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Roundup: AI-Powered Assistive Hearing Devices Scream With Personalization; Femtech From Baby Makers To Menopause

 
• By Marion Webb

In this first of a two-part roundup from CES, Medtech Insight tunes into two companies that developed assistive hearing devices, OrCam Hear and Concha Labs, and three women’s health companies focusing on menopausal symptoms and an app to track the “baby-making” journey. 

CES 2024
• Source: Medtech Insight

CES 2024 was dominated by artificial intelligence and tech solutions to better our lives and included many solutions in the health and wellness space too. Below is the first of two roundups of some of the most interesting new devices seen, and in some cases demoed, by Medtech Insight at this year’s biggest tech event, which was held from 9-12 January in Las Vegas. (Also see "Preview Of HealthTech At CES 2024: MagicMirror Of Health; Hologram Surgeon; Loud Whispers" - Medtech Insight, 8 January, 2024.)

The landmark over-the-counter hearing aid legislation passed in 2022 in the US has catapulted a wave of start-ups introducing over-the-counter...

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More from In Vitro Diagnostics

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

More from CES

CES 2025: Ever-Growing Digital Health Programming Brings DTx, Smart Homes, AI, AgeTech, Home Health, Wearables To Venetian

 
• By Marion Webb

Medtech Insight spoke with René Quashie, vice president of digital health at the Consumer Technology Association (CTA), about what to expect at this year’s CES show.

Pickleball, Smart Homes, Brain Games, Caregiving AgeTech Take Centerstage At AARP’s CES 2025 Presence

 
• By Marion Webb

AARP returns to CES 2025 with pickleball court, 13,000-square-foot booth, up to 30 start-ups in AgeTech Collaborative showcasing innovations for brain health, active living, caregiver solutions, programming, and more.

Digital Health Roundup: CES Biggest Hits; Apple Versus Masimo; Insulet Recalls Diabetes App

 
• By Marion Webb, Hannah Daniel, and Brian Bossetta

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with industry leaders in medtech and healthtech and demos of some of the most innovative tech seen at CES 2024 in Las Vegas. Hannah Daniel dives into the latest developments in the intellectual property dispute between Apple and Masimo over blood oxygen sensors in the newer Apple Watch models.