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

RedDress Donates FDA-Cleared Wound Care Solution to Aid Injured Ukrainians

by Fred Pennic 03/24/2022 Leave a Comment

RedDress Donates FDA-Cleared Wound Care Solution to Aid Injured Ukrainians

What You Should Know: - RedDress, a Florida-based Israeli medical company is shipping revolutionary blood-clotting wound care systems to Ukraine to help with serious injuries and severe trauma wounds. - 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
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Podimetrics Secures $45M for SmartMat to Prevent Diabetic Amputations in High-Risk Patients

by Fred Pennic 03/24/2022 Leave a Comment

Independence Blue Cross Taps Podimetrics to Prevent Diabetic Amputations Via RPM

What You Should Know: - Podimetrics raises $45M to help at-risk providers and health plans prevent diabetic amputations in high-risk patients. - With this latest round of funding, Podimetrics plans to focus on hiring to build out their product development and research teams, while also expanding the breadth of services delivered by their nurse support team. Podimetrics, a care management company with the leading solution to help prevent costly and deadly diabetic foot ulcer (DFUs)
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Eko Unveils Newly Designed Heart Disease Detection App

by Fred Pennic 03/22/2022 Leave a Comment

Eko Unveils Newly Designed Heart Disease Detection App

What You Should Know: - Eko, a digital health company advancing heart and lung disease detection, today announced the launch of its newly-redesigned Eko App, which will transform patient interactions into an opportunity to screen for cardiovascular disease. Heart disease is the leading cause of death in the U.S., and there has not been an efficient and affordable solution to screen for heart disease at the physical exam until now. - Eko has transformed the traditional stethoscope into an
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physIQ, CellCarta Collaborate on Study to Revolutionize Vaccine

by Jasmine Pennic 03/17/2022 Leave a Comment

physIQ, CellCarta Collaborate on Study to Revolutionize Vaccine

What You Should Know: - Today, digital medicine leader physIQ and CellCarta, a global leader in precision medicine services announced they are collaborating on a groundbreaking study that could revolutionize vaccine development. - The strategic collaboration advances the detailed study of early, individualized human responses to vaccinations as pharma companies race to deliver safe, effective vaccines sooner. physIQ, a pioneer in digital medicine, and CellCarta, a global leader in
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Avive Raises $22M for Connected AED Platform for Out-of-Hospital Cardiac Arrest

by Fred Pennic 03/16/2022 Leave a Comment

Avive Raises $22M for Connected AED Platform for Out-of-Hospital Cardiac Arrest

What You Should Know: Avive Solutions, Inc., developer of an intelligent AED and connected response platform for out-of-hospital cardiac arrest (OHCA) emergencies, today announced that it closed a $22 million Series A round of financing co-led by Questa Capital, Catalyst Health Ventures and repeat investor Laerdal Million Lives Fund. - This funding will be used to advance a new technology-enabled approach for improving OHCA survival rates. Ryan Drant, founder and managing partner of Questa
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GE Healthcare & AliveCor Integrate Data from ECGs Into Clinical Workflow

by HIMSS22 Strategic Partnershipss 03/16/2022 Leave a Comment

AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms

What You Should Know: - AliveCor and GE Healthcare announced they are partnering to integrate data from AliveCor’s KardiaMobile 6L electrocardiogram (ECG) device directly into GE Healthcare’s MUSE Cardiac Management System (MUSE). - Today, cardiologists often rely on real-time data from personal electrocardiogram (ECG) devices to help manage patients with cardiac conditions like atrial fibrillation (AFib). AliveCor’s KardiaMobile 6L ECG offers the only
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HIMSS22 Day 2 Roundup: Google Partners with MEDITECH, Microsoft’s Health Cloud Strategy Expansions

by Fred Pennic 03/15/2022 Leave a Comment

HIMSS22 Day 2 Roundup: Google Partners with MEDITECH, Microsoft’s Health Cloud Strategy Expansions,

Mergers & Acquisitions (M&A) Activity OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform OptimizeRx, a provider of point-of-care technology solutions helping patients start and stay on therapy announced a definitive agreement to acquire the EvinceMed platform and related assets. EvinceMed is a provider in delivering end-to-end automation for specialty pharmaceutical transactions. The acquisition includes the full Market Access Management Platform
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Philips Capsule Surveillance Receives 510(k) Clearance

by FDA Clearances 03/15/2022 Leave a Comment

Philips Capsule Surveillance receives 510(k) clearance

What You Should Know: - Philips Capsule Surveillance solution has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA), paving the way for widespread deployment across healthcare systems in the USA. - Capable of utilizing streaming data from virtually any connected medical device, the solution aggregates patient data, analyses it to generate actionable insights and alerts, and sends timely notifications to the patient’s caregivers so that they can
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Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis

by Jasmine Pennic 03/10/2022 Leave a Comment

Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis

What You Should Know: - Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding in the company to over $20 million, including partnerships with Foxconn, Roche Diagnostics, the Defense Threat Reduction Agency, and others.   - Precision medicine company will use the funding to
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MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform

by Fred Pennic 03/09/2022 Leave a Comment

MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform

What You Should Know: - MediView XR, Inc., raises $9.9M in SAFE financing syndicated by Inside View Investments, LLC, a private investment firm.  MediView has raised approximately $14.4MM in total funding to date. - Investment will support key technology development, commercialization and regulatory submissions. MediView XR Inc., a Cleveland-based medtech company that leverages augmented reality, remote connectivity and spatial computing data to create revolutionary surgical
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