Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

August 2021: What’s new in the world of diagnostics?

Coverage, Policy, Regulatory, Guidelines

1.       NICE launches consultation on health tech assessment

NICE is seeking feedback in several areas including how make the processes of health technology evaluation more flexible and responsive. The consultation is open till Oct 13.

2.       German Health Ministry not satisfied with status of price negotiations for digital health apps

Since Germany’s official scheme for evaluating health apps for reimbursement took off last year, 89 health apps have applied, only 20 have been approved and 42 were withdrawn.

3.       Changing Medical Devices Regulations in UK and Europe

Companies that have already registered their devices in the EU will still be able to sell their products in Great Britain until June 2023. From this point, they will be required to register their device for UK Conformity Assessed (UKCA) marking.

4.       Glioma: New German S2k guidelines for diagnosis and therapy in adulthood

In addition to standard diagnostics with magnetic resonance imaging and histology after surgery or by biopsy, the guideline particularly addresses molecular diagnostic criteria.

Companies, new products, joint ventures

1.       Google Health is history but its projects to continue

The tech giant plans to dissolve its health division with the departure of leader Dr. David Feinberg. But Google maintains that healthcare is still a big focus for the company, and that the division’s projects and staff would continue under other leaders.

2.       Mayo Clinic, Alphabet's Verily partner to build clinical decision support tools

Cardiovascular and cardiometabolic diseases will be the initial focus.

3.       BD results call mixed amid bullish COVID-19 testing outlook

Third fiscal quarter revenues were $4.9 billion, growing 26.9% year over year on a reported basis driven by its base business. However, margins on Covid testing were weaker than expected.

4.       European Commission Doubles Down on Illumina/Grail Merger

The European Commission is challenging Illumina’s recent decision to acquire Grail without first securing EU antitrust approval.

5.       Switzerland's Digital Health Engagement Institute launches to improve health and lifestyle choices

International professors and experts have collaborated to help prevent non-communicable diseases (NCDs) through lifestyle navigators and wellbeing apps..

6.       Screening test for 50 genes passes another test

A new study shows that false positives can be largely avoided in Grail’s liquid biopsy test

7.       Foundation Medicine, Epic collaboration focuses on genomics for precision oncology

Physicians will be able to directly order Foundation Medicine’s genomic profiling assays through the Epic electronic health record systems.

8.       Abbott’s FreeStyle Libre 2 snags FDA clearance to help patients manage diabetes

The new system can be used with Apple iPhones and lets users check their glucose without needing a reader.