Novartis, Foundation Medicine collaborate on companion diagnostics

International – Novartis, Foundation Medicine collaborate on companion diagnostics

A company focused on next-generation sequencing-based diagnostics is partnering with a large Swiss drugmaker. Foundation Medicine, based in Cambridge, Massachusetts, said Wednesday that it had formed a...
Valeritas' wearable insulin delivery device debuts in Italy

Italy – Valeritas launches wearable insulin delivery device in Italy

Valeritas (NSDQ:VLRX) said today that its wearable insulin delivery device has launched in Italy. The Bridgewater, N.J.-based company inked an exclusive distribution deal with Movi SpA...
MDR and IVDR Implementation: Update from the European Commission

Europe – EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes

As we move towards the E.U.’s Medical Device Regulations (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746) — MDR and IVDR, respectively —...
25 Medtech Startups You Need to Know

International – 25 Medtech Startups You Need to Know

There are about 25 early-stage companies that could possibly change healthcare and cause us to rethink the we go about treating illnesses. These 25 companies are derived...
7 electronic design problems that boost medical device costs

USA – 7 electronic design problems that boost medical device costs

Products that are challenging to build typically result in longer lead times, lower margins, and possibly lower quality compared with products that are designed...
Your device design looks great. Now how do you get reimbursement?

USA – Your device design looks great. Now how do you get reimbursement?

Continued increases in the cost of healthcare are driving stakeholder interest in reimbursement. Investors want to know up front whether there will be coverage,...
FDA to beef up cell and gene therapy staff

USA – FDA Tweaks List of Recognized Consensus Standards for Devices

A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday...
Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3

Europe – European Commission Offers Guidance on UDIs

Building off guidance released in March, the European Commission this month unveiled five new guidance documents on the use of unique device identifiers (UDIs). The...
EU Releases Working Plan to Implement MDR/IVDR

Europe – EU Releases Working Plan to Implement MDR/IVDR

The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations...
TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

USA – Cybersecurity: FDA Spells Out Updated Premarket Policies

With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on...

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