Blog
RSS FeedPosted by Michael Wonder on 26 Mar 2021
FDA authorises marketing of device to improve gait in multiple sclerosis patients
26 March 2021 - Today, the U.S. FDA authorised marketing of a new device indicated for use as a short-term treatment ...
Posted by Michael Wonder on 26 Mar 2021
FDA approves first in the world device to treat patients with congenital heart disease
26 March 2021 - New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants two new breakthrough device designations for Natera’s Signatera MRD test
24 March 2021 - Natera today announced that the US FDA has granted two breakthrough device designations covering new intended ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants breakthrough device designation to Tempus’ atrial fibrillation ECG analysis platform, developed in collaboration with Geisinger
24 March 2021 - Tempus today announced that the U.S. FDA has granted the company breakthrough device designation for its ECG ...
Posted by Michael Wonder on 18 Mar 2021
Stimdia Medical receives FDA breakthrough device designation for the pdSTIM system designed to facilitate weaning patients from mechanical ventilation
18 March 2021 - Stimdia Medical today announced the company’s pdSTIM system has received breakthrough device designation from the U.S. FDA. ...
Posted by Michael Wonder on 17 Mar 2021
Sparta Biomedical receives FDA breakthrough device designation for SBM-01 biomimetic implant
17 March 2021 - Sparta Biomedical today announced that its SBM-01 biomimetic implant has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 17 Mar 2021
Leveraging real world evidence in regulatory submissions of medical devices
16 March 2021 - Among the many ways that the U.S. FDA protects and promotes the public health is by ensuring ...
Posted by Michael Wonder on 11 Mar 2021
Revolutionary option for medical device sterilisation approved by FDA
11 March 2021 - The United States FDA newly approved chlorine dioxide gas for contract sterilisation of medical devices. ...
Posted by Michael Wonder on 11 Mar 2021
Berlin Heals receives breakthrough device designation from FDA for its C-MIC heart failure device and initiates early feasibility study in the United States
11 March 2021 - Berlin Heals announced today that the US FDA has granted a breakthrough device designation for its ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants breakthrough device designation for Inivata’s RaDaR assay
9 March 2021 - Designation will help accelerate the regulatory path of RaDaR for use in detection of minimal residual ...
Posted by Michael Wonder on 10 Mar 2021
U.S. FDA accepts UVision360 submission for novel Luminelle DTx system biopsy sheath
9 March 2021 - UVision360 announces today that the U.S. FDA has accepted the Company's submission to expand the Luminelle DTx ...
Posted by Michael Wonder on 04 Mar 2021
FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
Posted by Michael Wonder on 04 Mar 2021
MedAlliance receives fourth FDA breakthrough device designation for sirolimus drug eluting balloon in treatment of de novo coronary lesions
4 March 2021 - MedAlliance has now been awarded breakthrough status for SELUTION SLR, its sustained limus release DEB catheter, in ...
Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...
Posted by Michael Wonder on 03 Mar 2021
Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine
2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...