Conferences

The AI/ML pre-determined change control plan final guidance will include plans for agency-wide training for the implementation of PCCPs, an FDA deputy director said at the Medtech Conference.

CDRH is on track to meet its MDUFA V goals, seeing a steady return to pre-pandemic levels of device authorizations and submissions.

Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October. 

As diagnostics have become more technologically advanced and are used more frequently in detecting diseases, uniform regulatory standards have become necessary, according to a panel of experts discussing testing reform at the MedTech Conference in Boston.

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.

Exec Chat: Dexcom’s COO Jake Leach joined a panel discussion on the future of biosensing at CES 2024, where biowearables and glucose tech ranked among hot topics. He also spoke to Medtech Insight about plans for the company’s new CGM called Stelo, designed for people with type 2 diabetes who do not use insulin, Dexcom’s work with Apple to enable CGM users, and non-invasive monitoring prospects.

In this second roundup from CES, Medtech Insight shines the light on Proto Hologram’s many use cases in health care, Intuition Robotics’ ElliQ robot to help the elderly feel less lonely, MIT AgeLab’s Aging Suit, Siemens/Unlimited Tomorrow’s partnership on a bionic prosthetic arm, and Earable Neuroscience’s Frenz Brainband to promote better sleep.

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. 

Digital therapeutics aren’t going away anytime soon, but they are positioning themselves as a complement to traditional therapies.

At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.

Public and private payors at the Digital Therapeutics Alliance’s 2023 Inaugural Summit weighed in on the coverage environment for prescription digital therapeutics post-Pear Therapeutics and strategic moves companies can make to position themselves advantageously.

A panel discussion between health professionals, industry groups and digital therapeutics innovators at the DTA Summit highlighted opportunities and barriers for the development and adoption of digital therapeutics.

AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.

AI is all the rage these days, so it comes as no surprise that the topic of AI technologies ranked high during the panel discussions at the HLTH Europe event, held from 17-20 June in Amsterdam.

Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.  

Becton Dickinson is investing in high-growth segments and is on a mission to simplify its business. CEO Tom Polen’s 2025 strategy targets 25% operating margin from both innovations and durable core business combined, as senior BD executives told In Vivo during a break at J.P. Morgan 2024.

Exec Chat: Dexcom’s COO Jake Leach joined a panel discussion on the future of biosensing at CES 2024, where biowearables and glucose tech ranked among hot topics. He also spoke to Medtech Insight about plans for the company’s new CGM called Stelo, designed for people with type 2 diabetes who do not use insulin, Dexcom’s work with Apple to enable CGM users, and non-invasive monitoring prospects.

Exec Chat: UK consumer feedback has led to enhancements to the Lingo biowearable’s companion app to provide deeper, more personalized insight on the meaning of glucose spikes, as well as weeklong challenges to encourage healthy behavioral changes. While awaiting FDA clearance for a planned 2024 launch of Lingo stateside, Abbott also is exploring ways of accessorizing the Lingo sensor to make it more fashionable. Lingo Biowearables leaders Olivier Ropars and Ben Fohner discuss.

Medtech Insight covered the major announcements from medtech companies during the J.P. Morgan Healthcare Conference in early January. Here are a few more highlights from companies that may not have made the headlines but will, no doubt, make noise in 2024.