Policy and Regulatory
1. New World Health Organisation Essential Diagnostics List released
The World Health Organisation has just released the new Essential Diagnostics List (version 3), which provides low- and middle-income countries with guidance on the most crucial diagnostics needed to tackle healthcare challenges.
2. England's NHS moves to boost access to Quidel, Roche, other medtech products
The Medtech Funding Mandate will boost access to Quidel and Roche’s placental growth factor-based preeclampsia tests, amongst others. The initiative designed to accelerate uptake of medical devices, diagnostics and digital products that lead to healthcare savings.
3. Belgium national insurances reimburses healthcare applications
One of the first applications to be reimbursed is the MoveUP coach which supports patients with knee and hip prostheses. Companies can apply to be reimbursed but must meet 3 levels of quality criteria.
4. FDA outlines plan for AI and Machine-based Learning Software
The agency will further develop a proposed regulatory framework, including through the issuance of draft guidance on a predetermined change control plan (for softwares learning over time).
5. French health authorities introduce new framework to evaluate organisational impacts (French)
Under the framework released in Dec 2020, health technologies can be evaluated for organisational impacts under 3 criteria: impact on healthcare processes, impact on capabilities of staff, impact on society.
Reimbursement Changes
1. New Norwegian Pathology and Activity Codes
Norwegian Pathology and Activity Codes have been recently updated for 2021. The update includes Activity Codes which allow for better and more comprehensive documentation of pathology activity. The Norwegian Directorate of Health will also establish a new activity-based funding scheme for outpatient pathology based on activity codes and provide updates when the funding scheme comes into force.
New Products, Partnerships, Discoveries
1. New online tool determines individual risk of colon cancer (in German)
A new German digital tool determines the individual risk of developing colon cancer in the next ten years, based on lifestyle factors. It was developed with the data of 200,000 individuals monitored for 15 years for cancer and validated with data from another 74,000 individuals.
2. Roche and Sysmex renew partnership for hematology testing
The long-standing agreement that allows Roche to continue to distribute Sysmex hematology products, including instruments and reagents and aims to help clinicians improve decision-making.
3. New study shows cost savings for full automation in microbiology lab
Amongst the results, specimen volume jumped from between 24% and 64% at every site, productivity increased ranging from 18% to 93%. Total labor savings ranged from $268,000 to $1,200,000 annually, equating to a cost per specimen decrease of between 15% and 47%.
3. Thermo Fisher scoops up Mesa Biotech for $450M
Mesa Biotech has developed a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV), and Strep A.
4. Connecting the Dots on Recent ECG Monitoring M&A Spree
Large medical device players are showing strong interest in the ambulatory ECG monitoring space. Here's a closer look at this industry trend, which discusses Boston Scientific’s acquisition of Preventice and Hillrom’s acquisition of BardyDx.
5. Teladoc Health, Dexcom Offers CGM-Powered Insights to People with Type 2 Diabetes
The new offering measures integrates Dexcom and Teladoc insights for more in-depth health visualisation. A pilot program was also initiated to measure the impact of continuous glucose monitoring insights.
6. Anthem launches new digital health incubator
American insurance company Anthem launches a digital health incubator to fast track promising solutions.
7. Gut microbiome predicts Nivolumab Efficacy in Gastric Cancer?
Preliminary data suggest that a certain pattern of gut microbes may be useful in predicting which patients with advanced gastric cancer are likely to benefit from treatment with the immunotherapy nivolumab (Opdivo).
8. Nottingham Medtech facility built to accelerate innovation
Nottingham Trent University has built a £23 million facility to develop new medical devices. The goal is to bring organizations, clinicians, and researchers together to get new medtech products to market quickly.
9. Google calls Fitbit acquisition complete despite ongoing DOJ review
Google said its acquisition of wearables giant Fitbit was complete, despite the fact that the $2.1 billion deal has yet to be approved by the U.S. Department of Justice. It committed not to use Fitbit data for search targeting.
General and studies
1. Genomic Data Analysis May Inform Prostate Cancer Risk Scores
In the largest, most diverse study of prostate cancer, researchers analyzed genomic data to refine risk scores and understand the role of genetics in health disparities.