Experts predicted continuing fights over insurance protections for preexisting conditions, and that newly elected Democrats may oppose device tax repeal in 2019 and 2020, due to the potential loss of federal revenue to pay for expanded health care coverage.

The agency explains that most drug-use-related apps will be considered promotional labeling, but sponsors should sometimes seek advisory comment. US FDA is seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-drug-focused software.

The UK does not know which direction its future will take, with respect to its current leadership and its relationship with the EU, from one hour to the next. But if the EU/UK Brexit Draft Agreement is accepted, there will be some short-term relief for the medtech sector.

The number of countries to which the EU's MDR and IVDR will apply totals 33. But the regulations will impact many more markets than that, according to Erik Hansson, deputy head of the European Commission unit that oversees medical devices. See what he said here.

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.

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.

On this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of trials that announced results. He also gives an update of key clinical trial news from this week’s American Heart Association meeting in Chicago.

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.

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.

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.

China’s artificial intelligence-powered health-care ambition takes a new form, a 24-hour health clinic complete with a medicine dispenser that may eventually be coming to a city corner near you. Pharma companies are also continuing to build digital health services in the country as part of the health technology push.

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.