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

WellDoc Receives FDA 510(k) Clearance for Non-Prescription Version of BlueStar® Digital Therapeutic

by HITC Staff 01/19/2017 Leave a Comment

WellDoc

Digital health leader WellDoc has received FDA 510(k) class II clearance for a non-prescription version of the BlueStar® digital therapeutic diabetes management platform. This news comes on the heels of two other significant recent announcements for BlueStar®: the FDA’s clearance of the wireless integration of LifeScan’s OneTouch Verio Flex® blood glucose monitoring system with BlueStar®, and plans to incorporate the American Association of Diabetes Educators’ (AADE) curriculum in the BlueStar®
Read More

MOCACARE Unveils FDA-Approved Wireless Blood Pressure Monitor

by Jasmine Pennic 11/21/2016 Leave a Comment

MOCACARE Unveils FDA-Approved Wireless Blood Pressure Monitor

MOCACARE, a Silicon Valley based company has launched MOCACuff, a FDA-approved wireless blood pressure monitor that fits comfortably on the wrist. Priced at $69.99, MOCACuff is the second product in the MOCACARE line that makes it easy to incorporate blood pressure monitoring into your everyday routine and receive instant, actionable insights to improve your health.MOCACARE first product, MOCAheart device uses thumb scans to measure heart rate, blood oxygen levels, and pulse wave velocity - a
Read More

AirStrip Granted FDA 510(k) Clearance, Patent for AirStrip ONE App

by Jasmine Pennic 09/21/2016 Leave a Comment

AirStrip Granted FDA 510(k) Clearance, Patent for AirStrip ONE App

AirStrip announced it has received FDA 510(k) clearance to a web client for the AirStrip ONE® mobile interoperability platform and app that can be run on desktops and laptops using Internet Explorer and Google Chrome. AirStrip ONE® provides a single, data- and vendor-agnostic platform that connects clinicians with the right information at the right time, via the most convenient device at hand.The company also recently received a U.S. patent for new functionality: ECG waveform 'visual calipers'
Read More

FDA, Flatiron Health Team Up for Cancer Research Initiative

by HITC Staff 05/26/2016 Leave a Comment

Is Artificial Intelligence the Key to Curing Cancer

Flatiron Health and the FDA have teamed up on a new research collaboration agreement to determine how real-world evidence derived from de-identified, HIPAA-compliant patient data captured outside of clinical trials can provide new insights into the safety and effectiveness of emerging anti-cancer therapies such as immunotherapeutic agents.Research Initiative DetailsAs part of this research initiative, Flatiron Health and the FDA are collaborating on a project to investigate the use of
Read More

Senate Health Commitee Confirms New FDA Head Dr. Robert Califf

by HITC Staff 02/24/2016 Leave a Comment

FDA Commissioner nominee Califf testifies at nomination hearing in Washington

Senate health committee today confirmed President Obama's nominee Dr. Robert Califf to be the new commissioner of the Food and Drug Administration (FDA) in a vote of 89 to 4. The vote comes after over a month of opposition from Senate over the FDA's response to prescription painkiller abuse. Dr. Califf, a cardiologist and clinical researcher from Duke University, has been a consultant to drug companies was meet with resistance from Democrats who felt his ties to drug companies would be a
Read More

Report: Life Sciences M&A and the Rise of Personalized Medicine

by Fred Pennic 11/09/2015 Leave a Comment

Life Sciences M&A and the Rise of Personalized Medicine

As the life sciences (pharmaceuticals, biotechnology and medical sectors) M&A reaches new heights, there seems to be no end in sight for life sciences companies' hunger for acquisitions. 94% of life sciences companies are planning to make an acquisition in the next year, with 91% of US respondents expecting these to be cross-border transactions, according to a global study of 100 senior executives at life sciences companies by global law firm Reed Smith, commissioned by Mergermarket.  The
Read More

20 Promising Canadian Digital Health Companies to Watch

by Komal Garewal 07/08/2015 Leave a Comment

Canada ICD-10 Transition

“A company’s odds of success are better the closer they can get to their market,” argues Stephen Hurwitz, a thought leader in the Canadian venture capital industry, recognizing that the proximity to a VC-tech hub can help the success rate of Canadian startups. A socialized healthcare system, Canada’s market is fragmented by province and type of care – most primary and emergency care is free for residents whereas specialty care, prescription drugs, long-term and in-home care amongst others,
Read More

Pages: Page 1 Page 2 Page 3 Page 4

4 Mobile Health Challenges for Medical Device & Diagnostic Firms

by Bernhard Kappe, Founder & CEO of Pathfinder Software 12/03/2013 2 Comments

4 Mobile Health Challenges for Medical Device & Diagnostic Firms

Bernhard Kappe, Founder & CEO of Pathfinder Software outlines four key mobile health challenges for medical device & diagnostic firms. 
Read More

Specialty Article: Growing Pains: Medical Device Interoperability

by Fred Pennic 06/27/2011

Specialty Article: Growing Pains: Medical Device Interoperability

Both provider organizations and medical device vendors have made significant, if slow-going, progress over the last several years to network their digitally-enabled medical devices. Recent strides in both the regulatory and standards arenas have provided renewed impetus on the part of both stakeholder groups to bring more interoperability to disparate medical devices, resulting in better security and quality of patient data.As healthcare providers continue their steady march toward implementing
Read More

  • Previous Page
  • Go to page 1
  • Interim pages omitted …
  • Go to page 38
  • Go to page 39
  • Go to page 40

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Interview

Reach7 Diabetes Studios Founder Chun Yong on Reimagining Chronic Care with a Concierge Medical Model

Most-Read

HHS Finalizes HTI-4 Rule: Prior Authorization & E-Prescribing Interoperability

HHS Finalizes HTI-4 Rule: Prior Authorization & E-Prescribing Interoperability

Meaningful Use Penalties_Meaningful Use_Partial Code Free_Senators Urge CMS to Establish Clear Metrics for ICD-10 Testing

CMS Finalizes TEAM Model: A New Era of Value-Based Surgical Care

White House Event Unveils CMS Health Tech Ecosystem Initiative

White House Event Unveils CMS Health Tech Ecosystem Initiative

Digital Health Faces Q2'25 Pullback: Funding Falls to 5-Year Low, But AI Dominates and $1B+ IPOs Emerge

Healthcare Investment Shifts in 1H 2025: AI Remains a Bright Spot Amidst Fundraising Decline

Digital Health Faces Q2'25 Pullback: Funding Falls to 5-Year Low

Digital Health Faces Q2’25 Pullback: Funding Falls to 5-Year Low

Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option

Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option

Health IT Sector Navigates Policy Turbulence with Resilient M&A

Health IT’s New Chapter: IPOs Return, Resilient M&A, Valuations Rise in 1H 2025

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

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 |