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Digital Health

Set Alert for Digital Health

DeepWell DTx Brings Mental Health To Meta Store

Zengence, the first virtual reality game intended to help reduce stress, became available earlier this summer. We talked to DeepWell DTx founder Ryan Douglas about the road ahead.

Digital Health Commercial

Clinicians: ‘Show Me The Impact And Outcomes Of AI Tools’

Royal Philips’ ninth annual Future Health Index global report reveals a growing acceptance by clinicians and health care stakeholders of virtual care and AI-enabled innovation. These tools can address workforce shortages, financial burdens and growing demand for care, said chief innovation and strategy officer Shez Partovi.

Leadership Artificial Intelligence

News We’re Watching: FDA Issues Monkeypox EUAs, IMDRF Publishes AI Principes, Quest Buys LifeLabs

This week, the US FDA authorized EUAs for at-home mpox tests and announced a public workshop on implanted brain devices; the IMDRF published guiding principles on good machine learning practices for AI; and Quest announced its deal to acquire a Canadian diagnostic firm.

Regulation Commercial

Class I Device For Methadone Dosing Decreases Costs, Save Lives

Sonara Health founder Michael Giles talks take-home methadone treatments, remote patient monitoring and sponsoring legislation to fund opioid treatment programs.

Behavioral Health Digital Health

News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation

This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.

Regulation Digital Health

Healthtech Leaders Discuss Impact (And Risks) Of Generative AI and AI In Health Care

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.

HLTH Artificial Intelligence

AI In Health Care: Speakers At HLTH Europe Conference Discuss Promise And Pitfalls

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.

HLTH Artificial Intelligence

Floreo CEO Champions FDA Path For Autism VR Therapy

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

Digital Health Reimbursement

‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More

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.

HLTH Artificial Intelligence

News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

Regulation Commercial

Outdated Technology Keeping Surgeons From Operating At Their Best: Medtronic Report

Cutting edge technology could significantly enhance operating room efficiency, according to a new report from Medtronic. The problem, however, is that most ORs don’t have it.

Artificial Intelligence Surgical Procedures

Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Digital Health Business Strategies

Industry Finds Innovative Revenue Streams For Digital Therapeutics

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

DTA Digital Health

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

News We're Watching Approvals

US, UK And Canada Collaborate On Transparency Principles For Devices Using Machine Learning

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

FDA Regulation

DTX Companies Find New Niche As Complement To Standard Of Care

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

Digital Health DTA
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