 139

Bill of Health

DECEMBER 6, 2024

US Legal Requirements for Quantum-Powered Medical Devices In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework. Foster Institutional Plasticity: Evolve institutions like the FDA and EMA to accommodate quantum technologies.

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FDA Governance Compliance Bioethics 182

HIT Consultant

MAY 8, 2025

– As the first and only FDA-cleared device of its kind for low bone density, Osteoboost introduces a novel, protective, and preventative approach to bone health, offering a new option for tens of millions of individuals currently without effective interventions. – The launch comes as societal views on aging are evolving.

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FDA Medicare Medicare Compliance 59

Healthcare Dive

APRIL 4, 2022

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 274

Mobi Health News

MAY 28, 2025

The next-generation Swoop system software enhances image quality for ultra-low-field magnetic resonance imaging.

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FDA 89

Healthcare Dive

SEPTEMBER 22, 2022

The HHS Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.

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COVID-19 FDA 328

HIT Consultant

APRIL 15, 2025

– The FDA granted a De Novo Classification Request for CT-132, signifying the novel nature of this digital intervention. This strategy aligns with the increasing interest and FDA draft guidance on Prescription Drug Use-Related Software (PDURS). Safety Information There are no contraindications to using CT-132.

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FDA 52

Healthcare Dive

OCTOBER 19, 2023

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.

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FDA 313

HIT Consultant

DECEMBER 3, 2024

Even when manufacturers can develop patches, they may face delays due to FDA regulations that require rigorous testing and approval before updates can be distributed. The Need for FDA Patch Approval Reform The regulatory framework around medical devices creates another major challenge in addressing these vulnerabilities.

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FDA Ransomware Payment Systems Governance 105

Healthcare Dive

JUNE 16, 2022

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 273