US FDA Commissioner Scott Gottlieb spoke with Medtech Insight about the agency’s decision to put the LDT issue to Congress instead of using guidance-making.

Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.

New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells Medtech Insight how Denmark is setting up a unique data analytics center for medical devices and drugs without reinventing the wheel.

Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

The US agency is approving 30-day change notices at a breakneck pace for device-makers enrolled in an ongoing program that measures manufacturing maturity and quality using an industry-modified version of the Capability Maturity Model Integration (CMMI) framework. FDA also says it has waived 40 routine and four pre-approval inspections as part of the program – a help not only to device firms, but to the agency as it considers where best to use its scarce inspectional resources.

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

Patient-monitoring company Nonin Medical and cancer genomics testing firm Contextual Genomics both hired new CEOs; blood-filtering device firm ExThera Medical appointed a scientific advisory board; and more.

In this week's Results Recap, covering trial data from the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, Martin Leon from Columbia University presented results from the PARTNER 3 trial, comparing Edwards Lifesciences Corp.'s balloon-expandable Sapien 3 transcatheter aortic valve system to open valve surgery. See what Martin Leon from Columbia University said about it here.

Scott Zellner, senior director at DePuy Synthes, and orthopedic surgeon Joel Matta, who has been collaborating with DePuy since 2004, have long advocated for the anterior approach to total hip replacement, touting the many benefits of the minimally invasive surgery. Medtech Insight sat down with Zellner and Matta at this year's American Association of Orthopedic Surgeons' (AAOS) conference in Las Vegas to discuss the company's latest technologies designed for the anterior approach to total hip replacement, what's next, and to hear Matta's view on the widely discussed role of robotic-assisted surgeries.

In this week's Results Recap covering trial data from the American Academy of Orthopedic Surgeons Annual Meeting in Las Vegas March 12-16, Myoscience released encouraging preliminary results from a 125-patient study on its Iovera cryoanalgesia therapy. See what the presenter of the results, William Mihalko, from Campbell Clinic of Germantown, Tennessee, said about it here.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Bard’s Venovo venous stent system for symptomatic iliofemoral venous outflow obstruction, FDA added functional mitral regurgitation to the approved labeling for Abbott’s market-leading MitraClip, and Watchman FLX, Boston Scientific’s next-generation left-atrial appendage closer earned a CE Mark in Europe.

Data from the AF-FICIENT I study, presented at the European Heart Rhythm Association in Lisbon, Portugal, support Boston Scientific's development of the Luminize atrial fibrillation ablation catheter. Luminize has built-in digital cameras for visual guidance and sensing electrodes on the balloon to assess real-time vein isolation.

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition covers new clinical data released March 8 to March 22, not including the data presented at the annual conferences of the American Academy of Orthopedic Surgeons or American College of Cardiology, which are presented in separate special editions of Results Recap.

In this week's Results Recap, covering trial data from the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, Martin Leon from Columbia University presented results from the PARTNER 3 trial, comparing Edwards Lifesciences Corp.'s balloon-expandable Sapien 3 transcatheter aortic valve system to open valve surgery. See what Martin Leon from Columbia University said about it here.

In this week's Results Recap covering trial data from the American Academy of Orthopedic Surgeons Annual Meeting in Las Vegas March 12-16, Myoscience released encouraging preliminary results from a 125-patient study on its Iovera cryoanalgesia therapy. See what the presenter of the results, William Mihalko, from Campbell Clinic of Germantown, Tennessee, said about it here.

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of three special Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from March 4 through March 17, including trial announcements from CardioFocus, Innovative Cardiovascular Solutions, IntraLink-Spine, Geneveve, Acutus, and Stereotaxis.

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This is a special edition covering trial data presented during the first three days of the American Academy of Orthopedic Surgeons Annual Meeting, held in Las Vegas March 12-16, including presentations on devices from Stryker, Miach, Myoscience, CyMedica, and Reflexion Health.