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

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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COVID-19 Vaccine FDA COVID-19 244

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

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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FDA COVID-19 246

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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FDA 231

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

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

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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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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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

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

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

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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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

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

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

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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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

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

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

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

Healthcare Dive

AUGUST 30, 2022

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

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COVID-19 FDA Public Health 261

Healthcare Dive

NOVEMBER 16, 2023

The report proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.

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FDA 293

Healthcare Dive

FEBRUARY 3, 2022

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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FDA 261