Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

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

Coverage, Policy and Regulatory

1.       As EU-wide HTA oversight law nears passage, industry is not pleased

Negotiators for the European Parliament and Council recently reached an agreement on the HTA regulation, intended to support cross-border cooperation on the assessment of the value of health technologies.

2.       Switzerland: Tardoc: New proposal in the big wage dispute

The Federal Council recently rejected the new tariff system Tardoc in its current form for approval. The collective bargaining partners have time until the end of the year to propose an improved tariff system for billing outpatient services in the amount of CHF 12 billion.

3.       US: CMS again passes on national pricing for long-term cardiac monitoring, dramatically reduced rates remain

CMS asked for further public comments regarding pricing information in the proposed calendar year 2022 Physician Fee Schedule, released Tuesday, as the industry has expressed concern that rates are below the cost of providing the devices and services.

4.       German MoH embarks on digital maturity assessment with HIMSS and partners

This move follows Germany’s Federal and State governments investing up to €4.3 billion in the digital infrastructure of the country’s 1,800 hospitals. (Hospital Modernization Law)

5.       France: Digital Health: around € 500 million for software equipment for healthcare establishments and professionals (DNS)

Funding for digital Segur is divided into two components: an equipment component and a usage component. They provide incentives (funding for publishers and users) and coercive (enforceability for publishers, data sharing obligations for establishments and health professionals), it should be remembered.

6.       UK: Accelerating the adoption of innovation in the NHS

Presented at this year’s NHS Confederation Conference, the study found that long-term collaboration, relationship building, and tailoring approaches to local organizations were the keys to moving new interventions from the drawing board into routine practice.

7.       UK: New screening service to identify children at risk of heart disease

Over the next two years, 30,000 children across England will be assessed to identify if they have a gene that causes familial hypercholesterolemia (FH), an inherited condition passed down through families which can lead to extremely high cholesterol levels.

New Products, Partnerships, Discoveries

1.       Illumina-Grail merger subject of in-depth EU antitrust probe

European officials are probing the deal because of concerns it “may reduce competition and innovation in the emerging market for the development and commercialization of cancer detection tests based on sequencing technologies."  The U.S. Federal Trade Commission in March moved to block Illumina's takeover of Grail on similar grounds.

2.       Unilabs and Ibex to implement AI cancer platform in Europe

Unilabs, a provider of diagnostic services, and Ibex Medical Analytics, a specialist in artificial intelligence-powered cancer diagnostics, have signed a deal to implement Ibex’s AI platform in Europe.

3.       Aptar makes digital health play, agreeing deal to buy Voluntis

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year.

4.       South Korean AI startup Lunit scores $26M investment from Guardant Health

The investment came from Guardant Health.

5.       AliveCor gets FDA clearance for feature to measure QT interval

AliveCor, a company that makes at-home EKG devices, recently received 510(k) clearance for a feature that could help physicians detect if medications are affecting a patient’s QT interval.

6.       Merck, Evidation to test if smartphone data can be used to detect early Alzheimer’s

Merck is partnering with digital health startup, Evidation, to see if smartphone data can be used to identify digital endpoints for Alzheimer’s drug development.

7.       Viz.ai Wins CE Mark for AI Stroke Solution

Viz.ai’s flagship solution, Viz LVO, uses AI to automatically detect suspected large vessel occlusion (LVO) strokes on computed tomography angiography imaging and directly alert on-call stroke specialists about potentially treatable patients in a standalone or multi-hospital network.