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BioWorld - Sunday, January 11, 2026
Home » Topics » Medical devices » Wearable

Wearable
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Naox Link

Naox secures FDA clearance for EEG earbuds

Jan. 6, 2026
By Shani Alexander
Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.
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Kestra

Kestra follows IPO with $138M upsized offering

Dec. 3, 2025
By Annette Boyle
After raising more than twice as much as expected in its March IPO, Kestra Medical Technologies Inc. appears poised to repeat its success with an upsized secondary offering as well. The Kirkland, Wash.-based company initially planned to offer 5.5 million shares in its second pass at the market but increased the number of shares to 6 million two days later when it set the price at $23 per share. The projected gross proceeds of $138 million provide a nice addition to the $232 million raised nine months ago.
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Apple Watch pulseox

Analysts see tide turning toward Masimo in Apple patent war

Nov. 18, 2025
By Mark McCarty
A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.
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ReBalans hydration monitoring patch

Mode Sensors hydration monitoring system receives FDA clearance

Oct. 24, 2025
By Shani Alexander
Mode Sensors AS received U.S. FDA 510(k) clearance for its Re:Balans hydration monitoring system. The wearable patch sensor allows for the continuous monitoring of body hydration to detect fluid imbalances using thoracic bioimpedance technology to deliver automatic, accurate data to help physicians in fluid management.
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Gastric Alimetry

Alimetry brings first wearable gut diagnostic to market

Sep. 17, 2025
By Tamra Sami
Alimetry Ltd. is making waves far beyond its home market with its first-in-class wearable Gastric Alimetry device that measures gut function – an area long considered a black box in gastroenterology.
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Apple Watch pulseox

Apple reintroduces pulseox via software update

Aug. 14, 2025
By Greg Kaplan and Annette Boyle
Some Apple Watch users will be able to monitor their blood oxygen levels through their iPhone, thanks to a software update the company planned to issue Aug. 14. The Cupertino, Calif.-based company pulled the feature from its watches in the U.S. in 2024, following a patent dispute with Masimo Corp., of Irvine, Calif., that threatened an import ban.
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Trinity CGM+

Trinity unveils AI-powered CGM+ biosensor

July 28, 2025
By Shani Alexander
Trinity Biotech plc recently unveiled CGM+, an AI-native, wearable biosensor that goes beyond traditional continuous glucose monitors and tracks glucose levels, cardiovascular activity and body temperature at the same time. The company believes that as precision medicine becomes central to health care, especially with the collection of real-time data, CGM+ will become a critical enabler of AI-based diagnostics, behavioral coaching and chronic disease management.
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U.S. Capitol building, Washington D.C.

Remote patient monitoring shortchanged by Medicare

June 25, 2025
By Mark McCarty
A June 25 hearing in the U.S. House of Representatives highlighted some of the health care spending benefits of remote patient monitoring, but Medicare payment is seen as deficient – a problem that may be resolved by pending legislation.
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microfluidic patch pump
Patents

Researchers file patent for microfluidic patch-pump drug delivery platform

June 12, 2025
By Simon Kerton
Researchers from Virginia Polytechnic Institute and State University filed for protection of their development of a slim, painless, and affordable microfluidic infusion pump device for the continuous transdermal delivery of drugs.
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Doctor with illustration of kidneys

MFDS clears world’s first ECG-based AI kidney disease software

June 11, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
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