Latest from Natasha Barrow
Evidence-based testing in real clinical settings and diagnostics tailored to community needs are crucial adoption success factors for new IVDs, Michael Wright, joint medical director at Newcastle Hospitals NHS Foundation Trust, told Medtech Insight at a regional UK meeting.
Excitement surrounds Multi Cancer Early Detection testing for diagnosing hard-to-detect cancers early and improving patient outcomes. But without full randomized trials – only accuracy studies – physicians lack enough evidence to use them confidently, said physician and researcher Daniel Jonas.
Resitu Medical has received FDA 510(k) authorization for the RESL09 breast cancer biopsy device. This handheld minimally invasive device excises tissue samples with diameters up to 9 mm and will first reach market in the US. The company plans to expand the tool’s clinical claims and core size range.
The Nancy Gardner Sewell MCED Act has advanced in the US House, potentially allowing Medicare coverage for multi-cancer early detection tests. Exact Sciences is targeting FDA approval for its MCED test Cancerguard, launched in the US earlier this month.
Sava Technologies has developed a CGM that uses microneedles to accurately measure glucose levels for up to 10 days without finger-prick calibration. The company raised £14.2m in Series A funding to establish in-house manufacturing for faster production.
The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.
