After getting its 510(k) application rejected by the U.S. FDA for its AI-enabled Salix coronary anatomy software (SCA), Australian medical technology company, Artrya Ltd. scored regulatory approvals in the UK and in the EU.
The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds.
Surgical teams from the Department of Oncology at Toulouse University Hospital and the Cancer University Institute of Toulouse Oncopole have achieved a total reconstruction of a patient’s nose using a 3D-printed synthetic graft previously implanted in her forearm to pre-vascularize it.
The government in France has just launched the Health Innovation Agency. This new government agency aims to improve identification of future health technology and better anticipate the impact of innovation in France.
The U.K. National Institute for Health and Care Excellence (NICE) has opened a consultation on the use of five digital health products that can be used to help children and adolescents better manage anxiety or low mood.
Diagnostic Medical Systems Group SA (DMD) is selling its entire stake in the share capital of Hybrigenics SAS, a biotech company listed on the Paris Euronext Stock Exchange since 2007. This sale of 116,911,328 shares, representing 43.41% of Gard, France-based Hybrigenics’ share capital, will allow DMS Group to refocus on its core imaging business. “We will strengthen our free cash in order to ramp the launch of new technology in medical imaging,” Samuel Sancerni, CEO of Diagnostic Medical Systems, told BioWorld.
Researchers from the Structural Biology Center at Montpellier University in France have devised a DNA-based nano robot capable of exploring cells in the human body. This 50-nanometer robot has been designed to study up close the mechanical forces applied at microscopic levels on cells, which trigger biological signals involved in the development of pathologies such as cancer and neurodegenerative disorders.
Lattice Medical SAS reported the first successful breast reconstruction using Mattisse technology, a totally resorbable, 3D-printed implant which naturally regenerates fatty tissue. The procedure was performed at the Institute of Clinical Oncology in Tbilisi, Georgia. It was the work of cancer specialist Gia Nemsadze and his team. This was an immediate breast reconstruction for a 62-year-old patient with breast cancer. The surgical procedure lasted one and a half hours, allowing the mastectomy to be completed, immediately followed by the breast reconstruction.
A number of devices, imaging systems and in vitro diagnostics have become available for colorectal cancer (CRC) screening over the years, several of which are of very recent origin, a marker of sustained interest and investment in these products. The problem for industry is that a new randomized trial conducted in Europe suggests that the impact of CRC screening on all-cause mortality is zero compared to no screening, a finding that could prompt policymakers to revisit their stances on screening to the detriment of sales of these devices and diagnostics.
A new ultrasound-based technique has been developed to overcome the shortcomings of conventional X-ray mammography in screening younger women whose breast density is high.
