Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.

With FDA clearance of its Endoscreener that uses artificial intelligence (AI) to detect polyps during coloscopy procedures, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools.

Royal Philips NV launched a new solution, Ambient Experience with Flexvision display, for use in interventional rooms. The system, intended to reduce patient anxiety in the run up to a procedure, is commercially available globally, including in the North American region. According to the company, Ambient Experience connects to its Azurion image-guided therapy system and is designed to enable interventional team members to adapt the room’s ambient lighting and sound to enhance the overall feeling of calm.

Carthera SA reported results from a pilot clinical trial to evaluate the safety and efficacy of its Sonocloud technology in patients with mild Alzheimer’s disease (AD). The results, published in Alzheimer’s Research and Therapy, show early promise of the treatment in reducing the amyloid load of AD and potentially other neurological conditions as well as to stimulate neurogenesis and improve cognitive performance.

T2 Biosystems Inc. is accelerating development of its T2biothreat and T2resistance panels, direct-from-blood panels that detect the six pathogens most likely to be weaponized and 13 common antibiotic resistance genes, respectively. A $4.4 million Biomedical Advanced Research and Development Authority (BARDA) cost-sharing contract will be used to advance clinical trials for the tests. The total potential funding from BARDA under the contract is $69 million.

With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.