• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

FDA Clearance

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
Read More

RefleXion Medical Receives $60M Loan for Biology Guiding Radiotherapy Machine

by Jasmine Pennic 05/02/2019 Leave a Comment

RefleXion Medical, Inc., a biotargeting oncology company developing the first and only biology-guided radiotherapy (BgRT) machine* for targeted cancer treatment has received a $60M senior secured term loan from Oxford Finance LLC. The company plans to use the loan to support the completion of the FDA clearance process for its biology-guided BgRT system and its subsequent commercial launch. Building from Positron Emission Tomography Positron emission tomography (PET) is an established
Read More

Medical Informatics Corp. Raises $11.9M for FDA-Cleared Patient Monitoring and Predictive Analytics Platform

by Fred Pennic 04/03/2019 Leave a Comment

Medical Informatics Corp. Raises $11.9M for FDA-Cleared Patient Monitoring and Predictive Analytics Platform

Medical Informatics Corp. (MIC), a Houston, TX-based provider of an FDA-cleared patient monitoring and predictive analytics platform has raised $11.9M in Series A funding led by Data Collective Venture Capital (DCVC) with significant participation from Intel Capital and the Texas Medical Center (TMC) Venture Fund.The Inaccurate State of Today’s Predictive Analytics in Hospital SystemsHospital systems across the country are searching for ways to use machine learning and AI to get ahead of
Read More

UM Spinout Fifth Eye Lands $11.5M for Early Warning Patient Deterioration System for Hospitals

by Fred Pennic 04/01/2019 Leave a Comment

UM Spinout Fifth Eye Lands $11.5M for Early Warning Patient Deterioration

Fifth Eye, a medical device software spinoff from the University of Michigan building clinical early warning patient deterioration system for hospitals has raised $11.5 million in Series A funding led by Arboretum Ventures and Cultivation Capital. Other participants in the round include were MINTS, the direct investing arm of the University of Michigan’s endowment, along with additional capital from previous investors Invest Michigan and 35 private angel investors.Why Clinicians Need A Better
Read More

FDA Authorizes Interoperable Tandem Insulin Pump for Personalized Diabetes Management

by Fred Pennic 02/14/2019 Leave a Comment

FDA Authorizes Interoperable Tandem Insulin Pump for Personalized Diabetes Management

The U.S. Food and Drug Administration (FDA) has permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, Referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable insulin pump, meaning it can be used with different components that make up diabetes therapy systems,
Read More

IDx and Topcon Join Forces to Scale AI-based Diagnostic Platform in the U.S. Market

by Fred Pennic 10/22/2018 Leave a Comment

IDx and Topcon Join Forces to Scale AI-based Diagnostic Platform in the U.S. Market

IDx, an AI diagnostics company, and Topcon, one of the world’s leading ophthalmic device manufacturers, have signed an exclusivity agreement that will allow the companies to scale delivery of AI-based diagnostic solutions in the U.S. market. As part of the agreement, is granted exclusive rights to IDx-DR system, an autonomous AI system that instantly detects diabetic retinopathy in fundus images, exclusively with Topcon NW400, an easy to use, robotic fundus camera. IDx-DR is an FDA-cleared
Read More

DreaMed Diabetes Granted FDA Approval for Personalized Diabetes Decision Support Solution

by Jasmine Pennic 06/18/2018 Leave a Comment

DreaMed Diabetes Granted FDA Approval for Personalized Diabetes Decision Support Solution

DreaMed Diabetes, an Israeli-based developer of personalized diabetes management solutions, today announced that the U.S Food and Drug Administration (FDA) has granted a De Novo request for DreaMed Advisor Pro, an artificial intelligence (AI)-based diabetes treatment decision support software. Advisor Pro is indicated to assist healthcare providers in the management of people with type 1 diabetes who use insulin pumps and continuous glucose monitoring (CGM).The announcement marks the second
Read More

