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Featured Stories

UK Medtechs Determined To Exploit Digital Health Opportunity Born From The Pandemic

COVID-19 has forced a rethink in how care should be delivered. Healthcomms Consulting partner Dan Jones says it is an opportunity that must not be squandered.

United Kingdom Policy Medical Device

Economic Operators: New Responsibilities & How To Manage Them

The new EU MDR rules for economic operators are complex and burdensome for those not used to them. Chad Reynolds of RMQ+ outlines practical strategies for managing economic operators efficiently, and with a view to long-term compliance.

Europe EU Medical Device

Biden COVID-19 Plan Would Grow Domestic Manufacturing Base

The proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.

Manufacturing Coronavirus COVID-19 Policy

FDA Suspends Premarket Notification Requirement For 7 Devices; 84 More Under Consideration

The US HHS and the FDA on 14 January published a notice that permanently waives premarket notification requirements for seven types of gloves that were given temporary waiver during the pandemic. Regulators are looking to expand the waiver to 84 other products.

Regulation Approvals Compliance

Commission Expert Panel Appointments Give Green Light To High-Risk Device Certification

The appointment of the European Commission expert panels opens the door to full conformity assessment for innovative high-risk devices. But the uneven distribution of experts will mean queues are expected for some type of work. for their work at some than others.

Europe EU Medical Device

Device Week, 14 January 2021 – FDA Commissioner News; Spotlight On COVID-19 Enforcement Issues

On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.

FDA Leadership Enforcement

QUOTED. 15 January 2021. Kevin Conroy.

Exact Sciences CEO Kevin Conroy discussed the company’s future at the annual J.P. Morgan Healthcare Conference

Quoted Financing Launches

Device Week Podcast



Discussed in this episode:

Study Results Support Zimmer Biomet’s Knee Surgery Remote Care System

Zimmer Biomet’s mymobility remote care management platform is part of the company’s overall effort to work more directly with patients, especially dur...

Clinical Trials Sales & Earnings

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Latest from PR Newswire


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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

US FDA Panel To Take Up Lutonix DCB Catheter For Lower-Leg Use Next Month

If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.

Advisory Committees Regulation Cardiology

Woodcock To Be Acting US FDA Commissioner, Leaving Agency in Stable, Capable Hands

The agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give the incoming Biden team cushion to confirm a permanent leader, of whom a top contender is former senior FDA staffer Joshua Sharfstein.

Leadership FDA Elections

Latest From Policy & Regulation

India Permits Sale Of Some Devices Beyond Licensing Deadline

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.

Regulation India

UK Device Safety To Be Enhanced By Patient Safety Commissioner

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.

United Kingdom Safety

Attorneys Expect COVID-19 ‘Enforcement Press’ Centered On PREP Act, Diagnostics

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.

Enforcement FDA

Australia Considers Redefining Central Circulatory System To Align With EU

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. 

Australia Regulation

Industry Praises CMS Final MCIT Reimbursement Rule; Urges Biden Team To Implement It

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.

Policy Medicare

FDA Commissioner Hahn To Seek Public Health Leadership Post To Work On COVID-19 Issues Next

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.

Policy Leadership

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Commission Allows Virtual MDR and IVDR Audits – Under Strict Conditions

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.

EU Europe

FDA Announces Recall Of Boston Scientific’s Lotus Edge TAVR System

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.

Recalls Safety

Top 20 EU Regulatory Stories Of 2020: Nightmare Year With Brexit, MDR Implementation … And COVID-19

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?

Europe EU

OUTLOOK 2021 IS LIVE

Access In Vivo’s annual showcase of special features and industry league tables, including Scrip 100

VIEW 2021 RANKINGS

Commercial Explore this Topic

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Cantel Medical Snapped Up By Steris For $3.6Bn

The deal combines two of the largest providers of sterilization and infection-prevention products to create a $4bn-plus-revenue business.

M & A Commercial Companies

Latest From Commercial

JPM 2021: Conformis Announces ACS Knee For 2H 2021, Integra Weathers Pandemic

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.

Orthopedics Financing

JPM 2021: Intuitive Surgical, Accelerate Diagnostics, Siemens Healthineers, Exact Sciences, Renalytix

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.

Financing Launches

JPM 2021: Boston Scientific, Abbott, Dexcom, Insulet, Silk Road Medical

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.

Financing Launches

JPM 2021: Medtronic, Biogen, Edwards LifeSciences, Guardant Health, Illumina

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.

Coronavirus COVID-19 Digital Health

JPM 2021: EY Says Pandemic Leaves Medtech With $500Bn In M&A Firepower

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.

M & A Financing

Outlook 2021: Medtechs Must Look To Late 2021 And 2022 For A Return To Normal Times

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.

Commercial Medical Device

Clinical R&D Explore this Topic

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Medtronic’s ICM Proves Cost-Effective In Preventing Recurrent Stroke

A new study shows implantable cardiac monitors are a cost-effective tool for preventing recurrent strokes following a stroke suspected to be caused by atrial fibrillation.

Clinical Trials Cost Effectiveness Digital Health

Latest From Research & Development

JPM 2021: Conformis Announces ACS Knee For 2H 2021, Integra Weathers Pandemic

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.

Orthopedics Financing

JPM 2021: Intuitive Surgical, Accelerate Diagnostics, Siemens Healthineers, Exact Sciences, Renalytix

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.

Financing Launches

JPM 2021: Boston Scientific, Abbott, Dexcom, Insulet, Silk Road Medical

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.

Financing Launches

JPM 2021: Medtronic, Biogen, Edwards LifeSciences, Guardant Health, Illumina

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.

Coronavirus COVID-19 Digital Health

Device Week, 7 January 2021 – A Closer Look At Acquisitions By Hologic And Stryker

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.

Device Week M & A

Hologic Continues Spending Spree With $230M Tuck-In Acquisition Of Biotheranostics

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

M & A Cancer
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