Coverage, Policy, Regulatory
1. MedTech Europe welcomes application of IVDR
The application of the In Vitro Diagnostic Medical Devices Regulation (IVDR) on 26 May 2022 marks an important new chapter for in vitro diagnostic (IVD) medical tests in Europe. However, the incomplete IVDR infrastructure poses critical ongoing risks that need urgent resolution.
2. Approved health apps are not yet effective (DiGA)
Based on an evaluation of the the Central Institute for Statutory Health Insurance Physicians (ZI), Less than one percent of patients who are entitled to use an approved health app according to their indication have so far received a prescription for such a digital health application (50'112 DiGA subscriptions in a motential market of 33.66 M patients, 0.15% of the total)
3. Sleepio becomes first digital therapeutic to receive NICE guidance
In its guidance, NICE states the app, created by digital therapeutics (DTx) firm Big Health, is a safe and effective treatment for people suffering from insomnia.
4. Up to half a million pounds of funding available for NHS digital projects
NHS organisations are being invited to apply for funding of up to £500,000 to support digital projects that can support patients at home. The awarded funding can be used to support the deployment of digital health technologies – including their development; initial feasibility with a plan to build a project; and innovation scaling within clinical pathways.
5. Reinhardt wants to demand GOÄ reform at the German Medical Association
The "clear demand" for an amendment to the fee schedule for doctors (GOÄ) will be articulated in the direction of politics. This was emphasized by Klaus Reinhardt, President of the German Medical Association. (BÄK)
6. Singapore's PRECISE partners with Illumina for large-scale population health study
The project, titled SG100K, will sequence and analyse the genomes of about 100,000 consenting participants around Singapore with Chinese, Malay, and Indian backgrounds, representing about 80% of the population across Asia.
7. Digital health body publishes best practice guide for DTx developers
The DTx Value Assessment & Integration Guide lays out the Digital Therapeutics Alliance's (DTA) thinking on how developers can clinically evaluate DTx products, meet regulatory requirements to get them approved, and ensure their quality and security.
Initiatives, companies, products
8. Illumina Obtains CDx Pan-Cancer Indication for TruSight Test
This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer.
9. New Algorithm Gives Digital Pathology a Boost
Researchers from Boston University School of Medicine (BUSM) have developed an artificial intelligence (AI) algorithm based on a framework called representation learning to classify lung cancer subtype based on lung tissue images from resected tumors.
10. Verily advances smartwatch toward Parkinson's clinical trial use after validating technology
Researchers have generated evidence that Verily’s wearable device can record measurements that may serve as digital biomarkers of Parkinson’s disease progression.
11. Abbott's Libre 3 glucose monitor gets FDA clearance as CGM market intensifies
Securing the clearance gives Abbott a head start on Dexcom’s rival next-generation CGM — the G7 system — which is expected to receive clearance from the FDA in June or later. Abbott is focusing on accuracy, size and affordability as it makes its case for Libre 3 over devices from competitors.
12. Kaiku Health partners with Roche to deploy digital cancer management tools
Digital cancer care company Kaiku Health has entered into a strategic partnership with pharma and diagnostics giant Roche to offer Kaiku's tools for symptom management and support to clinics and patients.
13. FDA clears Abbott's 4-in-1 Alinity PCR test for sexually transmitted infections
The FDA clearance covers Abbott’s Alinity m STI Assay, a multiplex test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG).
14. Medtronic aims to improve the colonoscopy with AI
One study in particular published in The Lancet Digital Health last month found that using Medtronic’s AI-powered system called GI Genius with a colonoscopy increased colorectal cancer prevention by nearly 5%
15. Takeda, Daiichi-backed wearable study planned in Japan
A study that will look at the feasibility of tracking people’s lifestyle habits for an extended period using a wearable device has got underway in Japan, backed by drugmakersTakedaand Daiichi Sankyo.