US FDA is proposing to amend its regulations to allow an institutional review board to waive or alter informed consent when a clinical investigation "poses no more than minimal risk" to human subjects and includes safeguards to protect their rights and safety. See what agency head Scott Gottlieb said about it here.

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.

The agency seeks input on the types of qualifying investigations that involve minimal risk. Providing informed consent waivers in these cases, as required by the 21st Century Cures Act, will help advance health-care innovations, FDA says.

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.

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

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.

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

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.

Mainstay Medical says it will move forward with a US PMA application for its ReActiv8 neuromodulation therapy for chronic back pain even though the ReActiv8 clinical trial failed to reach its primary endpoint.

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.

Promotions bring execs to the top spots at ostomy and wound-care specialist Coloplast AS, imaging solutions and ortho surgical care company EOS Imaging, and ophthalmics AI firm Notal Vision. Those and more recent medtech personnel moves.

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.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. CE marks for a Medtronic stent graft and Edwards Lifesciences' TAVR update anchor this week's list.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Nov. 5 through Nov. 11, including trial announcements from iVascular, Simplify Medical, Livongo Health, and Bio2 Technologies.

Promising new results from a pilot study of Abiomed’s Impella device to reduce damage after myocardial infarction sets the company up to start a pivotal study, which, if successful, could change how patients are treated immediately after an attack.

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.