Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.

On this week's podcast, David Filmore and Ferdous Al-Faruque discuss the results of this week's midterm elections in the US and what it could mean for the medtech sector.

Recently announced US National Evaluation System for health Technology "test cases" will be evaluated for up to a year by the NEST Coordinating Center after which collaborating device-makers may be in a better position to use real-world evidence to support new pre-market device submissions. The test cases will be measured, in part, based on their ability to identify brand-specific devices in the NEST Network Collaborators’ real-world datasets.

The balance of power will be shifting in Washington, DC, following the Nov. 6 US midterm elections, but that probably will not mean major changes for medtech policies. Here are some key takeaways from the election for device and diagnostics companies.

With most of the Nov. 6 election tally completed, it’s clear there will be many new faces for the device industry to engage with in the halls of Congress, but the sector still appears to have a significant group of supporters on Capitol Hill. Also, several medtech-relevant measures were on the ballot.

The clinical laboratory industry praised the US Centers for Medicare and Medicaid Services for making changes in its final Clinical Laboratory Fee Schedule rule to allow more data from hospital outreach labs to be considered in setting laboratory test pay rates. But lab advocates are still pursuing a lawsuit and pushing for legislative reforms.

FDA’s latest update to Unique Device Identification compliance deadlines says the agency won’t enforce direct marking UDI rules for some existing devices if the UDI can be determined in other ways.

The chair of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is warning of "instability" in industry if the International Organization for Standardization (ISO) Technical Management Board has its way and makes changes now to international quality systems standard ISO 13485.

Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to "gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming," TC210 delegate Kim Trautman says. The survey closes Nov. 9.

Reported sales and earnings from the publicly traded orthopedics device companies showed mix results during the third quarter of 2018. NuVasive was the star performer in the group while, on the other end of the spectrum, Stryker continued to show strong growth across most its businesses, while Johnson & Johnson's orthopedic device revenue was near flat.</p>

Medtech Insight highlights Q3 2018 results from some of the leading IVD players. In this edition, we spotlight some of the big companies including Roche Diagnostics, Thermo Fisher Scientific, bioMérieux, and Becton Dickinson.

RedMed Inc. is continuing to invest aggressively in its "software-as-a-service" offerings with the addition of MatrixCare, a provider of long-term post-acute care software. See what MatrixCare CEO John Damgaard said about it here.

Stryker and plaintiff attorneys are hashing out an agreement to settle thousands of lawsuits brought by patients who say they were injured by the device-maker's hip implants.

This week, a new corporate development senior VP arrives at clinical and research diagnostics firm Abcam, a VP opts out of business development post at Danaher to strategize for Agilent Tech, and a supply chain exec departs J&J.

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, between Oct. 29 and Nov. 4, 2018.  

When ALung Technologies was selected in 2015 by US FDA to participate in the agency's Expedited Access Pathway program for its novel Hemolung device, the firm wasn't necessarily sure what it was getting itself into. See what ALung CEO Pete DeComo said about the pathway – now called the Breakthrough Devices Program – here.

With 25 device and diagnostics start-ups in its portfolio, the Pittsburgh Life Sciences Greenhouse aims to establish life-sciences companies in Western Pennsylvania by leveraging the area's top schools and best-in-class medical facilities. See what the Greenhouse's Harold Safferstein said about it here.

In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.

ALung CEO Pete DeComo says the start-up's novel Hemolung device might never have seen the light of day if it weren't for the support of the company's local community and, in particular, investment firm Pittsburgh Life Sciences Greenhouse. And ALung isn't the only Pittsburgh medtech firm the Greenhouse is aiding – there are currently 25 device and diagnostics start-ups in its portfolio.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among them, a portable neuromodulation device is approved in Canada for traumatic brain injury.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the additions, Abbott's HeartMate 3 left ventricular assist device gained "destination therapy" approval from US FDA, meaning its now vetted for use in patients who are not eligible for a heart transplant.