Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

Oct 2021: What's new in the world of (digital) diagnostics?

Policy and Regulatory

  1. Government set to announce extra £2.1bn for NHS IT

    Part of the funding would be invested in diagnostic tools and digital solutions to free up NHS staff to spend even more time with patients.

  2. NHSX announces projects are to receive share of £6.5m as part of Adoption Fund

    The projects range from nitiatives to support digital inclusion; gastroenterology pathways; musculoskeletal pathways; perioperative pathways; as well as cardiology and cardiac surgery networks.

  3. France unveils budget breakdown of its 650 million euro digital health acceleration strategy

    168 million euros will be earmarked for evaluation and experimentation of digital health technologies whilst 68 million euros will be set aside for training current and future health professionals on digital health technology.

  4. BfArM calls on DiGA manufacturers to take advantage of advisory services

    22 out of 100 applications made it through to Germany’s digital health applications directory for reimbursements. Many applicants realised halfway through the process that they did not fit the criteria and German health authorities (BfArM) is urging potential applicants to have an initial discussion (i.e. advisory services) to mitigate disappointment.

  5. FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

    Quanterix received the breakthrough designation for the Alzheimer's test. The status covers a blood test designed to measure the concentration of phospho-Tau 181 using the Quanterix HD-X immunoassay system.Nonagen Bioscience also received breakthrough device designation for its Oncuria non-invasive bladder cancer test.

  6. Proposed new timelines for the EU In-vitro Diagnostics Regulations

    The European Commission's proposal offers a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.

Companies

  1. PathAI and Roche team up to push adoption of digital pathology tech

    The strategic partnership will allow PathAI to develop and distribute its AI pathology tech through Roche’s uPath enterprise software, a workflow platform for labs.

  2. Guardant may acquire Neogenomics, but investors make disapproval known

    Guardant’s share price dropped about 20% on the news, closing at $107.51, a clear indication that investors were not happy about the rumored deal.

  3. Twin Health raises $140m for “digital twin” diabetes reversal app

    The idea is that analysis of the digital twin allows the health of the user to be continuously monitored, and advice delivered to the user on nutrition, sleep, activity and breathing via an app.

  4. Dexcom’s G7 CGM Is Almost Here

    The highly anticipated G7 continuous glucose monitoring (CGM) system could be available in Europe in the fourth quarter of 2021.

  5. Bayer, One Drop release digital health program for heart disease

    After striking a partnership last year, One Drop and Bayer are releasing their first digital health program for lowering the risk of heart disease. To start, One Drop plans to offer it to employers through its multi-condition program, but also plans to offer it to consumers through its app this year.