German Federal Joint Committee (G-BA) has requested manufacturers of extracorporeal shock wave therapy devices for heel pain to submit notifications about their technologies

14

Jun 2017

Recently the Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation extracorporeal shock wave therapy in patients with heel pain. It was concluded that this method is superior to placebo, ultrasound and iontophoresis (see the summary of assessment here).

On 31st of May, the Federal Joint Committee (G-BA) requested manufacturers for notification of their devices for extracorporeal shock wave therapy before final decision will be given.

Relevant documents should be submitted by manufacturers for this purpose till 29th of June in electronic form by e-mail:

  • The medical device certificate or the certificate of conformity of the medicinal product for placing on the market in Germany
  • The technical instruction for use

Additionally, submission should include following statements:

  • The description of device
  • The description of the integration of device into method of treatment
  • The purpose for which device has been placed on the market

See full request in German here.

Subscribe to our biweekly newsletter not to miss important reimbursement information.

The latest related news

22

Mar 2022

On February 17, 2022, the Federal Joint Committee (G-BA) has decided to include the method of matrix-associated autologous chondrocyte implantation (M-ACI) on the knee joint in the case of symptomatic cartilage damage in the lists of reimbursed procedures in the hospital and ambulatory settings.

Read more

09

Mar 2022

On February 16, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) has published the decisions which recommended the transfer to standard care for three completed projects. The projects relate to the prevention of antibiotic resistance, improvement of healthcare in socially disadvantaged areas, and misuse of control colonoscopies in Germany.

Read more

03

Mar 2022

In February 2022, two more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, thirty health apps are now available at the DiGA Directory.

Read more

07

Feb 2022

On January 20, 2022, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for the use of a stent retriever (pRELAX by femtos) to treat vasospasm of cerebral arteries after subarachnoid hemorrhage.

Read more

28

Jan 2022

On December 26, 2021, the new health app was introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, 28 health apps are now available at the DiGA Directory.

Read more