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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

Former FDA Commissioner Returns to Venture Capital Firm As Special Partner

by Fred Pennic 05/22/2019 Leave a Comment

FDA Commissioner Scott Gottlieb to Step Down

Former FDA Commissioner Scott Gottlieb, M.D. is returning to global venture capital firm New Enterprise Associates (NEA) as a Special Partner on the firm’s healthcare investment team. Dr. Gottlieb was a Venture Partner at NEA from 2007 to 2017 before being appointed the 23rd Commissioner of the U.S. Food and Drug Administration (FDA), where he served from 2017 to 2019.Dr. Gottlieb is a physician, policy expert, and advocate for healthcare entrepreneurship, innovation, and access. He is focused
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Biofourmis Lands $35M for AI-Powered Digital Therapeutics Platform

by Jasmine Pennic 05/21/2019 Leave a Comment

Biofourmis Lands $35M for AI-Powered Digital Therapeutics Platform

Biofourmis, a Boston, MA-based digital therapeutics platform, today announced that it has raised $35 million in Series B funding led by Sequoia Capital/Sequoia India and co-led by Mass Mutual. The latest funding round will enable the company to advance its proprietary artificialintelligence (AI)-powered digital therapeutics platform and pipeline that treats and manages a range of complex chronic conditions.Digital Therapeutics is Redefining The Healthcare Value ChainFounded in 2015, Biofourmis
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MaxQ AI Launches FDA Cleared, CE Approved Slice-Level Intracranial Hemorrhage Detection

by Fred Pennic 05/21/2019 Leave a Comment

MaxQ AI Launches FDA Cleared, CE Approved Slice-Level Intracranial Hemorrhage Detection

 MaxQ AI, an Israeli-based medical diagnostic AI company has launched the company’s new ACCIPIO Ax solution, which features SliceMap, an integrated view that guides clinicians rapidly to CT slices with suspected intracranial hemorrhage (ICH) without leaving their PACS viewer. Slice-Level Intracranial Hemorrhage DetectionACCIPIO Ax is FDA Cleared, CE Approved, and the second component of MaxQ AI’s ACCIPIO ICH Platform, the complete ICH solution for stroke and head trauma assessment. Radiology
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3 Challenges of Healthcare Internet of Things (IoT) Performance Testing

by Maxim Chernyak, Head of Test Automation & Performance Testing Lab at A1QA 05/21/2019 Leave a Comment

Is Internet of Medical Things (IoMT) on Par With the IoT Market as a Whole?

There’s no doubt that the internet of things (IoT) creates a new technological ecosystem in healthcare, helping organizations manage bottlenecks in care and bridging the gap between patients and providers. The list of applications for connected devices in hospitals keeps growing from real-time staff tracking across facilities to ensuring preventive equipment maintenance and 24/7 patient vitals monitoring in ER and resuscitation departments.But care delivery doesn’t stop after discharge. A range
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Verily Launches Baseline Health System Consortium with Duke, Mayo, Vanderbilt

by Jasmine Pennic 05/16/2019 Leave a Comment

Duke, Mayo, Vanderbilt, Others Join Verily’s Baseline Health System Consortium

Verily, an Alphabet company, today announced a new Project Baseline initiative, the Baseline Health System Consortium, comprised of Verily, Duke University Health System, Vanderbilt University Medical Center, University of Mississippi Medical Center, Mayo Clinic, Regional Health in South Dakota and the University of Pittsburgh. Verily launched Project Baseline in 2017 with the Project Baseline Health Study to develop the technology and tools to help researchers create a more comprehensive map of
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StartUp Health Adds 11 New Startups to Army of Healthcare Transformers

by Jasmine Pennic 05/15/2019 Leave a Comment

StartUp Health Adds 11 New Startups to Army of Healthcare Transformers

StartUp Health, a platform where health transformers, partners, customers, investors, patients, and caregivers connect and accelerate the progress of the health moonshots.Here is a look at the 11 new members of Startup Health’s global army of healthcare transformers:1. Cityblock Health: Iyah Romm (Co-Founder & CEO)Cityblock is a Brooklyn, NY-based company building sustainable, scalable systems that provide high-quality, cost-effective care for underserved populations with complex health
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Zebra Medical Vision Granted FDA 510k Clearance for AI Chest X-Ray Triage

by Fred Pennic 05/13/2019 Leave a Comment

Zebra Medical Vision Granted FDA 510k Clearance for AI Chest X-Ray Triage

Zebra Medical Vision, an Israli-based deep learning imaging analytics company, today announces that it has received FDA 510(k) clearance for HealthPNX – an AI-powered alert for pneumothorax (PNX), based on chest X-rays.FDA 510(k) Clearance DetailsReceived in May 2019, the FDA 510(k) clearance focuses on an AI alert for “stat” (urgent) findings of pneumothorax and demonstrates a promising potential to substantially reduce turnaround time and increase the radiologist’s confidence in making this
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Philips, Medtronic Partner to Advance The Image-Guided Treatment of Atrial Fibrillation

by Jasmine Pennic 05/10/2019 Leave a Comment

Philips, Medtronic Partner to Advance The Image-Guided Treatment of Atrial Fibrillation

Royal Philips has announced a collaboration with Medtronic to further advance treatment of paroxysmal atrial fibrillation (PAF), a common heart rhythm disorder. Through the agreement, Medtronic will facilitate sales of products on behalf of Philips to provide an innovative, integrated image guidance solution for cryoablation procedures.Impact of Atrial FibrillationAtrial fibrillation (AF) affects more than 33 million people worldwide. Cryoballoon ablation is used in a minimally invasive
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Neural Analytics Lands $22M for Robotically Assisted Ultrasound System for Brain Health Assessment

by Fred Pennic 05/10/2019 Leave a Comment

Neural Analytics, Inc., a Los Angeles, CA-based medical robotics company developing and commercializing technologies to measure and track brain health has raised $22 million in Series C funding led by Alpha Edison and the Company has also issued warrants to purchase stock in connection to the financing. The investment brings Neural Analytics’ total funding to approximately $66 million.Impact of Neurological DiseasesNeurological diseases such as stroke affects more than 795,000 people each year
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Podimetrics Raises $13.4M for FDA-Cleared Solution to Prevent Diabetic Foot Ulcers

by Fred Pennic 05/09/2019 Leave a Comment

Podimetrics Raises $13.4M for FDA-Cleared Solution to Prevent Diabetic Foot Ulcers (DFUs)

Podimetrics, a care management company with the leading solution to help prevent costly and deadly diabetic foot ulcer (DFUs) has raised $13.4M in Series B funding round from investors Rock Health, Norwich Ventures, and Scientific Health Development.Impact of Diabetic Foot Ulcers for PatientsDiabetic foot ulcers are a major complication of diabetes and are one of the most devastating and costliest diabetes complications -they can lead to debilitating amputations that cost on average $100k. In
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