Roche

By Dave Muoio 03:10 pm October 1, 2019
Sixth time's the charm? Roche’s Accu-Chek Connect Diabetes Management App has notched its sixth device recall from the FDA, this time due to meter-to-app data transfer issues for users with Android OS 8.0 and above. According to the agency’s posting, Roche notified partners, users and call centers of the issue and released and update addressing the problem before the end of that month. Prior to...

Screengrab of the Wellthy Therapeutics website.

By Dean Koh 11:28 pm June 12, 2019
At the 79th Annual Scientific Sessions of the American Diabetes Association in San Francisco, pharma giant Roche and India-based digital therapeutics company Wellthy Therapeutics presented real world data of improved diabetes care outcomes in a South Asian population when patients followed prescribed plan of medication and lifestyle modification in conjunction with a combination therapy of self-...
By Dave Muoio 12:09 pm June 4, 2019
Since it was first announced, fans and critics of the FDA’s Pre-Cert program for medical software developers have mused on the benefits and burdens that might come with participation in the experimental program. What to expect from Pre-Cert The question has only become more pertinent since the agency released its 1.0 Working Model in January and, just a couple weeks ago, began seeking new De Novo...

Credit: Foundation Medicine

By Dean Koh 02:46 am November 29, 2018
Roche announced last week the launch of FoundationOne CDx, Foundation Medicine’s comprehensive companion diagnostic test for personalised cancer care in Singapore. According to the official media release, FoundationOne CDx supports clinicians in their decision-making by providing a clear, in-depth report that describes the unique genomic profile of a patient’s tumour as well as associated,...
By Jonah Comstock 03:22 pm October 23, 2018
Update: This article has been updated to clarify potentially misleading claims about Novo Nordisk being first to market. Novo Nordisk has struck a deal with Flex Digital Health, part of the IoT logistics company Flex, formerly known as Flextronics. Novo Nordisk will use Flex's BrightInsight platform, which focuses on managing connectivity and compliance for regulated digital health devices, as it...
By Laura Lovett 12:10 pm June 11, 2018
As Pharma giant Roche continues its dive into the digital health realm, it is releasing a new self-testing device for INR or blood coagulation levels, that can wirelessly connect to a smartphone app. The CoaguChek Vantus system, which is designed for Warfarin patients to monitor their coagulation levels, includes built in Bluetooth technology. Patients can now see their results on the app and...
By Laura Lovett 02:16 pm June 8, 2018
The road to digital innovation in the pharma and healthcare space is going to take players across industries — from tech developers and engineers to researchers and clinicians, according to a panel of digital-focused VPs speaking at BIO 2018 in Boston.  Tech is opening up new avenues in research and development, as well as access to data from EHRs and other databases. In the past, the healthcare...
By Laura Lovett 01:13 pm April 25, 2018
Like almost any field in the healthcare industry pharma wants to get in on the latest technology trends. Recently big pharma has been looking to artificial intelligence as another tool to help facilitate drug research and help the company progress.  At the World Medical Innovation Forum in Boston on April 24, a panel of pharma leaders discussed the future of AI in the industry.  “It's quite top...
By Dave Muoio 03:55 pm February 20, 2018
Roche’s Accu-Chek Connect Diabetes Management App has hit yet another snag with the FDA. On February 15, the agency issued a Class 2 Device Recall for certain software versions of the app due to a bug that could lead users to self-administer inappropriate doses of insulin. Roche issued an update correcting the bug back in June, and has posted notices on the Accu-Chek website urging users to...
By Dave Muoio 04:49 pm February 15, 2018
Pharma giant Roche is set to acquire oncology EHR software firm Flatiron Health in the first half of 2018, the companies announced today in a statement. Roche will pay an additional $1.9 billion over the millions it had already invested into the company in 2016, and as a result of the deal will control all shares of Flatiron Health. “This is an important step in our personalized healthcare...