Cardiac Monitoring Startup Eko Devices Raises $5M to Bring Intelligence to Heart Sounds

by HITC Staff 02/28/2018 Leave a Comment

Cardiac Monitoring Startup Eko Raises $5M to Bring Intelligence to Heart Sounds

Eko, a San Francisco, CA-based platform of non-invasive cardiac screening devices, care coordination software, and machine learning algorithms has raised $5 million in Series A funding led by ARTIS Ventures. The round also included participation from Strategic Partners, Dreamlt Ventures, 1812 Ventures, and FOUNDER.org. Eko plans to utilize the funding to accelerate its commercial team and to expand clinical studies on the use of Eko's platform for valvular heart disease screening and heart
Read More

Eko Duo Receives FDA Clearance to Market Combined Digital Stethoscope/ECG Smart Device

by Jasmine Pennic 06/07/2017 Leave a Comment

Eko Duo Receives FDA Clearance to Market Combined Digital Stethoscope/ECG Smart Device

Eko Devices, a provider of mobile acoustic cardiac monitoring solutions has received FDA clearance to market its latest solution, Eko Duo, a smart heart monitor transforming how patients and their physicians monitor heart disease. Eko Duo combines the digital stethoscope and ECG for monitoring patients in the clinic or at home into a compact, handheld device.The DUO, which patients can obtain with a prescription, can seamlessly stream cardiac data (stethoscope + ECG) to specialists, providing
Read More

Oxitone Medical Receives FDA 510(k) Clearance for Wrist-Sensor Pulse Oximetry Bracelet

by HITC Staff 05/17/2017 Leave a Comment

Oxitone Medical Receives FDA 510(k) Clearance for Wrist-Sensor Pulse Oximetry Bracelet

Oxitone Medical (Oxitone), an Israeli-based medical device and digital health company developing wearable monitoring solutions has received 510(k) clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The wrist-sensor pulse oximeter Oxitone 1000 measures critical vital signs such as SpO2 and pulse rate with the same precision as conventional fingertip pulse oximeters.The Oxitone solution has been validated in pilot studies in a number of medical settings including
Read More

  • Previous Page
  • Go to page 1
  • Interim pages omitted …
  • Go to page 8
  • Go to page 9
  • Go to page 10
  • Go to page 11
  • Next Page

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

Digital Health Funding Q3 2025: Choppy Undercurrents Beneath a Steady Surface

Most-Read

Qualtrics Acquires Press Ganey Forsta for $6.75B to Create the Most Comprehensive AI Experience Platform

Qualtrics Acquires Press Ganey Forsta for $6.75B to Create the Most Comprehensive AI Experience Platform

Pfizer and Trump Administration Announce Landmark Agreement to Lower Drug Costs

Pfizer and Trump Administration Announce Landmark Agreement to Lower Drug Costs

KLAS Report: Epic's Native Ambient Speech Tool Reshapes Customer AI Strategies

KLAS Report: Epic’s Native Ambient Speech Tool Reshapes Customer AI Strategies

Epic Unveils MyChart Central and New APIs to Advance Interoperability at Open@Epic

Epic Outlines Roadmap for Next-Generation Data Sharing at Open@Epic

Epic Launches Comet: A New AI Platform to Predict Patient Health Journeys

Epic Launches Comet: A New AI Platform to Predict Patient Health Journeys

RevSpring to Acquire Kyruus Health, Creating a Unified Patient Experience

RevSpring to Acquire Kyruus Health, Creating a Unified Patient Experience

Oracle Confirms Layoffs in Kansas City

Oracle Confirms Layoffs in Kansas City

Philips Future Health Index 2025: AI and Digital Tech Can Help Solve Cardiac Care Crisis

Philips Future Health Index 2025: AI and Digital Tech Can Help Solve Cardiac Care Crisis

Optain Health Secures $26M to Advance AI-Powered Retinal Screening

Optain Health Secures $26M for AI-Powered Retinal Screening

Sutter Health and Epic Launch "Sutter Sync" to Optimize Remote Chronic Care

Sutter Health and Epic Launch “Sutter Sync” to Optimize Remote Chronic Care

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |