Clinical Trials Medtech - March 21, 2018
New clinical data from Bonesupport
Three papers based on the successful use of CERAMENT G to treat bone infections were presented at the British Limb Reconstruction Society (BLRS) Meeting 2018, which took place from the 15-16th March in Southampton, reports the company. One of the papers, entitled ‘The choice of local antibiotic carrier significantly affects outcome in treatment of chronic bone […]
Clinical Trials Medtech - January 9, 2018
Acarix initiates multi-center trial
The company has initiated a multi-center trial of its CADScor System for non-invasive, non-radiation acoustic detection of Coronary Artery Disease. The results from the study are expected to be available early 2020. Acarix believes the device has the potential to both improve triaging of patients and reduce the need for costly further invasive diagnostic investigations. […]
Clinical Trials Medtech - January 8, 2018
Nexstim enrols last patient in supplementary Phase III trial
The company has successfully completed enrolment in its supplementary Phase III clinical trial, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL), evaluating the use of Nexstim’s NBT system in upper extremity motor rehabilitation following stroke. The supplemental trial is being conducted at five clinical centres in the US and has […]
Clinical Trials Medtech - December 14, 2017
Bonesupport recruits 136 patients into their CERTiFy study
CERTiFY is a prospective, randomized, controlled clinical study designed to compare the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fracture-associated bone defectsusing either CERAMENT|BONE VOID FILLER (CERAMENT BVF) or autologous bone grafting (autograft). Autograft is the current gold standard for bone graft procedure for the management of […]
Clinical Trials Medtech - May 22, 2017
First patient enrolled in Bonesupport trial
BONESUPPORT announces that the first patient has been enrolled by Dr Ravi Karia at the University of Texas Health Science Center at San Antonio into the company’s pivotal Investigational Device Exemption trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (the FORTIFY trial: ClinicalTrials.gov […]
Clinical Trials Medtech - May 7, 2017
New medtech legislation comes into force on May 25th
On May 5th the European Commission published two new medtech regulations, the in vitro diagnostic medical device regulation (IVDR) and the medical device regulation (MDR). The regulations will come into force on Thursday May 5th 2017. MDR will replace the former regulations 90/385/EEG and 93/42/EEG and IVDR will replace the former regulation 98/79/EG. Now begins […]
