The latest guidance from the UK devices regulator fills in some of the information gaps for companies addressing the Northern Ireland and EU27 markets after this year, seen through the lens of Brexit.

The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.

The US Medicare agency coupled its proposed coverage memo on colorectal cancer screens based on blood-based biomarker tests with a note that the Epi proColon assay does not meet its criteria.

No device-related warning letters were released by the US FDA the week of 20 October.

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

During her confirmation hearings, Judge Amy Coney Barrett denied it’s her goal to end all Affordable Care Act coverage, but some senators and legal experts disagree. And if the ACA is struck down, coverage for chronic disease treated with medical devices – including cancer, heart disease and diabetes – could fall by the wayside.

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

The European Commission is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.

The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

The COVID-19 pandemic continues to drive innovation in robotics to provide care and comfort at a safe distance. 

Johnson & Johnson's Ashley McEvoy explains how the global medtech business should change, seen through the lens of the coronavirus pandemic.

The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

COVID-19 business volatility continues to impact the medtech industry, but Royal Philips is targeting modest comparable sales growth for 2020 after posting quarterly growth of 10%.

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

Results from two trials confirm patients at high risk of bleeding treated with Abbott’s Xience stent can be safely treated with short regimens of dual antiplatelet therapy.

The SCOPE II results could have helped support a PMA for Acurate neo2 in 2021, but the trial missed its primary endpoint, and the REPRISE IV trial of Boston Scientific's Lotus Edge TAVR system has been delayed by COVID-19.

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

The SMART trial will compare Medtronic’s Evolut TAVR systems to Edward’s Sapien 3 devices. Evolut EXPAND TAVR I will evaluate Evolut in patients with symptomatic moderate aortic stenosis or asymptomatic severe disease.

Following the US Medicare agency’s recent proposed rule to give immediate national coverage for breakthrough devices, Simos Kedikoglou spoke with Medtech Insight about what it could mean for companies like his.