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...
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,...
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...
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...
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...
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...
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...
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...
Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras...
As implantable CGM company Senseonics continues to wait for clearance from the FDA, the company isn't sitting on its hands. On a Q2 earnings call, CEO Tim Goodnow reported that the company continues to expand its operations in Europe, is close to a CE Mark for a longer-lasting second generation device, and is partnering with Roche and Type Zero on an artificial pancreas study with an eye on...
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