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FDA Clearance

Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery

by Fred Pennic 07/16/2020 Leave a Comment

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

by Fred Pennic 07/15/2020 Leave a Comment

GE HealthCare to Acquire Caption Health

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

by HITC Staff 06/29/2020 Leave a Comment

Fundamental Surgery Becomes First VR Surgical Training Simulation to Gain CPD Accreditation

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

by Jasmine Pennic 06/04/2020 Leave a Comment

Welldoc’s BlueStar Integration with Xealth Improves Patient Engagement by 2.5X

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

by Fred Pennic 05/26/2020 Leave a Comment

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

by Jasmine Pennic 05/18/2020 Leave a Comment

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

by Fred Pennic 05/12/2020 Leave a Comment

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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Lumos Diagnostics Raises $15M to Expand Point of Care Diagnostic Solutions Internationally

by Jasmine Pennic 02/05/2020 Leave a Comment

Lumos Diagnostics Raises $15M to Expand Point of Care Diagnostic Solutions

- Lumos Diagnostics raises $15M in Series A funding to support the international expansion of its point of care diagnostic solutions. - Lumos provides assay development and manufacturing services for customized POC tests as well as directly develops, manufactures and will commercialize a suite of proprietary Lumos-branded POC tests that focus on the systemic host immune response. Lumos Diagnostics, a Sarasota, FL-based health IT company, today announced it has raised $15M in Series A
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Sony Awarded FDA Clearance for Smart Operating Room Platform in the U.S.

by Fred Pennic 01/30/2020 Leave a Comment

Sony Awarded FDA Clearance for Smart Operating Room Platform in U.S.

- Sony announces FDA 510(k) clearance from the FDA for NUCLeUS™, the smart operating room platform, for sale in the U.S. - NUCLeUS provides an enhanced, streamlined workflow for operating rooms and clinical spaces with direct access to imaging data from an easy-to-use central dashboard.  Sony Electronics has received FDA 510(k) clearance from the Food and Drug Administration for the company’s NUCLeUS™ Operating Room, Imaging Management and Collaboration Control platform. Proven in
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BioIntelliSense Awarded FDA 510(k) Clearance for On-Body Sensor for Scalable Remote Care

by Jasmine Pennic 01/28/2020 Leave a Comment

BioIntelliSense Awarded FDA 510(k) Clearance for On-Body Sensor for Scalable Remote Care

- BioIntelliSense announces FDA clearance of the BioSticker, the first single-use medical device enabling 30 days of continuous vital signs monitoring. - The FDA-cleared BioSticker medical device is designed to be discreetly worn on the upper left chest for effortless remote data capture and a simplistic “stick it on and forget it” patient experience.  BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its
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Featured Insights

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

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

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