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.

Hong Kong has issued new guidance and an updated code of conduct on the roles and responsibilities of entities wanting to be listed as a local responsible person.

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.

In an exclusive interview with Medtech Insight, MDMA's Mark Leahey – one of industry's top lobbyists – talked about the group's priorities over the past year and its continued work on hot-button issues, including medical device-tax repeal, reimbursement and implementing MDUFA IV provisions. He also discussed the imminent departure of US FDA Commissioner Scott Gottlieb and the recent federal government shutdown.

US FDA's Center for Devices and Radiological Health will finally launch a long-planned reorganization that will see agency staff grouped by device types, rather than by stage in the device-review cycle. The reorganization begins this week and should be complete by Sept. 30.

The journey from medtech concept to implementation is long and slow, and new ideas often don’t make it all the way to manufacturing and approval. But when they do, what is needed is a system that guarantees adoption and usage of those proven, innovative solutions that clear the many hurdles en route to clinical practice.

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.

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.

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.

Cardiva Medical believes it's in a unique position to help the growing number of patients who undergo catheter-based cardiovascular procedures requiring relatively large catheters, especially electrophysiology procedures like cardiac ablation. See what Cardiva CEO John Russell said about EP procedures here.

The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.

In this edition of Device Week, Medtech Insight’s Catherine Longworth discusses Smith & Nephew’s $660m acquisition of regenerative medicine company Osiris Therapeutics. And Reed Miller talks about the clinical trial highlights from the recent CRT Meeting in Washington and looks forward to the American College of Cardiology conference next week.

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the second of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including clinical trial data on devices from Abbott Laboratories, Medtronic, Medi-Lynx, and iRhythm. See Part 1 of our ACC Results Recap for more on the groundbreaking trials of transcatheter aortic valve replacement in low-risk patients and the Apple Heart study of Apple Watch's ability to track atrial fibrillation.

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.

Makers of next-generation sequencing tests often have a hard time finding somatic reference samples to use when developing their products. To help sponsors find those samples, the Medical Device Innovation Consortium with help from US FDA has developed a guide that aggregates reference samples to help validate their tests.

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.