Policy and Regulatory
1. Changes in the Swiss Analysenliste (dx reimbursement list) effective Dec 1 (in German)
Generally, prices for many nucleic acid amplification assays have been reduced. Subcodes with lower reimbursement rates have been introduced for multiple/combined pathogen testing.
2. EU regulators provide 7 rules for classifying diagnostics under IVDR
The European Commission's Medical Device Coordination Group has published guidance on the classification rules for in vitro diagnostics under the incoming regulations.
3. UK fleshes out post-Brexit approach to regional medical device marking
The U.K. has created a new conformity marking, UKNI, that may be used to show certain products meet the relevant rules.
4. NICE is getting ready for the end of the transition period after Brexit
NICE is working with regulators to design a new process for medicines and medical devices evaluation post-Brexit. It remains engaged in EU initiatives like EUNetHTA.
5. German Law on the digital modernization of supply and care (in German)
New digital applications (DiPAs) are to be introduced in healthcare, the supply of digital health applications (DiGAs) is being further developed, telemedicine is being expanded and made more attractive.
New Products, Partnerships, Discoveries
1. NHS to pilot potentially revolutionary blood test that detects more than 50 cancers
The Galleri blood test, developed by GRAIL, can detect early stage cancers through a simple blood test, and will be piloted with 165,000 patients in a world-first deal struck by NHS England.
2. AliveCor Brings in $65M to Accelerate Growth of Remote Cardiology Platform
Its AI-powered ECG determinations will be strengthened with telehealth services, detection and condition management services for providers and institutions. Furthermore, it will team up with Omron for hypertension management.
3. Medtronic launches CGM-integrated smart insulin pen for multiple daily injections
It provides a complete picture for users as they look to give themselves the right dose of insulin at the right time.
4. BD Announces Streamlined Reporting Capabilities for COVID-19 Data
The BD Synapsys™ solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor™ and/or BD MAX™ systems
The TwinStrand Duplex Sequencing™ technology enables researchers and clinicians to detect faint signals of ultra-low frequency DNA mutations often obscured by technical noise.
The program is split into two tracks, one for early-stage companies and another for more experienced companies. Caria, a menopause solution and Elly Health an audio companion for chronic disease are in the early stage track, whilst genome testing company Decipher Biosciences and diabetes solution Sweetch are on the other track.
7. Google rolls out AI tools to review unstructured medical text
The goal is to make it easier to pull in important information that might not be in the structured fields of a medical record, but are instead buried in free text notes
8. Holmusk & Merck partner to improve treatment outcomes for prediabetes & diabetes patients in APAC
The partnership will leverage on Holmusk’s GlycoLeap platform to help patients achieve weight loss and improved blood glucose control.
General articles and medical studies
1. Diagnostics: A new era begins
Viktor Kölzer, Professor of Computer-Aided Image Analysis in Pathology at the Zurich University Hospital explains how AI will change diagnostics in future
This study shows that a prediction of RNA expression classifiers can be made from H&E (hematoxylin and eosin)images, opening the door to simple, cheap and reliable biological stratification within routine workflows.