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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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

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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COVID-19 Vaccine FDA COVID-19 246

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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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 162

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The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions.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 336

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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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 297

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 276

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 261

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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Healthcare It News

NOVEMBER 7, 2023

Previously, on September 25, FDA cleared the VR system for the drug-free, temporary relief of acute anxiety associated with needle procedures, Smileyscope said. The company holds a patent for Procedural Choreography, a proprietary technique that reframes real-world stimuli with positive virtual stimuli.

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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 278

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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HIT Consultant

DECEMBER 2, 2024

What You Should Know: – Nonin Medical , a global leader in noninvasive medical monitoring lauches TruO2 OTC, the first over-the-counter (OTC) fingertip pulse oximeter to receive FDA clearance. – Nonin Medical’s founder, Phil Isaacson, was the original inventor of the fingertip pulse oximeter.

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FDA 105

Healthcare Dive

MARCH 22, 2024

Two weeks after the FDA updated Wegovy’s label, Medicare changed its stance to allow people with a history of heart disease to receive treatment, a shift that could further boost access to the fast-selling medicine.

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Medicare Medicare FDA 331

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 330

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 317

Healthcare Dive

APRIL 29, 2024

Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.

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FDA 246

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 278

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 298

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 264

Healthcare Dive

APRIL 29, 2022

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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FDA 298

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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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 264

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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Healthcare Dive

JUNE 30, 2023

Regulators are asking for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

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FDA 261

Healthcare Dive

FEBRUARY 1, 2022

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 246

Bill of Health

APRIL 24, 2023

Dmitry’s talk, “Evergreening: The FDA’s Role in the Creation of Balanced Rights for Pharmaceutical Improvements,” was developed into an article and published in the Iowa Law Review in 2019 titled “The More Things Change: Improvement Patents, Drug Modifications, and the FDA.”

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Healthcare Dive

MARCH 30, 2022

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 244

Healthcare Dive

MAY 19, 2022

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

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FDA 264

Healthcare Dive

OCTOBER 13, 2022

Pfizer's reformulated vaccine is now authorized for use in children at least 5 years of age, while Moderna's will be available for kids as young as 6.

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FDA 260

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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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 Nurses Hospitals 138

Bill of Health

MARCH 12, 2024

Yet, once approved, FDA will put limits on the approved drug. The MDMA NDA Back in December 2023, Lykos Therapeutics (formerly MAPS PBC ) submitted a New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), which FDA recently granted priority review.

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Healthcare Dive

APRIL 8, 2022

The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

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