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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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

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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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

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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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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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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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

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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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 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

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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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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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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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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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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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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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

MARCH 6, 2024

NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription. What You Should Know: DexCom, Inc. There are approximately 25 million people in the U.S.

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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

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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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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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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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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HIT Consultant

NOVEMBER 9, 2023

What You Should Know: – RapidAI has received FDA clearance for Rapid SDH, its AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma. – The need for the RapidAI solution is urgent, with SDH cases in US patients expected to increase by nearly 80% before 2040.

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Fierce Healthcare

DECEMBER 13, 2023

At stake are access to the nation's most frequently used abortion drug and the regulatory authority of the FDA. Jackson ruling.

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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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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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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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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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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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Dot Compliance

FEBRUARY 15, 2024

On January 31st, 2024, almost a year after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule. director of the FDA’s Center for Devices and Radiological Health. What Is QMSR?

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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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