No device-related warning letters were released by the US FDA the week of 23 July.

Democratic presidential candidate Sen. Amy Klobuchar of Minnesota has long been a strong supporter of the medical device industry and has been fighting to repeal the 2.3% medical device excise tax instituted as part of the Affordable Care Act. However, she did not include it as a priority for her administration if she is voted into office in 2020, and seems to be distancing herself from the industry.

The US Medicare agency has decided that evidence is sufficient to cover ambulatory blood pressure monitoring to help diagnose hypertension in beneficiaries who suffer from white coat high blood pressure, and those with suspected masked hypertension.

Vigilance is one area where the European Commission is sharpening up tools and practices now, with one eye on the new medtech regulations, too. Here we summarize key aspects of latest developments of which industry needs to be aware.

Trying to meet standards that are currently in a state of flux and which are the source of more uncertainty adds another layer of stress to medtech manufacturers already trying to comply with an incomplete medtech regulatory structure.

The US FDA's Suzanne Schwartz says a new law might be the antidote to companies that willingly hide cybersecurity vulnerabilities to avoid concerning their customers. Check out her comments here.

A new consent decree requires an Arkansas distributor to stop selling medical devices and other FDA-regulated products after an inspection found rodents, insects and other animals at the company’s warehouses.

US FDA investigator Ben Dastoli sees medical device manufacturers making the same process validation mistakes over and over. Here are the top six validation problems he sees.

Peter Shearstone, VP of global quality assurance and regulatory affairs at in vitro diagnostic test-maker Thermo Fisher Scientific, is dismayed that only two IVD manufacturers are playing in the US FDA's Case for Quality Voluntary Improvement Program to measure manufacturing maturity and quality – and his firm isn't one of them. "Part of my challenge is moving my company toward proactivity, and if [CFQ VIP] can help do that, then I'd be hypocritical if I didn't embrace it," he says.

Intuitive Surgical reported on 18 July that worldwide da Vinci procedures were up about 17% in the second quarter of 2019 compared to the same period of 2018. While the US still accounts for the majority of Intuitive’s revenue, procedure volume outside the US is growing faster, especially in Asia.

Orthopedic implant company Arthrosurface is hoping to get hand surgeons' attention with its new allograft thumb implant to treat osteoarthritis.

Abbott Laboratories plans to invest significantly to expand manufacturing capacity for its FreeStyle Libre continuous glucose monitoring system in an effort to meet demand. See what Abbott CEO Miles White said about it here.

SetPoint Medical is developing vagus nerve stimulation technology for Crohn’s disease and rheumatoid arthritis and believes it will be a "platform technology" for treating a variety of autoimmune diseases.

Abbott delivered solid sales growth in the second quarter of 2019, topping analyst expectations. The company reported worldwide sales of $8bn, up 2.7% with Medical Devices highlighted as a standout division, delivering 10.5% organic growth.

A crop of new US consumer protection state laws and proposed federal legislation is aimed at stopping medical specialists from the practice of balance billing.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, the US FDA approved a panel-track PMA supplement for an expanded indication for MED-EL’s cochlear implant, and Novian Health’s Novilase breast cancer treatment earned a CE mark.

Siemens Healthineers and the University of Missouri System and Missouri Health Care entered a 10-year strategic alliance worth $133M to collaborate on research projects, develop student curricula and leverage digital technology to drive health care. 

New final guidance from the US FDA sets out the agency’s expectations for the use of live-case presentations during device clinical trials, focusing on patient protection.

The growth potential of liquid biopsy diagnostics is drawing increasing attention, with several recent breakthrough device designations from the US FDA, big funding rounds, and major acquisitions all in play.

A new analysis suggests that Boston Scientific Corp.'s Watchman left-atrial appendage closure device is a cost-effective alternative to warfarin or other anticoagulant drugs for patients with atrial fibrillation. See what Vivek Reddy of the Mount Sinai Hospital said about it here.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 2 July to 8 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, de novos, or non-US approvals.