The Trump administration is prioritizing reforms to improve the reimbursement process for medical devices, and it is willing to spend money to do it. That's according to Joe Grogan, the health program associate director for the White House Office of Management and Budget. See what he said about it here.

A device manufacturer wouldn’t violate anti-kickback law by offering hospitals a refund if their joint replacement fails for patients, the Department of Health & Human Services’ Office of the Inspector General said in a recent advisory opinion.

A patient advocacy group recently met with US FDA officials to ask for new safety measures, if not a total ban, around LASIK eye surgery. See what the group's coleader, Paula Cofer, said about the dangers of LASIK here.

US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.

The top health official at the White House Office of Management and Budget says the Trump administration is committed to clearing barriers that stand in the way of reimbursement for new medical technology. “We’re doing a lot of work on medical device stuff that nobody knows about, trying to figure out how America can maintain our dominance," Joe Grogan said Sept. 20.

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

US FDA's ongoing Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which assesses device-makers' manufacturing maturity and capability, has become so popular that both the agency and manufacturers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members, or ATMs, to assist in device-related Capability Maturity Model Integration (CMMI) appraisals.

A trio of new chief financial officers were hired, at Allurion Technologies, Lumicell and QuantuMDx. Precision Therapeutics expanded its recently formed Scientific Advisory Board, and at Insulet Corp., there will be new leadership in the top spot come January.

The Transcatheter Cardiovascular Therapeutics meeting held in San Diego featured late-breaking trials of new stent technologiesincluding TALENT, BIONYX, BIOFLOW-V, SORT-OUT IX, LEADERS FREE II and ReCre8.

Find out where the medtech money is flowing in our weekly roundup. Among other deals, Medtronic makes a mammoth acquisition to buy the remaining shares of Israeli surgical robotics firm Mazor Robotics and Israeli company MeMed secures $70m to advance its point-of-care immune system diagnostic for distinguishing between bacterial and viral infections.

Industry fundamentals to date suggest the device sector as a whole should be doing more to go all-in on digital and data analytics. That's the takeaway from EY's annual "Pulse of the Industry" report for the medtech space.

Medtronic is straightening up as a market leader in spinal surgery after agreeing to buy the shares of Mazor Robotics that it does not already own. The $1.3bn deal builds on an existing agreement between the companies formed in May 2016 and strengthens Medtronic as the front runner in the spine robotics field.

A lawsuit over negative pressure wound-therapy devices ended in a win for plaintiff KCI Medical Services after an Ohio federal judge ordered Healthcare Essentials Inc. to pay $645m for alleged theft. See what Judge Benita Pearson wrote about the case here.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the five added this week, Neuronix's NeuroAD Non Invasive Cortical Enhancer technology was approved in Australia for use in Alzheimer's patients, in combination with "tailored cognitive therapy."

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Sept. 17 through Sept. 23, including trial announcements from Boston Scientific, MedAutonomic, Desiral, and Edwards Lifesciences.

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

Results Recap is a new regular feature in Medtech Insight providing a summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition includes trial announcements from NeuroMetrix, Vertos, LivaNova, and Boston Scientific.

A new guidance from the UK's National Institute for Health and Care Excellence (NICE) concludes that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement. The NICE guidance came as LivaNova announced completed enrollment in the 900-patient, randomized PERSIST-AVR trial of its Perceval sutureless aortic valv.

The US Centers for Disease Control and Prevention's new clinical recommendations for health-care providers treating children with concussions or mild traumatic brain injury (mTBI) advise physicians against using advanced imaging for diagnosis. See what the CDC's Deb Houry said about the guidelines here.