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BioWorld - Tuesday, December 23, 2025
Home » Topics » Medical devices » Digital health

Digital health
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Gold coins and sprouting plants

Goodpath accelerates AI development following $18M series A

Sep. 12, 2025
By Holland Johnson
Goodpath Inc., a virtual provider of whole-person care for chronic conditions, raised $18 million in series A financing, led by Massmutual Ventures with participation from Healthy Ventures and current investors.
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Eko Health AI stethescope

Eko’s AI-stethoscope more than doubles heart disease detection

Sep. 11, 2025
By Annette Boyle
In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid.
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EU flags at European Commission building
LSI Europe

Opportunities remain in the EU for med tech despite US shift

Sep. 11, 2025
By Shani Alexander
Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.
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Respiree system

FDA gives nod to Respiree wearable for home care

Sep. 5, 2025
By Tamra Sami
The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.
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Medicare puzzle

OIG presses for scrutiny of remote patient monitoring

Sep. 3, 2025
By Mark McCarty
The Office of Inspector General recently reported that billings for remote patient monitoring eclipsed the $500 million mark in 2024, but the agency stated that more scrutiny will be necessary going forward to keep waste, fraud and abuse at bay.
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Mental illness art concept

Greymind AI’s mental health platform offers 24/7 counseling

Aug. 29, 2025
By Tamra Sami
Patients often wait for a long time to see a mental health specialist to get the help they need, and Greymind AI’s mental health platform, Reboot AI, offers a stop-gap measure to provide structured early intervention with built-in escalation to human clinicians.
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Aivis

Aivis’ Qanti IHC uses AI to visualize biomarkers in cancer care

Aug. 25, 2025
By Marian (YoonJee) Chu
Lee Dae-hong founded Aivis Inc. in January 2021 as an AI-powered pathology software company, having led the development of the world’s first commercial under-display fingerprint recognition algorithm that was later incorporated into the Galaxy S10 and Galaxy A series of smartphones of Samsung Electronics Co. Ltd.
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Digital spine concept art

Aclarion's Nociscan nearly doubles spine surgery success

Aug. 22, 2025
By Annette Boyle
Aclarion Inc.'s Nociscan, an AI-augmented platform that leverages MR spectroscopy to noninvasively identify the discs causing low-back pain, enables precise targeting of surgical intervention, resulting in 97% success. That’s roughly double the rate of 48% to 54% seen in conventional procedures for discogenic lower back pain, Aclarion CEO Brent Ness told BioWorld.
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Artryas Salix

FDA clears Artrya’s Salix AI coronary plaque module

Aug. 22, 2025
By Tamra Sami
The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.
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Signots Stelo

Signos adds AI to CGM to drive weight loss

Aug. 21, 2025
By Annette Boyle
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
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