The medtech industry has been lobbying the US Congress hard to approve a permanent repeal of the device tax this year, but with passage of another continuing resolution bill Thursday, legislators have left themselves just two more weeks in 2018 – until Dec. 21 – to finish up a must-pass spending bill for 2019 that could serve as a vehicle for repeal of the tax.

In a Dec. 6 blog post, US FDA officials continued pressing for a new system of diagnostics regulation that puts laboratory-developed test services (LDTs) on the same footing as IVD test kits, all under a new framework where only about 10% of tests would require pre-market review.

The first US FDA device advisory panel to address a product on FDA's Breakthrough Devices program overwhelmingly supported Impulse Dynamics NV's Optimizer Smart system, an implant that delivers cardiac contractility modulation to patients with heart failure. The recommendation came despite panel uncertainty during a Dec. 4 meeting as to whether there was enough trial data to prove safety and effectiveness. See what Bram Zuckerman, the director of FDA's division of cardiovascular devices, said about it here. 

Early results of a new study of 300 women who previously had breast implants, and a review of longer-term follow-up of patients who had their implants removed, found more patients have suffered autoimmune issues and connective tissue disease than have come out in FDA-mandated studies, according to the National Center for Health Research. NCHR was critical of FDA's and industry's approach to post-market surveillance of breast implants.

Market surveillance has historically been too fragmented around Europe, according to critics of the EU system, but the national authorities have been creating a new joint work program and are on the cusp of launching a new initiative.

There are fears that some countries may reject medical devices and IVDs that have been CE marked under the EU medical device directives, even though their registrations may still be valid. The European Commission is now trying to address this.

Stakeholders can still fill out a survey that asks for feedback on potential plans to retool international quality systems standard ISO 13485. The deadline for the survey was extended so the International Organization for Standardization (ISO) committee that oversees revisions to ISO 13485 can make a stronger case against opening it up for a rewrite.

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.

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.

The global market for vascular access site closure products is expected to reach $1bn in 2022, driven in large part by the rising prevalence of cardiovascular disease, the leading cause of death globally. The most dominant trend in this market is the development of vascular closure devices for larger arteriotomies. Large-bore procedures, such as transcatheter aortic valve replacement (TAVR) and endovascular aneurysm repair, will drive demand for vascular closure devices. Due to complications associated with active vascular closure devices, the use of passive vascular closure devices is on the rise. Check out our infographic for details.

An early investor in the Australian neurostimulation and neuro-diagnostic company Neurotech International is now the firm's CEO. And Photocure, focused on photodynamic technology for bladder cancer, hired a new chief executive from Ablynx.

Propeller Health bills itself as a digital respiratory therapeutics company, providing a mobile platform that communicates with sensors on patients' inhaler devices to help them manage chronic obstructive pulmonary disease and asthma. This the second major acquisition ResMed has announced in the last month.

Aria CV hopes to address pulmonary hypertension, a potential devastating condition that currently has few treatments, with a unique balloon device that requires no power supply, battery, pump, or synchronization. See what Aria CEO John Scandurra said about it here.

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, from Nov. 26 - Dec. 2, 2018.     

As the date for multibillion-dollar medical device bidding process for hospitals in Turkey gets closer, the government made an important change, dropping the condition that bids must cover the whole package of requested devices. This opens the way for partial bids that smaller companies might be able to handle.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include a new LimaCorporate should component, US approval of the Incraft aneurysm stent graft and a first-in-class newborn-screening diagnostic.

In this edition of Device Week, Medtech Insight managing editor Marion Webb discusses the ongoing research that could lead to 3D-printing of human replacement organs and reporter Catherine Longworth highlights the developments in “femtech,” medical technology primarily or exclusively for female patients.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. A electrical stimulator for GI disease is among devices that made the list this week. Also, a drought in original PMAs and panel-track supplements in the US.

The Center for Surgical Arts in Pittsburgh is amassing big-ticket medical devices to train residents and fellows in a variety of surgical specialties. See what Allegheny Health Network's Boyle Cheng said about the Center here.

Some big-name device-makers – Medtronic, Stryker, Karl Storz, Siemens and more – are donating expensive capital equipment to the Center for Surgical Arts, a modern teaching lab that boasts 21 bays for training residents and fellows in various types of surgery. The companies are doing this to not only nail down future customers, but to test new devices, as well. The Center also includes a Bose test frame that was used to help clear Alphatec Spine's Solus device with US FDA without a clinical trial. "Those can be multimillion-dollar studies. So, to be able to do that, and to have the FDA feel comfortable with that, is kind of a cool capability," says Dr. Donald Whiting, chair of the Allegheny Health Network Neuroscience Institute.

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.