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FDA clears Eko stethoscope AI to catch low ejection fraction

Posted on April 7, 2024

Developed in collaboration with the Mayo Clinic, the software can detect a key indicator of heart performance through Eko’s digitally enhanced stethoscopes.

Read the full article at: www.fiercebiotech.com

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20 Ways to Leverage AI in Medical Devices

Posted on April 6, 2024

Medical device engineers and artificial intelligence tech experts take to LinkedIn to tout the advantages of AI in medical devices and engineering.

Read the full article at: www.mddionline.com

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Abbott’s TriClip heart implant receives FDA approval for tricuspid valve repair

Posted on

TriClip reinforces the valve separating the heart’s right atrium and ventricle by grasping together its flaps and forming a tighter seal.

Read the full article at: www.fiercebiotech.com

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Abbott advances its hand-held, rapid blood test for TBI, concussions with new FDA clearance

Posted on

You won’t see Abbott’s i-STAT Alinity test on the sidelines of sporting events just yet—but the FDA’s green light is a step in that direction.

Read the full article at: www.fiercebiotech.com

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Deka-designed, Tidepool-powered auto insulin pump clears FDA

Posted on

Designed by Dean Kamen’s Deka R&D and connected with Tidepool’s artificial pancreas software, the upcoming twiist pump has received the go-ahead from the FDA.

Read the full article at: www.fiercebiotech.com

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BD boosts US production as FDA warns against using plastic syringes from China

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The FDA last week re-upped its recommendations that healthcare providers avoid using plastic syringes made in China wherever possible.

Read the full article at: www.fiercebiotech.com

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Masimo to hive off consumer business, including FDA-cleared baby monitor, health smartwatch

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Masimo will form a new company to house its home audio brands plus its high-tech Stork baby monitor system and its health-focused smartwatches.

Read the full article at: www.fiercebiotech.com

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Innovating Healthcare: The Critical Role of Prototyping in Medical Device Creation

Posted on February 28, 2024

Omnica Corporation

Medical device prototyping is crucial in developing safe, effective, and market-ready healthcare solutions. It involves constructing tangible, physical representations of the device to assess its design and performance before mass […]

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Deciphering In Vitro Diagnostics: The Future of Medical Testing

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Omnica Corporation

In vitro diagnostics (IVD) are medical tests performed on samples taken from the body such as blood or tissue in a controlled laboratory. These evaluations help healthcare professionals diagnose diseases, […]

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FDA Roundup: February 2, 2024 | FDA

Posted on February 4, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Read the full article at: www.fda.gov

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Our specialized resources and experience enable us to build almost any medical device, and we have been doing so for nearly three decades. Omnica has partnered with startups and industry leaders alike to deliver world-class results that speak for themselves.

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Jorg Lorscheider

Jorg Lorscheider is the director of sales and marketing at Omnica and has been involved in product development and manufacturing for over 25 years.

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