What You Should Know:
- Fitbit has received 510(k) clearance from the
FDA, as well as CE marking in the European Union, for its ECG
app to assess heart rhythm for atrial fibrillation. The Fitbit ECG App is a
simple way people can take an on-the-spot reading of their heart rhythm at any
time, including whenever they notice any unusual cardiac symptoms.
- Fitbit Sense is the company’s first device compatible
with an ECG app that enables users to take a spot
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FDA Clearance
Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation
What You Should Know:
- Caption Health AI is awarded FDA 510(k) clearance for
its innovative point-of-care ejection fraction evaluation.
- Latest AI ultrasound tool makes it even easier to
automatically assess ejection fraction, a key indicator of cardiac function, at
the bedside--including on the front lines of the COVID-19 pandemic.
Caption Health, a Brisbane,
CA-based leader in medical AI technology, today announced it has received FDA
510(k) clearance for an updated version of
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Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms
What You Should Know:
- The National Institutes of Health (NIH) has granted next-generation
cardiac AI company Eko an award totaling $2.7 million to support continued
collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute
- The grant will focus on validating algorithms and help
more accurately screen for heart murmurs and valvular heart disease during
routine office visits with Northwestern Medicine.
- By incorporating data from tens of thousands of
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Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery
What You Should Know:
- Digital surgery pioneer Activ Surgical raises $15M in funding led by ARTIS Ventures to accelerate U.S. commercialization and European expansion efforts for its ActiveEdge platform, which enables existing surgical systems, from scopes to robots, to visualize, characterize and track tissue, in real-time beyond today’s human capability.
- ActivSight, is an easy-to-adapt, connected imaging module that seamlessly attaches to today’s laparoscopic and arthroscopic
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Caption Health Nabs $53M to Commercialize FDA-Cleared AI-Guided Ultrasound Technology
What You Should Know:
- Caption Health raises $53 million series B round to
fuel commercialization and expansion of its FDA-approved AI ultrasound
technology. This is on the heels of its receiving FDA clearance, designated as
a breakthrough technology to fight against COVID-19.
- As ultrasounds, especially cardiac ultrasounds, have
become increasingly important during a time of COVID when resources are
stretched, using AI to help more healthcare professionals take high-quality
images is
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18 Healthcare Augmented Reality and Virtual Reality Companies to Watch
Augmented reality (AR) and virtual reality (VR) are redefining what's possible in healthcare, as well as other sectors. The 18 companies listed below are some of the top virtual and augmented reality companies in the medical industry.
Defining Augmented Reality
Augmented
reality is a technology that blends real-world elements with virtual ones. For
example, a person might visit a trade show and aim their smartphone at a
display to activate an AR experience that allows them to see
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Welldoc Awarded 8th FDA Clearance for Bluestar Medical Device for Diabetes
What You Should Know:
Marks 8th FDA clearance for BlueStar, the only
reimbursable software as a medical device for diabetes that integrates with all
of a patient's existing devices.
Welldoc, revolutionizing digital health with the first FDA-cleared Software as a Medical Device (SaMD) for diabetes, announced today that the U.S. Food and Drug Administration (FDA) has cleared an additional feature for the digital health product BlueStar Rx which supports individuals using long-acting
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Philips Awarded FDA Clearance for Wearable Biosensor to Monitor COVID-19 Patients
What You Should Know:
Wireless wearable biosensor (Philips Biosensor BX100) receives 510(k) clearance from the FDA and CE mark to help monitor COVID-19 patients in the hospital, with the first install at OLVG Hospital in the Netherlands
Philips Biosensor BX100 enhances Philips portfolio of devices, software, and services for identifying patients at risk for deterioration while limiting exposure to help improve staff and patient safety and preserve valuable personal protective equipment.
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Zebra Medical Vision Secures 5th FDA Clearance for Vertebral Compression Fractures AI Solution
What You Should Know:
- Israeli deep-learning medical imaging analytics startup Zebra-Med secures its fifth FDA clearance vertebral compression fractures AI solution for availability in the U.S.
- The AI solution will help health providers close the COVID-19-induced care gaps by identifying more patients at risk of osteoporosis, also known as the “silent killer,” costing over $52B in the U.S. alone.
- Zebra-Med is one of the first companies in the industry to provide an AI
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FDA Expedites Clearance for AI Ultrasound Solution to Fight COVID-19
What You Should Know:
- FDA expedites clearance of Caption Health’s AI-powered ultrasound solution to aid frontline healthcare workers in the fight against COVID-19 pandemic.
- Caption Health’s AI-guided imaging supports the assessment of cardiac function and decreases personnel exposure to novel coronavirus.
In response to the growing body of evidence demonstrating
the impact of COVID-19
on the heart, the U.S. Food and Drug Administration (FDA) has expedited
clearance of an update
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