The House Energy and Commerce Committee approved four opioid crisis-related bills that call for US FDA meetings and consideration of streamlined pathways for medtech alternatives to opioids, and for a report and action by the US Medicare agency on overcoming payment challenges to device pain control products.

The new executive group chair of the Competent Authorities for Medical Devices will help steer EU medtech through one of the trickiest times in its regulatory history, as the key national authorities group loses its UK lead.

German maker of the Twion Power Push-Rim Power Drive System cited for quality systems violations; RADLogics was marketing its AlphaPoint software without pre-market approval or clearance from US FDA.

The May 25 deadline for the EU's General Data Protection Regulation is rapidly approaching. See what attorneys Renzo Marchini and Robert Fett have to say about some of the considerations for medtech companies.

The US Trade Representative office's decision in March to include devices, imaging machines and diagnostics on a list of Chinese imports destined for a 25% tariff has riled up the industry. A half-dozen medtech organizations protested the move in comments and testimony this week, supplying USTR with 12 reasons why the tariffs are a very bad idea.

There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."

A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.

Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this updated feature article.

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, with 343 initiated. Moreover, there were 208.4 million units recalled in Q1 '18 – more units than in all of 2017. Check out our Q1 recalls infographic.

Liquid biopsy marquee player Grail Inc. has reported results of several proof-of-concept approaches to cancer screening that achieved high specificity, and a handful of smaller-scale cancer-specific tests are already available. See what Thomas Rodgers of Grail investor McKesson Ventures had to say about it here.

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced May 7-13, 2018.

Company stock will make up the "vast majority" of Mike Weinstein's compensation for being Medtronic's new senior VP of strategy. CEO Omar Ishrak said Medtronic's evolving executive compensation policies are an element of the firm's efforts to improve value to shareholders. See what Ishrak said about it here.

While liquid biopsy is becoming routine for cancer treatment stratification and monitoring, using blood tests to screen for early cancer in asymptomatic people remains a tantalizing target. Some question how practical such a test could be but several companies are already en route - some further down the road than others - to achieve this goal. Illumina spin-out Grail is one of these companies and while it is not alone, in a field where size matters, it may have an advantage. This article delves deeper into how these different technologies work and when they could reach the market.

Medtech M&A activity dipped in April from last month but brought in a number of high-value acquisitions. Highlights included Fresenius, the world's largest dialysis firm, selling its majority shareholding in Sound Inpatient Physicians Holdings for $2.15bn to investment firm Summit Partners. 

Derived from Strategic Transactions, Informa’s premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech highlights notable technology alliances, R&D partnerships and commercial collaborations. In this edition, we look at industry pacts that were sealed in March and April 2018.

Results of a study showed that Impulse Dynamics' Optimizer device significantly improved exercise tolerance and quality of life in certain heart-failure patients. See what principal investigator (and cardiologist) William Abraham of Ohio State University said about those patients here.

The FIX-HF-5C trial, a subgroup study derived from the FIX-HF-5 pivotal trial, shows that the Impulse Dynamics Optimizer cardiac contractility modulation device significantly improved exercise tolerance and quality of life in certain heart-failure patients. Results of the trial were presented at the Heart Rhythm Society conference in Boston. Impulse Dynamics expects to file the final PMA module for US FDA for Optimizer in June.

Johnson & Johnson has added the Embotrap clot retrieval device to its US offering after the product got FDA clearance. It will compete with Medtronic's Solitaire and Stryker's Trevo, which are already on the US market.

iSTAR Medical reported six-month clinical trial data supporting its latest micro-invasive glaucoma surgery device, MINIject.

Oncimmune has expanded its offering in the US with the launch of a blood-based liver cancer test, the second product to emerge from its EarlyCDT platform.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between May 7 and 13, 2018, including announcements from BioCardia, Akili Interactive Labs, Arch Therapeutics, and Acutus Medical.