The Medical Device Innovation Consortium has formed a strong bond with US FDA over its joint Case for Quality initiative. See what new MDIC CEO Pamela Goldberg said about the group's ongoing search for quality here.

Respondents to a consultation by the Therapeutic Goods Administration on how to adequately regulate personalized medical devices are against the proposed introduction of an application and approval process. But they do favor other proposals that would bolster the rules, particularly for 3D-printed products.

While the Supreme Court announced this week that it won’t hear a case related to off-label billings, other False Claims Act-related suits may still be on the docket.

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.

On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

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.

Medtech's number one player Medtronic reported solid fourth-quarter results, beating market analysts' forecasts and wrapping up a strong fiscal year 2018. Star performers in the final quarter were its diabetes and restorative therapies businesses.

Direct-to-consumer genetic testing company 23andMe has filed suit against competitor Ancestry.com, alleging that the AncestryDNA kit infringes on 23andMe’s patent. The company further alleges that Ancestry.com is violating laws against false advertising.

Varian Medical Systems' proposed $1.3bn deal to acquire SirTex Medical is officially in jeopardy after China's CDH Investments formalized its rival bid to snatch away the Australian interventional oncology firm. Should the deal fall through, what would Varian's next steps be?

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.

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.

Single-center data presented at the Heart Rhythm Society annual meeting in Boston raised questions about failure rates for Abbott Laboratories's Tendril pacemaker leads. See what Baptist Health electrophysiologist John Mandrola said about it here.

Medtronic looks to be back on track with its renal denervation plans, after announcing its Symplicity Spyral system got off to a good start with positive six-month results in the SPYRAL HTN-ON MED pilot study. The data, presented at EuroPCR 2018 in Paris, showed that Symplicity Spyral was able to reduce blood pressure significantly in hypertensive patients prescribed anti-hypertension medications, with no major adverse safety events out to six months.

Robocath is planning a year-end market launch of its flagship R-One robotic catheterization system after the preclinical trial of R-One hit all primary endpoints. If the product is CE-marked in December as anticipated, it will be a rival to Corindus Vascular's CorPath, which is currently the only robotic-assisted system in the market for interventional cardiology. Robocath announced the preclinical data at EuroPCR in Paris, being held this week until May 25.

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.

The 2018 Heart Rhythm Society scientific sessions in Boston covered a variety of presentations of new electrophysiology clinical data, including a report on the failure of St. Jude's Tendril leads, a meta-analysis of contact-force catheters for atrial-fibrillation ablation, and new data on Medtronic's Micra leadless pacemaker.