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.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market.
In a development that is a potential boon for wearables and other sectors of the digital health industry, the U.K.’s NICE has petitioned the National Health Service (NHS) to expand its coverage of devices that monitor patients with Parkinson’s disease. That data would be used by NICE to inform a health technology assessment that might ultimately boost sales of these devices if the data suggest a strong benefit to patients and to the U.K. health care budget.
Fujifilm Healthcare Europe received the European CE mark for its next-generation therapeutic linear array ultrasound endoscope, the EG-740UT, designed for complex diagnostic and therapeutic endoscopic ultrasound procedures.
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
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