What You Should Know:
- ENvizion, the FDA 510(k) cleared leader for enteral feeding
tube (EFT) navigation technology, has raised $18M for the ENvue
system, its “Waze”-like tool for the human digestive tract.
- ENvizion’s device enables nurses to navigate the
feeding tube with the help of a real-time 3D map of the patient’s actual body,
and its sensor warns if the tube has veered towards the lungs.
- The company is also partnering with one of the largest private
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
FDA Approves Medtronic’s Insulin Pump System for People with Type 1 Diabetes
What You Should Know:
- Medtronic announced the U.S. Food and
Drug Administration (FDA) approval of the MiniMed™ 770G hybrid insulin pump
system with smartphone connectivity and an expanded age indication to patients
with Type 1 diabetes aged 2 and up ― the lowest age indication by the FDA for
an automated insulin pump system.
- The new
MiniMed 770G system comes with the Guardian™ Sensor 34, the MiniMed™ Mobile app
(compatible with both iPhone and Android), and Roche Accu-Chek®
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XRHealth Appoints Deepa Javeri as Chief Financial Officer
XRHealth appoints Deepa Javeri as CFO and is significantly expanding their US headquarters.
XRHealth, a
Boston, MA-based provider of extended reality therapeutic applications and XR telehealth
services, today announced Deepa Javeri – a seasoned, global
financial expert and executive – has been named Chief Financial Officer
effective immediately. Javeri’s appointment comes at an exciting moment of
global growth and expansion for XRHealth.
“Deepa brings XRHealth a
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To Combat COVID-19, Philips Launches Rapid Equipment Deployment Kits
What You Should Know:
- Philips today announced the launch of its Rapid
Equipment Deployment Kits, which provide doctors with critical care patient
monitoring solutions they can quickly implement in the ICU. The Rapid Equipment
Deployment Kits use advanced patient monitoring technology to enable care teams
to swiftly scale up critical care capabilities within just a few hours, and
help hospitals meet on-demand access during these pressing times of COVID-19.
- Arriving at hospitals
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Medtronic Acquires Smart Insulin Pen Company Companion Medical
What You Should Know:
- Today, Medtronic announced that it will
acquire Companion Medical, the manufacturer of InPen, a smart insulin pen
system paired with an integrated diabetes management app.
- The addition of Companion’s InPen system builds
upon Medtronic's strategic acquisitions of Nutrino and Klue to further
improve overall automated decision-making capabilities and optimizes dosing
decisions using algorithms and AI for patients.
Medtronic,
today announced the
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FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer
What You Should Know:
The FDA and Syapse announce research collaboration expansion
to address urgent public health challenges including supporting FDA’s goal of
rapid understanding of COVID-19.
As part of the research, Syapse is partnering with FDA’s
Oncology Center of Excellence to investigate methods to derive RWD from
multiple sources including electronic health records, registries and molecular
data
Syapse, a real-world
evidence company accelerating the delivery of precision
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New Tech Solution Lets People Securely Share COVID-19 Testing Results
What You Should Know:
- TransUnion, in partnership with CLX Health, a joint venture from UST Global and SiriusIQ, announced the launch of HealthyAmerica, a technology solution that will give individuals the power to securely share their COVID-19 testing results while maintaining their individual privacy – helping businesses and schools across the country to minimize risk and reopen with greater confidence.
- Businesses and schools seeking to welcome back
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AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure
What You Should Know:
- Eko today announced a global collaboration with
AstraZeneca to accelerate the development of digital health tools for the
earlier screening of cardiovascular diseases, including heart failure.
- Through the collaboration, AstraZeneca and Eko will explore accelerating the development of Eko algorithms, enhancing clinical trials with Eko technology, and potentially building new heart failure detection solutions.
Eko, a digital health company
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Super-Spreading of COVID-19 Co-Infections Reveals a Deadly Diagnostics Gap
Secondary bacterial or fungal co-infections in COVID-19 patients have received inadequate attention from the public. For most, co-infections pose little to no risk according to reports that an estimated 8% of patients are found to experience this during hospital admission – a relatively low number compared to the global impact of the virus. However, once a patient enters a hospital for care or becomes ventilated while in the ICU, the risk for acquiring and spreading a deadly
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Philips Launches Pre-Hospital Wireless Monitoring Solution for Emergency Medical Response
What You Should Know:
- Philips receives 510(k) clearance from the FDA for its pre-hospital
wireless monitoring solution (Tempus LS- Manual), now offering its remote
monitor and defibrillator solution (Tempus ALS) to EMS customers in the U.S.
- Solution delivers real-time bidirectional data transfer
for remote patient monitoring, giving EMS responders a new approach to
pre-hospital care.
Philips, today announced the launch of its
remote monitoring and defibrillator solution
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