AI’s growing influence on the medical device company’s value chain

Here are examples of how your MedTech organization can use AI across the product lifecycle.

Sept. 16, 2024

Apple wins FDA nod for hearing aid software for certain Airpods

Apple is the first company to receive authorization for over-the-counter hearing aid software.

By Nick Paul Taylor • Sept. 13, 2024

Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech

New over-the-counter sensors, an Abbott-Medtronic partnership and Roche’s first CGM are among diabetes technology’s top stories so far in 2024. Check out MedTech Dive’s roundup of the latest news.

By Ricky Zipp • Sept. 11, 2024

Apple adding sleep apnea feature to smartwatch

Apple unveiled the health feature alongside new hearing aid capabilities for its Airpods Pro 2 earbuds.

By Nick Paul Taylor • Sept. 10, 2024

Many FDA-authorized AI devices lack validation data

About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.

By Elise Reuter • Sept. 9, 2024

AI still the most exciting emerging technology for healthcare: survey

AI was the most compelling new technology for the fourth year in a row, with leaders also saying the technology had shown the most improvement, according to the Center for Connected Medicine.

By Emily Olsen • Sept. 4, 2024

ARPA-H program to focus on AI degradation in medical tools

The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.

By Nick Paul Taylor • Sept. 3, 2024

Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator

The 13-week program will offer funding and guidance to up to 12 health tech, medtech and biotech startups working on AI tools.

By Emily Olsen • Aug. 29, 2024

Otsuka Precision Health launches first digital therapeutic for depression

Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.

By Elise Reuter • Aug. 14, 2024

Stryker to buy smart hospital technology firm Care.ai

The deal comes shortly after Stryker CEO Kevin Lobo told investors to expect a “very active deal pipeline” for the second half of 2024.

By Elise Reuter • Aug. 12, 2024

FDA officials outline benefits of AI lifecycle management

The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.

By Nick Paul Taylor • July 30, 2024

AI’s expert-level image analysis can be built on flawed rationales: study

Researchers at the National Institutes of Health found that a version of ChatGPT analyzed images at an expert level but frequently reached the right answer with incorrect reasoning.

By Nick Paul Taylor • July 25, 2024

Medtech firms have cut more than 14,000 jobs in the past 18 months

Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.

By Jasmine Ye Han , Ricky Zipp , Elise Reuter • Updated July 25, 2024

Roche wins CE mark for its first CGM

The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.

By Nick Paul Taylor • Updated July 10, 2024

Masimo offered up to $950M for consumer business

Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.

By Nick Paul Taylor • July 9, 2024

Senseonics tips 365-day CGM to double 2025 sales

Senseonics is in talks with insulin pump manufacturers about integrating its implantable Eversense continuous glucose monitor with their devices.

By Nick Paul Taylor • June 25, 2024

J&J creates open digital platform for surgical applications

J&J at first will focus on surgical video, telepresence and planning and limit access to select hospitals. It plans to make the platform more widely available in 2025.

By Nick Paul Taylor • June 21, 2024

ONC’s Micky Tripathi on laying the digital floor for healthcare AI

The agency head discussed ONC’s accomplishments over the past two decades, artificial intelligence opportunities and improving the documentation burden among clinicians.

By Emily Olsen • June 20, 2024

FDA official sets out approach to AI in medical devices

Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.

By Elise Reuter • June 18, 2024

Senators urge CMS to create AI payment pathway

Uniform reimbursement standards are needed to protect patient access to algorithm-based devices and ensure future innovation, the lawmakers said.

By Nick Paul Taylor • June 18, 2024

FDA creates transparency principles for AI in medical devices

The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.

By Nick Paul Taylor • June 17, 2024

Zimmer, RevelAi partner to sell AI tool for orthopedic care

RevelAi uses generative artificial intelligence to automate clinical workflows and support patients with conditions such as osteoarthritis.

By Nick Paul Taylor • Updated June 14, 2024

Stronger oversight of AI needed in medical devices, ECRI CEO says

Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.

By Elise Reuter • June 5, 2024

Dexcom connects G7 CGM directly to Apple Watch in US

Apple Watch and G7 users can now view real-time glucose readings on their wrist, regardless of whether they are carrying an iPhone.

By Nick Paul Taylor • Updated June 7, 2024

Digital therapeutics firm Akili to sell for $34M

Akili, which makes a video game treatment for ADHD, will merge with Virtual Therapeutics to create a larger digital health entity.

By Elise Reuter • May 30, 2024