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News and blog posts

15
Jun 2020

Decisions about add-on reimbursement for medical devices in France in May 2020

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in May 2020 concern various types of devices, including cardiovascular devices (self-expanding intracranial stents, TAVI), CT navigation kit for CT-guided percutaneous interventions and medical aids. A total of 8 decisions were made.
08
Jun 2020

New procedure codes implemented by the Dutch Healthcare Authority in 2020

New codes for Prostatic Urethral Lift system, CT and MRI examination of the neck, fecal microbiota transplant, testicular sperm extraction, implantable rechargeable and a non-rechargeable pulse generator for deep brain stimulation, as well as PET-CT myocardial perfusion with volume, ejection fraction and flow measurements and molecular diagnostics, were implemented in 2020.
05
Jun 2020

New software supporting sleep testing device (Brizzy) now available on mHealthBelgium

On May 4, 2020, a new web platform called Brizzy entered the level 1 of the mHealthBelgium validation pyramid. Brizzy (class IIa) sleep testing device allows diagnosing respiratory sleep disorders efficiently and accurately and avoids the complexity and discomfort associated with traditional systems. The web platform allows for the analysis of the assessment of the collected data.
02
Jun 2020

Reimbursement application portal for digital health apps is live in Germany

The application portal for inclusion in the directory of digital health apps (DiGA) at the Federal Office for Drugs and Medical Devices (BfArM) has been online since May 27, 2020. The application, which can be submitted only electronically, is the first step for the respective health app to be reimbursed in the future as part of regular care.
29
May 2020

Regulatory registration procedure for COVID19 diagnosis medical devices maximally accelerated in Russia

As part of efforts to increase the effectiveness of measures to prevent the spread of coronavirus infection, the Ministry of Health of Russia informed suppliers, manufacturers and executive authorities that, subject to the rules for submitting documents for registration of medical devices intended for the diagnosis of coronavirus infection, their registration will be carried out as soon as possible deadlines.