While the US Senate Appropriations subpanel handling FDA funding plans to mark up a 2020 funding bill for the agency on 17 September, disagreement between the Senate and House on agency spending caps could delay the final funding accord between the two chambers, forcing the FDA to run on continuing resolution dollars in early October.

In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc.

An initial version of real-world data project NESTcc – the National Evaluation System for health Technology Coordinating Center – is expected to be open for business and ready to take unsolicited proposals by the end of the year.

Providers and suppliers to Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) are required to disclose any affiliations they've had with individuals who've committed fraud under federal health-care programs under a final rule released on 10 September.

Obstetricians and maternal health research experts at a 10 September US House hearing on ways to lower maternal mortality rates supported passage of H.R. 2602, which would promote greater use of telemedicine as a means for expectant and new mothers to gain mental-health counseling and health-care advice from providers, among other provisions.

Devices to treat diseases and conditions affecting many more Americans are eligible for Humanitarian Use Device status under a new guidance document.

There were 200 recalls initiated by device-makers in the second quarter of 2019, a 22% increase over Q1, when 164 were reported. Conversely, the number of recalled device units fell from 135 million in Q1 to 19.7 million in Q2 – a decrease of 85%. Check out our Q2 recalls infographic.

A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation compares regulatory requirements found in the US FDA's QSR to those in quality systems standard ISO 13485:2016. While the 146-page document is aimed at US device-makers, it could also be helpful to the FDA as the agency works to harmonize its QSR with the ISO standard.

Concerns about paclitaxel-coated balloons and stents, as well as recalls linked to two large device manufacturers, captured the attention of many of our online readers last month, as did compliance-focused features that offered tips and advice from US FDA officials. Here are August's 10 most popular US regulation and policy stories from Medtech Insight.

Seqster developed a technology platform that integrates data from electronic medical records, DNA and genomic information and fitness wearables into one place. See what Seqster's CEO, Ardy Arianpour, said about it here.

The companies signed a deal to allow Novo Nordisk’s smart insulin pens to share insulin dosing data with Medtronic’s continuous glucose monitoring devices. Novo Nordisk's smart insulin pens are already compatible with all other major brands of continuous glucose monitors.

San Diego, CA-based software-as-a-service company Seqster developed a technology that integrates data from electronic health records, genomics and wearables into one platform. Seqster's CEO Ardy Arianpour believes he has solved a major interoperability problem and hopes to attract providers, payers and pharma companies as clients.

Baxter International is buying Israeli fluid-management company Cheetah Medical in a $230m deal set to expand Baxter’s patient monitoring portfolio. See what Baxter's David Ferguson said about it here.

Baxter International is buying Israeli company Cheetah Medical in a $230m deal. The acquisition expands Baxter’s portfolio of medication delivery products.

A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.

The first large randomized trial of drug-coated balloons to treat hemodialysis arteriovenous access stenoses showed Medtronic's IN.Pact AV paclitaxel-coated angioplasty balloon produces superior outcomes compared to standard angioplasty balloons. See what one of the trial’s primary investigators, Andrew Holden, said about it here.

Results of a study in over 11,000 patients shows Abbott’s MI³ algorithm can risk-stratify patients with suspected myocardial infarction and help doctors decide which patients are most likely to benefit from earlier clinical decisions.

The US FDA cleared a smartphone-based urine test for diagnosing chronic kidney disease. Israeli company Healthy.io developed the digital testing kit that enables smartphone cameras to act as clinical grade medical devices.

The In.Pact AV paclitaxel-coated balloon outperformed plain angioplasty balloons in the IN.PACT AV Access trial, the first large, multi-center randomized trial comparing a drug-coated balloon to standard balloon angioplasty in the treatment of hemodialysis arteriovenous access stenoses.

A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.

Dreem 2 is a biofeedback headband with seven sensors that measure brain activity, heart rate, respiration and movement that works with a mobile app to help users improve the quality of their sleep.