US FDA device center's new Patient Engagement Advisory Committee held its second meeting on Nov. 15, focusing on the potential for social media and other patient-generated information to be a source of post-market medical device data.

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, says "a big payout" is a strong carrot for someone to file a whistleblower complaint against a device-maker. Check out what Weinman says is another top motivator here.

Regulators say they have found a correlation between patients given pain medication not approved for their specific implantable drug pumps and a higher number of adverse events.

With a high level of uncertainty still surrounding Brexit negotiations,  UK-based notified body BSI can now offer its clients a more certain future by migrating their certificates to BSI Netherlands if they wish.

The manufacturer of VascuLab devices used in vascular pathology was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by US FDA this week.

A new draft guideline issued by Health Canada represents the first phase of a 3D-printing policy in Canada.

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

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.

Matteo Lai, CEO of a company that makes the first US FDA-cleared seizure-monitoring smart watch, says users don't care much about artificial intelligence or fancy technology. Rather, they simply want the device to be easy to use and to do its job. See what Lai said about it here.

Abbott Laboratories pointed to success in its electrophysiology device business last quarter, driven by multiple products including the Confirm Rx insertable cardiac arrhythmia monitor, which the firm says is the thinnest in class, and is smartphone-compatible for more direct patient engagement. See what Abbott VP Ari Fischer says about it here.

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>

Startups at the convergence of technology and biomedical innovations showcased compelling innovations at this week's Exponential Medicine conference in San Diego. This article offers a roundup of new devices targeting a wide range of applications from neurology, cardiology, chronic diseases and wellness.

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.

Reported sales and earnings from the publicly traded cardiovascular device companies show strong performance across the sector, spurred by new approvals and clinical trials, in the quarter that ended Sept. 30. Here's a recap of results from the cardio device companies that have reported so far, including Abbott, Abiomed, and Reva.

A US federal working group focusing on tick-borne diseases is recommending more funds from Congress for Lyme disease diagnostic test development. As the number of cases increase, current diagnostics result in too many false positives and negatives, and there is essentially no test to show an infected individual has been cured, the group says.

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.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Two devices to help surgeons performing thyroid surgery made the list, as did several devices in the diabetes space.

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.