January 2, 2020
On Apple and patents. A New York University School of Medicine cardiologist is unhappy with Apple Watch’s heart rate irregularity detection feature, which he claims in a new lawsuit infringes his own patent for atrial fibrillation detection technology. Filed in the US District Court for the Eastern District of New York on December 27, 2019, the suit describes Dr. Joseph Wiesel’s invention and his...
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.
Screengrab of the Wellthy Therapeutics website.
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-...
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
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,...
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...
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...
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...
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...
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...