Coverage, Policy, Regulatory
1. NICE expands access to real-time glucose monitoring for diabetics
More than 250,000 people living with type 1 diabetes in the UK will be offered real-time continuous glucose monitoring (CGM) technology, reducing their reliance on fingerprick testing, according to NICE.
2. With IVDR looming, EU prioritizes guidance on legacy devices and Eudamed transition
With the IVDR date of application weeks away, the Medical Device Coordination Group (MDCG) has identified a pressing need for guidance on the regulation of legacy tests that continue to be placed on the market under the old directive and for advice on the transition to Eudamed, a medical device database being implemented as part of the incoming regulations.
3. Cohort for 2022 NHS Innovation Accelerator announced
The NHS Innovation Accelerator (NIA) has announced the 10 innovators who will receive support to introduce their solutions across England’s NHS over the next three years.
4. Fitbit Joins the AFib Detection Crowd with New Clearance
Google’s Fitbit is the latest company to receive FDA clearance for a wearable to detect atrial fibrillation.
5. Smartphone-based skin cancer diagnostic certified for use in UK
An artificial intelligence-powered digital tool for diagnosing skin cancers developed by Skin Analytics has been cleared in the UK as a Class IIA medical device, setting up broader use of the technology in patient assessments.
6. AI trial for bowel cancer care underway at 9 NHS trusts
The first UK clinical trial of an artificial intelligence (AI) device which has the potential to transform bowel cancer care is underway at nine NHStrusts.
Initiatives, companies, products
7. AstraZeneca Pushes Deeper into CDx Space with New Collaboration
AstraZeneca is making a bigger push into the companion diagnostics space. The pharmaceutical company is teaming up with Shanghai, China-based Amoy Diagnostics to develop assays.
8. Epic, Guardant Health team up for precision oncology
Guardant Health, which develops technologies for precision oncology, announced a new collaboration with Epic to integrate its portfolio of cancer tests within the Epic electronic health record.
9. AI-Powered Cancer Monitoring Test Launched Across Europe
C2i Genomics, a New York, NY-basedcancer intelligence company, launched its C2inform minimal residual disease (MRD) test across Europe after snagging CE-IVD marking in the European Union, the United Kingdom, and Switzerland.
10. LetsGetChecked adds whole genome sequencing with Veritas buy
LetsGetChecked, a specialist in at-home diagnostic testing, has added genomics to its technology base with the acquisition of Veritas for an undisclosed amount.
11. Abbott joins alliance to bring ‘artificial pancreas’ system to Europe
Abbott has joined forces with two other companies, Camdiab (mobile app, and Ypsomed (insulin pump), to bring an automated insulin delivery (AID) system to people with diabetes in Europe that will monitor blood glucose levels and deliver insulin automatically.
12. Dexcom's Savvy Business Move into New Geographies
The company is getting ready to launch the Dexcom One in the United Kingdom in May. While it doesn't have all the bells and whistles that the G7 offers, the Dexcom One is intended to be a more affordable and accessible option for people with diabetes. It also represents a very intentional business move for Dexcom.
13. Fujifilm develops AI tech for predicting Alzheimer's progression
Fujifilm Corporation has developed AI technology that can predict whether patients with mild cognitive impairment will progress to Alzheimer's disease within two years.
14. AI tool which can detect heart disease being used at Royal Free Hospital
During an MRI heart scan, the AI tool is deployed to detect evidence of heart disease in a process that takes just 20 seconds. In comparison, it takes around 13 minutes for a doctor to manually assess an MRI.
15. Biofourmis reaches unicorn status with $300M Series D
AI-backed remote monitoring and digital therapeutics company Biofourmis raised a whopping $300 million in Series D funding, boosting the company to unicorn status with a valuation of $1.3 billion.
16. Value-based care focused health analytics startup Clarify Health scores $150M
Clarify Health is focused on the value-based care space. The company uses its cloud-software product to help plans create "value-based care contracts, manage financial performance and digitize settlements."