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Medtech Insight

2 Deaths Linked To Missing IFU For Cardinal Health Scalpel Used For Newborns

By Shawn M. Schmitt 20 Aug 2021

The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.

Medtech Insight

Countdown To 2022 EUEA System As Russia Increases Post-Market Medtech Controls

By Ashley Yeo 13 Aug 2021

There are just 4.5 months left until the new harmonized Eurasian Economic Union medtech system becomes mandatory, signifying major changes in regional market access. EAEU member Russia is meanwhile strengthening its post-market medtech controls.

Medtech Insight

EU Prioritizes Risk Management And Quality System Standards Now Legal Basis In Place

By Amanda Maxwell 13 Aug 2021

Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.

Medtech Insight

FDA Widens Scope In Considering Evidence For Off-Label Use

By Brian Bossetta 03 Aug 2021

After much wrangling, the US agency finally clarified its position on what evidence can determine "intended use" of a product – and industry is not happy.

Medtech Insight

Market Intel: Expanding Applications And Improved Offerings To Drive Robotically Assisted Surgery Market

By Barnaby Pickering 03 Aug 2021

The global market for robotically assisted surgical devices will reach $11.5bn by 2025 as system improvements drive sales.

Medtech Insight

Carrot’s Pivot Breath Sensor Helps Motivate Smokers To Quit

By Reed Miller 13 Jul 2021

Based on the results of a study with 234 smokers, the FDA cleared an updated indication for Carrot’s Pivot breath sensor, an over-the-counter carbon monoxide sensor that helps motivate people to stop smoking.

Medtech Insight

New Guidance On Registration Rules For Importers Into The EU

By Amanda Maxwell 13 Jul 2021

EU rapidly revises new guidance document on registration requirements under the new MDR and IVDR to address question of when importers need to register in Eudamed medical device database.

Medtech Insight

Onward Secures FDA Breakthrough Designation To Improve Movement, Quality Of Life After Spinal Cord Injuries

By Marion Webb 22 Jun 2021

Onward has been granted three FDA breakthrough designations for ARC Therapy, a spinal cord stimulation therapy that aims to restore movement and improve quality of life of people with spinal cord injuries.

Medtech Insight

US Treasury: Devices To Fight COVID-19 Can Be Shipped To Sanctioned Nations Under New Directive

By Elizabeth Orr 22 Jun 2021

The exemptions allow for face masks, diagnostics and oxygen tanks, among others, to be shipped to Iran, Syria and Venezuela without specific permission.

Medtech Insight

New Treatment From Shockwave Medical For Clogged Arteries Gets CMS Pass-Through Payment

By Brian Bossetta 18 Jun 2021

Starting 1 July, Medicare beneficiaries with a certain type of cardiovascular disease will be able to receive an innovative treatment covered under their government plans.

Medtech Insight

Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR

By Amanda Maxwell 16 Jun 2021

With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

Medtech Insight

StrataGraft Topical Burn Treatment Gets US FDA Approval

By Elizabeth Orr 15 Jun 2021

The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.

Medtech Insight

Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users

By Amanda Maxwell 08 Jun 2021

Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.

Medtech Insight

Pre-MDR Predictions and What You Can Expect

07 Jun 2021

Updates to the EU Medical Devices Regulation are just weeks away from becoming a reality for manufacturers and suppliers. Medtech Insight delivers expert insights into the latest developments and what they could mean for your business.

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