Existing importers and manufacturers of certain medical devices can continue marketing their products for six months or until the Indian medtech regulator makes a final decision on their pending licensing applications.

Certain Cumberlege Review recommendations are making their way into draft UK legislation as the government presses ahead in shaping the UK’s post-Brexit devices regulatory system.

Three attorneys got out their crystal balls to forecast what device industry sectors may come in for enforcement scrutiny related to the COVID-19 pandemic.

Differences between how Australia and the EU define “central circulatory system” has resulted in different risk classification levels being assigned to some devices in the two jurisdictions. 

The US Medicare agency issued on 12 January its final MCIT rule allowing instant reimbursement for FDA breakthrough devices – unless the incoming Biden administration blocks it.

Outgoing US FDA chief Stephen Hahn has signaled that he’ll seek a posting in public health, where he can increase equity and help in the fight against COVID-19.

Notified bodies may temporarily deviate, where fully justified, from the MDR and IVDR rules for notified body audits of manufacturers’ QMS to take place on site. Vital audits can now go ahead.

The US agency announced on 11 January a recall of the Lotus Edge transcatheter aortic valve replacement (TAVR) system – a device that Boston Scientific stopped making and voluntarily recalled two months ago.

Not only might each day feel like Groundhog Day now – with COVID-19 limiting everyone’s activities. But early 2021 puts the EU medtech sector in a similar place to early 2020. So what has changed?

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the final day of the meeting.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the third day of the meeting.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the second day of the meeting.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the first day of the meeting.

EY’s M&A Firepower report predicts very active M&A activity for medtechs in 2021, driven by diagnostics and digital health, but with some headwinds remaining.

Delivering innovation is still the driving force for medtechs intent on growing in the market, regardless of COVID-19, the disruptive effects of which have intensified with the appearance of new variants, says Jefferies Healthcare equity analyst Raj Denhoy.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the final day of the meeting.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the third day of the meeting.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the second day of the meeting.

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the first day of the meeting.

In this week’s podcast, Medtech Insight's deputy editor Reed Miller discusses Stryker’s buy-out of OrthoSensor and the rising importance of biosensor technology in orthopedics. Medtech Insight's managing editor Marion Webb discusses Hologic’s buy-outs of Somatex and BioTheranostics and planned coverage for next week’s J.P. Morgan Healthcare Conference, Digital Medicine & Medtech Showcase, and NANS meeting.

Hologic’s recent buy-outs put it in a strengthened growth and competitive position beyond COVID.