Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

Jan 2022: What’s New In The World Of Diagnostics?

Policy and Regulatory

  1. NICE to approve changes for NHS technology evaluation

    Amongst the changes, NICE will expand on and improve how it considers real-world evidence from the lived experiences of patients. NHS will also provide greater clarity around the circumstances in which NICE committees can make a managed access recommendation.

  2. Reliable DiGA - remuneration for doctors required

    There is still not a single provisionally listed DiGA with a specific remuneration for physician services, the Central Association for Digital Health Care warns.

  3. Telemonitoring for heart failure can start

    German medical practices can now provide telemedical care to patients with advanced cardiac insufficiency, which is reimbursed in the EBM.

Initiatives and companies

  1. Guardant Enrolls Ist Patient in SHIELD Lung Study

    The Redwood City, CA-based company has enrolled the first patient in the Screening for HIgh-frEquency maLignant Disease (SHIELD) LUNG study, a nearly 10,000-patient prospective, registrational trial.

  2. Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests

    The study, which Exact Sciences designed to mimic its ongoing pivotal trial, found Cologuard 2.0 has a lower false positive rate than the current product and is better at detecting precancerous lesions

  3. Freenome gets $290M from Roche as it preps blood-based cancer test’s next steps

    From a routine blood draw, Freenome’s diagnostics technology finds biological and genetic signs of cancer before they can be detected by currently available testing methods.

  4. KardiaMobile recommended by NICE for detecting abnormal heart activity

    A smartphone based electrocardiogram (ECG) has been recommended by the National Institute for Health and Care Excellence (NICE) as an option for detecting atrial fibrillation within ambulatory settings in the NHS

  5. Quidel's Diagnostic Success Pays Off with Major M&A

    The San Diego, CA-based company said it has signed an agreement to acquire Ortho Clinical Diagnostics Holdings for $6 billion.

  6. Abbott CEO Ford showcases new ‘biowearable’ line at CES

    The new wearable line is called Lingo, a nod to learning how to understand the body’s language. It is being designed to track key biomarkers in the body – namely glucose, ketones, lactate, and eventually alcohol – to help people better understand their general health and take action.

  7. Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing

    The COVID-19 pandemic has enabled consumers to perform rapid self-tests in the comfort of their homes, a convenient option that test makers are hoping to cash in on with over-the-counter and direct-to-consumer testing for other diseases beyond the coronavirus

  8. Roche debuts smart glucose monitor for hospital use

    The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen that is used for displaying patient information and data, as well as analysing and sharing clinical results.

  9. IBM Bids Farewell to Watson Health Assets

    IBM is reportedly it is selling its healthcare data and analytics assets, currently part of the Watson Health business, to an investment firm.The sale price is reportedly more than $1 billion, although the companies are not officially disclosing the financial terms.

  10. Diabetes and high blood pressure: contract for better care in Rhineland-Pfalz

    The Rhineland-Pfalz Association of Statutory Health Insurance Physicians ( KV ) and the AOK Rhineland-Pfalz/Saarland have concluded a new contract for the early diagnosis and treatment of concomitant diseases associated with diabetes and high blood pressure.

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