Healthcare IT Today

FEBRUARY 11, 2021

The FDA has agreed to a special authorization allowing a vendor to deploy its AI tool designed to predict adverse events in hospital ICUs.

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HIPAA Journal

MARCH 30, 2023

According to the FBI, more than half of all medical devices used by hospitals have critical vulnerabilities that have not been addressed and, on average, medical devices have more than 6 vulnerabilities that could potentially be exploited by malicious actors. Food and Drug Administration (FDA) will not authorize their use.

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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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Healthcare It News

DECEMBER 16, 2022

A "perfect storm" of financial stress for hospitals and health systems. FDA and evolving regulations for digital therapeutics, software as a medical device. Subscribe to the podcast on Apple Podcasts , Spotify or Google Play ! Talking points: The future of the Public Health Emergency and the flexibilities it allows.

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Electronic Health Reporter

JULY 19, 2019

Food and Drug Administration (FDA), shortages continue to increase. The article Transforming How Hospitals Identify and Manage Drug Shortages appeared first on electronichealthreporter.com. Prescription drug shortages are an epidemic across the U.S health care system. According to the U.S.

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Healthcare IT Today

JANUARY 21, 2025

Just last year, the FDA released new guidance on cybersecurity for medical devices, including requirements for securing medical devices postmarket. The FDAs primary guidance is that manufacturers have a plan for the rapid testing, evaluation, and patching of devices deployed in the field. Whats Next?

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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. The company envisions widespread adoption in hospitals, doctor’s offices, and an expanded range of patients benefiting from their drug-free treatments.

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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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HIT Consultant

OCTOBER 8, 2024

Food and Drug Administration (FDA). With its initial focus on cardiology, AccurKardia provides innovative cloud-based diagnostic tools, including AccurECG™4, an FDA-cleared Class II software as a medical device (SaMD) that offers fully automated, near real-time ECG interpretation.

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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. This is great news for patients who stand to benefit from the latest and greatest technology, but it can be tough for hospitals and doctors to keep up with all of the new devices on the market. PMA Applicant: Allergan.

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HIT Consultant

NOVEMBER 4, 2024

This initial procedure highlights the potential of the device to streamline the patient experience and reduce hospital visits by combining two critical PAD therapies in one device. Food and Drug Administration (FDA), the trial aims to assess the system’s safety and effectiveness in achieving procedural success with minimal complications.

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HIT Consultant

NOVEMBER 17, 2024

When a patient is admitted to the hospital, identifying illness or infection quickly has a profound impact on allowing for prompt treatment with antibiotics and can also be critical in the early identification of serious, life-threatening conditions like sepsis.

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Healthcare IT Today

JANUARY 23, 2025

One way for a company to earn trust for its AI solutions is through the rigorous FDA approval process. Dr. Samir Shah, Chief Medical Officer at Qure.ai , recently agreed to sit down with Healthcare IT Today to discuss the companys focus on seeking FDA approval for its AI solutions. is proof that it works. Learn more about Qure.ai

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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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Healthcare IT Today

FEBRUARY 2, 2025

Studies Hospitals ended 2024 with operating margins of 6%, and health systems with margins of 2.1% , according to the latest data from Strata Decision. GE HealthCare received FDA clearance for the latest version of Voluson Expert Series ultrasound systems. Inpatient and outpatient volumes are rising, while ED visit volume is falling.

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HIT Consultant

MARCH 24, 2022

– RedDress began shipments of 400 of their ActiGraft systems this week to multiple hospitals in Ukraine to help treat civilian casualties as a result of the indiscriminate Russian attacks. ActiGraft: Recreating the Natural Wound Healing Environment.

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HIT Consultant

JULY 21, 2022

What You Should Know: – RapidAI , the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity , the newest addition to the RapidAI platform. The key benefits of Rapid Hyperdensity include: 1.

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HIPAA Journal

NOVEMBER 16, 2022

healthcare organizations, the Food and Drug Administration (FDA) asked MITRE to develop a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook to help hospitals and healthcare delivery organizations (HDOs) develop a cybersecurity preparedness and response framework.

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HIT Consultant

APRIL 30, 2025

Traditional MRI systems are large, extremely expensive, and require complex hospital infrastructure, restricting their deployment primarily to major hospitals. Expansion Plans The company plans to produce its first clinical prototypes by the end of 2025 and commence investigational trials in hospital settings starting in 2026.

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HIT Consultant

AUGUST 23, 2024

What You Should Know: – Qure.ai, a global innovator in medical imaging AI, has today announced a pivotal 510(k) FDA clearance for its AI-powered chest CT solution – qCT LN Quant. Headquartered in Mumbai, Qure.ai operates regional offices in New York and London.

