The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for premarket approval. The agency says deficiencies in analytical methods for evaluating CM&S hampers its use in supporting regulatory submissions.
Medical device manufacturers often rely on computational modeling and simulation (CM&S) when designing new products. CM&S technology allows engineers and designers to conduct countless simulated experiments on virtual subjects.
During these experiments, numerous variables can be introduced into a programmed computation, then adjusted to observe various outcomes. These simulations...
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.
The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.
Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
