The US House Appropriations Committee in 2019 wants to give FDA an additional $40m to boost its digital health oversight, $12m more to “create a competitive marketplace for device quality,” and instructs the agency to keep working with Congress on a new laboratory-developed test regulatory path.

The US agency will convene advisors this summer to reassess whether hospital and practitioner procedure volume requirements, currently a prerequisite for running a Medicare-covered transcatheter aortic heart valve replacement program, are warranted.

US FDA did not release any device-related warning letters the week of May 22.

H.R. 5806 – the "21^st Century Tools for Pain and Addiction Treatment" – passed the US Senate on May 17. It calls for a public meeting and guidances to streamline regulatory passage of opioid medical products, including devices. See what the bill's cosponsor, US Rep. Michael Burgess, said about it here.

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.

US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.

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.

At the one-year anniversary of "program alignment" – US FDA's ambitious reorganization of its inspectional body – the agency is pushing hard to train its investigators on an array of medtech products. In that spirit, FDA has asked manufacturers to willingly open their doors to its investigators so they can learn more about the type of devices the firms are making, says Blake Bevill, a program division director for program alignment. Industry group AdvaMed and health-care organization Medical Alley Association are also getting in on the action by helping investigators learn about an array of topics, including software, electrical engineering, validation and design.

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.

Neuromodulation technology specialist SetPoint Medical has appointed Ankit Shah, whose track record include stints at Intersect ENT and Medtronic, as head of commercialization and marketing.

Zimmer Biomet is offering a €25,000 cash prize to the winner of its second Connected Health Innovation Award, which is looking for a digital technology that can improve patient outcomes, as well as save costs, in musculoskeletal health care.

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 14-20, 2018.

The global infusion drug delivery market continues to be driven by the rising prevalence of chronic disease and associated obesity, coupled with a growing aging population. Technological advancements such as less invasive pumps, needlestick prevention features and miniaturization have also supported the growing demand, but obstacles such as safety and security issues remain. According to a new report by Meddevicetracker, the global market for infusion pumps and disposables will reach $9.9bn by 2022, a CAGR of 6.4% from 2017. This article takes an in-depth look at the overall infusion pumps market, and dives deeper into the three fastest-growing segments – insulin, enteral and disposable pumps – highlighting the key players and competitive landscape.

Turkish interventional cardiology solutions firm Alvimedica is set to expand significantly its manufacturing capacity in a bid to further strengthen its position in the global heart stents and valves sectors. The company has ring-fenced around $370m to build a new facility, and its investment will be further supported by incentives from the Turkish government.

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.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between May 14-20, 2018, including announcements from Helius Medical, Altair, EP Dynamics and Abiomed.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

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.

A PMA for the PneumRx ELEVAIR endobronchial coil system will be considered by a US FDA advisory panel in June, but there will likely be some questions about the data.

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.