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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FDA 98

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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FDA 232

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 94

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

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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FDA 130

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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FDA 159

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-19 209

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-19 225

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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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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FDA HIPAA Hospitals Compliance 109

HIT Consultant

JULY 28, 2023

What You Should Know: UltraSight , a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology.

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FDA Hospitals 97

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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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-19 218

HIT Consultant

SEPTEMBER 6, 2023

What You Should Know: Flatiron Health today announced its renewed collaboration with the Oncology Center of Excellence (OCE) of FDA to jointly develop and implement specific research projects to advance the use of Real World Data (RWD) and explore the potential strengths and limitations of using Real World Evidence (RWE) for regulatory purposes.

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FDA 52

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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FDA HIPAA 128

HIT Consultant

MAY 8, 2023

What You Should Know: Today, Samsung announced today its Irregular Heart Rhythm Notification feature of the Samsung Health Monitor App has been cleared by the FDA. With this new feature, Galaxy Watch users can be alerted when heart rhythms suggestive of atrial fibrillation (AFib) – a type of arrhythmia – are detected.

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FDA 98

Digital Health News

MAY 9, 2023

Ultromics has gained FDA Breakthrough Device Designation for its AI-powered EchoGo Amyloidosis platform, which is speeding up diagnosis.

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FDA 72

Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.

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Informed Consent FDA 52

HIT Consultant

AUGUST 23, 2023

What You Should Know: Welldoc® , a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®.

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FDA 98

HIT Consultant

AUGUST 29, 2022

In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Here’s a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some of these new FDA medical devices will truly impress you. PMA Applicant: Allergan.

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FDA Medical Device Industry Doctors Hospitals 98

HealthIT Answers

JULY 25, 2023

What's trending now is the new safety warnings on an opioid Rx from the FDA. The post FDA Safety Warning on Opioid Medications appeared first on Health IT Answers. Now on-demand, Trending NOW episode with host Jared Johnson and his guest Galit Zuckerman-Stark, CEO and Founder of Medasense Biometrics.

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FDA 52

HIT Consultant

MARCH 15, 2023

– TytoCare , a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US.

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FDA Health Outcomes 98

Health Law Advisor

MARCH 14, 2023

Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.” In a March 6, 2023 constituent update , the U.S.

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FDA 52

Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

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FDA Licensing Compliance 40

Healthcare Dive

FEBRUARY 15, 2022

Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.

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FDA 130

HIT Consultant

APRIL 3, 2023

What You Should Know: – Today, Butterfly Network announced it received 510(k) clearance from the FDA for a groundbreaking AI-enabled tool named AI-enabled Auto B-line Counter that will help physicians assess adults’ lungs and accelerate providers’ abilities to make informed treatment decisions.

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Mobi Health News

MAY 3, 2023

The startup plans to file with the FDA to add other monitoring abilities and to introduce the product later this year.

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FDA 105

Digital Health News

JUNE 1, 2023

A miniature robotic system from THINK Surgical has gained FDA clearance, and will open up robotic-assisted surgery to more knee replacement patients.

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FDA 76

HIT Consultant

DECEMBER 8, 2022

What You Should Know: – The FDA has cleared Dexcom G7 continuous glucose monitoring (CGM) system in the U.S. for people with all types of diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution.

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FDA 97

Health Law Advisor

JANUARY 3, 2023

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. Product codes are the language of FDA regulation. Every medical device FDA regulates is placed into a product code.

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FDA Medical Device Industry 98

Healthcare IT News - Telehealth

DECEMBER 20, 2021

"The in-person dispensing requirements on medication abortion care have proven to be unnecessary during the pandemic, and the FDA did the right thing today by lifting them," said Kirsten Moore, director of the Expanding Medication Abortion Access Project, in a statement. ON THE RECORD.

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Telemedicine FDA COVID-19 Public Health 121

Bill of Health

JUNE 1, 2023

Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban. By Doron Dorfman On May 11, the U.S. Despite this nuance, the new policy categorically excludes PrEP users.

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FDA Public Health Licensing 227

Fierce Healthcare

JANUARY 27, 2023

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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FDA 128

Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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FDA Informed Consent COVID-19 Fraud 40

HIT Consultant

AUGUST 3, 2023

Food and Drug Administration (FDA). The submission has passed the first milestone of the review process, an initial review for completeness, and is now under full review by the FDA. Evie Ring’s Clinical Performance One of the most critical components of the FDA submission is the ring’s clinical performance.

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FDA 52

HIPAA Journal

OCTOBER 1, 2022

The FDA’s authorization to collect fees from the healthcare sector to conduct independent reviews of drugs and medical devices was due to come to an end on September 30, and with time running out, the FDA bowed to pressure from Senate republicans and stripped out the new cybersecurity requirements for medical device manufacturers.

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FDA HIPAA Governance 81

HIT Consultant

APRIL 8, 2022

What You Should Know: – Arterys , the world’s leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.

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FDA 98