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Healthcare IT Today

JANUARY 15, 2025

The trend is already clear, with FDA approvals for AI-related products rising significantly, from 650 devices in 2023 to 950 in 2024. For example, using AI-powered remote wearables for monitoring their hearts will allow patients to benefit from a hospital-quality tool without having to travel to a facility.

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Healthcare It News

NOVEMBER 16, 2023

Pentavere partners with hospital networks on data abstraction and structuring. " FDA clears Lunit breast cancer screening algorithm Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, announced Tuesday that the U.S. breast screening market.

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HIT Consultant

OCTOBER 15, 2024

What You Should Know: – Vivalink , a provider of digital healthcare solutions, is making it easier for nonprofit hospitals to adopt Hospital-at-Home (HaH) programs with the launch of its new HaH Starter Program. – Vivalink is offering this program at no cost to eligible hospitals in the U.S.

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Healthcare IT Today

DECEMBER 22, 2024

It’s initially being used in Stelo, Dexcom’s FDA-cleared over-the-counter glucose biosensor. Sales Tennessee safety net hospital Nashville General Hospital implemented Oracle Health CommunityWorks. Company News Cellular blood pressure monitor BPM Pro 2 from Withings Health Solutions received FDA clearance.

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HIT Consultant

APRIL 24, 2024

What You Should Know: – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its Philips Zenition 30 mobile C-arm has received FDA 510(k) clearance, making image-guided surgical procedures available to more US patients at lower cost.

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Healthcare It News

APRIL 27, 2023

" According to an email from a Philips representative, the announcement marks the first commercialized use of the technology following two years of field testing, publication of a peer-reviewed clinical study and the FDA’s classification of RATE as a wellness device.

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Bill of Health

JUNE 20, 2023

The selections feature topics ranging from an investigation of federal support for the development of expensive HIV drugs, to an analysis of COPD exacerbations and hospitalizations among new users of maintenance inhalers, to a comparison of sales for new drugs with and without an initial orphan drug designation. Clin Pharmacol Ther.

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Healthcare It News

MAY 12, 2023

It's available free to users on Belong's Beating Cancer Together app and also available as a customizable SaaS solution for hospitals, providers and patient support programs. Dave also retains a long-term memory of previous correspondence, allowing continuous communication across multiple chat sessions, according to the company.

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HIT Consultant

FEBRUARY 17, 2025

What You Should Know : – BioIntelliSense , a leader in continuous health monitoring and clinical intelligence, and Hicuity Health , a leading provider of tech-enabled virtual care services, today announced a strategic partnership to offer fully managed, end-to-end continuous patient monitoring to hospitals and health systems.

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HIT Consultant

NOVEMBER 14, 2023

Jiajing Chen, Data Scientest What You Should Know: – Mercy has developed a new AI-driven texting platform called The Chen Chemotherapy Model, which is helping to keep chemotherapy patients out of the hospital by raising red flags before symptoms become severe. In a pilot study, the model was able to reduce hospitalizations by 20%.

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Mobi Health News

APRIL 24, 2019

Recently deployed in US and UK hospitals, the company's upper-arm wearable and accompanying platform may now go home with the patient.

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Healthcare IT Today

MARCH 28, 2025

solutions are driving a significant improvement through early lung cancer detection within hospital systems. Its radiology solution is available to 1 in 2 radiologists in Australia, and processes scans for more than 45 Trusts and over 131 public hospitals in the United Kingdom, including 35% of chest X-ray volume in England.

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HIPAA Journal

MARCH 27, 2025

IoMT devices include imaging systems, patient devices, surgical devices, hospital information systems, and clinical IoT. If these devices and systems are compromised they can cause major disruption to hospital operations and patient care. The industrial cybersecurity platform provider Claroty analyzed more than 2.25

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Healthcare IT Today

DECEMBER 6, 2022

Growth-stage funding will power the company’s expansion as demand soars for MIC’s FDA-cleared platform, Sickbay™, which unlocks waveform data from the patient’s bedside to help hospitals rapidly scale bed and staff capacity, stratify risk and deliver patient-centered, data-driven care. . Medical Informatics Corp.

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Jane Sarashon

FEBRUARY 13, 2025

doctors would want to see increased oversight in terms of regulatory actions that could increase their trust in adopting AI tools — such as oversight from the FDA, the top-ranked regulatory action noted in the survey among nearly one-half for “first” and by another 18% for “second” regulatory desire. First, U.S.

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Healthcare IT News - Telehealth

MAY 6, 2020

They also keep patients with less severe cases out of hospitals, so preserving precious bed space for patients with severe cases. Hospitals across the nation are using connected health and RPM to great effect during the pandemic.

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HIPAA Journal

DECEMBER 22, 2022

The 4,155-page bill includes many healthcare provisions that will help hospitals and health systems provide better care for patients. This will help to ensure that telehealth and hospital-at-home programs can continue to provide convenient and accessible medical treatment for patients.

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