Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

April 2021: What’s new in the world of (digital) diagnostics?

New Products, Partnerships, Discoveries

1.       Illumina ‘Pushes Back’ on European Commission’s ‘PushBack’ of Grail Acquisition

Illumina has filed an action to annul the European Commission’s decision to have the Grail acquisition reviewed.

 2.       Hologic pens $795M Mobidiag buyout to expand in acute care testing

With the deal Hologic acquire two automated PCR instruments used in the diagnosis of gastrointestinal and respiratory infections and management of antimicrobial resistance.

3.       Vitamin D deficiency: US panel continues to advise against screening

The USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults.

4.       Device Using AI to Detect Colon Cancer Wins FDA Authorization

GI Genius, developed by Cosmo Artificial Intelligence, is the first device that uses artificial intelligence based on machine learning for this purpose.

5.       AstraZeneca lands first big partner for digital health platform

The company came to an agreement with Mass General to use its platform for heart failure and asthma management.

6.       Kaiku Health joins forces with Novartis for melanoma monitoring and support

The companies will zero in on creating a remote monitoring and support network for patients receiving a specific drug combination, known as BRAF and MEK inhibitors.

7.       Roche's mySugr app to integrate with Novo Nordisk's smart insulin pens

The collaboration/ integration aims at boosting data collection and sharing more insights with healthcare providers in order to guide disease management.

8.       DTx company Pear inks slew of deals to integrate more digital biomarkers and a digital pill into platform

The company achieved collaboration deals with Empatica, etectRX, and a licensing deal with KeyWise.

 

Coverage, Policy and Regulatory

1.       Framework agreement on the compensation amounts of the DiGA presented

It remains open, whether and how provisions on maximum prices and thresholds will be included in the framework agreement.

2.       Medtronic inks value-based care pact with Spectrum Health

The focus is initially put on automating identification of readmission events in patients who use a Medtronic cardiac resynchronization therapy device.

3.       One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Manufacturers still face a lack of clarity, high costs, and manual processes in order to comply with the new regulation. These results come a few weeks before the new validity date.