Bernstein_Mazur

Transforming Health Care: The Drive For Digital Health and Health IT

By Stephen Bernstein, Lisa Mazur

…healthcare technology, a busy regulatory environment and evolving consumer demands have combined to shape today’s digital health space. Examining the interplay of those factors can give us a glimpse into…

…healthcare technology, a busy regulatory environment and evolving consumer demands have combined to shape today’s digital health space. Examining the interplay of those factors can give us a glimpse into…

Continue reading

Rogers-Headshot
Soapbox

Challenges Faced by Digital Therapeutics Developers

By Brian C. Rogers

…This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success. As a new technological course…

…This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success. As a new technological course…

Continue reading

FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff

…its guidance, “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)” to allow sponsors adversely impacted by…

…its guidance, “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)” to allow sponsors adversely impacted by…

Continue reading

Device Labeling MedAccred

MedAccred Program to Develop Labeling, Printing and UDI Audit Criteria Launched

By MedTech Intelligence Staff

Leading medical device original equipment manufacturers (OEMs) have launched a new MedAccred critical process focus area for Labeling, Printing, and Unique Device Identifier (UDI). The goal of the new program…

Leading medical device original equipment manufacturers (OEMs) have launched a new MedAccred critical process focus area for Labeling, Printing, and Unique Device Identifier (UDI). The goal of the new program…

Continue reading

Mobile apps

AHRQ Releases Technical Brief on Evaluation of Mental Health Apps

By MedTech Intelligence Staff

The Department of Health and Human Resources, Agency for Healthcare Research and Quality (AHRQ) has released a technical brief on the evaluation of mental health apps. The agency worked with…

The Department of Health and Human Resources, Agency for Healthcare Research and Quality (AHRQ) has released a technical brief on the evaluation of mental health apps. The agency worked with…

Continue reading

Leslie Trigg Outset Medical

Outset Medical CEO Elected MDMA Board Chair

companies, and this dynamic ecosystem is poised to solve some of the most pressing issues facing patient care in the years to come,” said Mark Leahey, president and CEO of…

companies, and this dynamic ecosystem is poised to solve some of the most pressing issues facing patient care in the years to come,” said Mark Leahey, president and CEO of…

Continue reading

Five Finalists of Annual Pediatric Medical Device Competition Announced

…and create faster pathways to commercialization. We congratulate this year’s finalists and look forward to seeing the progress made in the coming months as they navigate the accelerator program.” The…

…and create faster pathways to commercialization. We congratulate this year’s finalists and look forward to seeing the progress made in the coming months as they navigate the accelerator program.” The…

Continue reading

Mauricio Uribe

NDAs Remain a Potent Business Tool

By Mauricio Uribe

…has any type of discussion or interaction with external companies (e.g., finance companies, vendor, partners, contractors, etc.). NDAs typically mark the beginning of third-party interactions and will often define the…

…has any type of discussion or interaction with external companies (e.g., finance companies, vendor, partners, contractors, etc.). NDAs typically mark the beginning of third-party interactions and will often define the…

Continue reading

Rogers-Headshot

The Rise of Digital Therapeutics

…patients who are at risk of diabetes or obesity, to the complex, such as ingestible or implantable devices that communicate with a remote, external sensor to monitor medication efficacy. An…

…patients who are at risk of diabetes or obesity, to the complex, such as ingestible or implantable devices that communicate with a remote, external sensor to monitor medication efficacy. An…

Continue reading

Tommy Carls, Proprio
MEDdesign

How Both Low and High-Risk Innovations Play a Role as Change Agents

By Tommy Carls

…and scales new businesses unintentionally highlights this innovation squeeze. Many companies “develop a new product by digitally enhancing an existing one.” This approach is an example of incremental innovation where…

…and scales new businesses unintentionally highlights this innovation squeeze. Many companies “develop a new product by digitally enhancing an existing one.” This approach is an example of incremental innovation where…

Continue reading