MedTech Business - April 14, 2023
AlgoDx announces FDA acceptance of De Novo application
The US Food and Drug Administration has accepted for review the company’s De Novo application for NAVOYÒ Sepsis, a clinical decision support software intended to assist healthcare providers at intensive care units (ICU) with predicting sepsis in adult ICU patients. “We are proud to announce that our software NAVOYÒ has been accepted by the FDA […]
MedTech Business - March 15, 2023
EpiGuard approved by TGA in Australia
The EpiShuttle is approved by the Therapeutic Goods Administration (TGA) and is now fully available for use in the Australian market. “Even though The EpiShuttle has been with RAAF for some time now, we are happy to see that the safe isolation and transport system now fully available to the civil Australian market,” says Michael […]
MedTech Business - March 1, 2023
More personalized breast cancer screening
A new Norwegian clinical pilot will investigate how women can receive more personalized breast cancer screening. “This ‘one size fits all’ approach does not take into account the different breast cancer risks of individual women. A more personalised screening program might be beneficial for both women and society, both in terms of increased surveillance of […]
Financing - January 25, 2023
AI Medical Technology nets 10.8 million SEK
The startup company has completed a heavily oversubscribed fundraise. The new funds will be used initially to expand the company’s clinical trial program for its Dermalyser AI-driven support tool in Sweden and other key European markets, as well as finalize CE marking and commercialization, states the company. In addition, the company is starting to work towards […]
Financing - January 13, 2023
HVR Cardio closes a 11 million USD financing round
The Series B financing round of HVR Cardio was led by Finnish Innovestor Life Science Fund and Tesi. The Finnish cardiovascular device company HVR Cardio is developing a catheter-based solution CathHELIX, which makes it possible to repair the fault without the need for demanding open-heart surgery. The solution has already been granted Breakthrough Device Designation status by the […]
MedTech Business - November 8, 2022
AI Medical Technology receives ISO certification
AI Medical Technology announces its quality management system is now ISO 13485:2016 certified by BSI under the certificate number MD762240. This indicates that AI Medical Technology’s quality management system conforms to the recognized international standard for the design, manufacture and distribution of medical devices. The certification also demonstrates that AI Medical Technologies’ quality management system […]
