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 UK is the middle of a week of Brexit votes in Parliament, but confusion for medtechs and the wider industrial community has not been quelled at all, regardless of two days of voting already, and a third to come today.

Following in the footsteps of the European Medicines Agency, Canada has launched a publicly-accessible portal to proactively disclose clinical trial information on approved medical devices and drugs that was hitherto considered confidential.

A coalition of 27 Senators – including 10 Democrats led by Amy Klobuchar, D-Minn. – on March 7 co-sponsored a bill to permanently repeal the device tax. AdvaMed says support of additional Democrats on this year’s bill should persuade Senate leaders to bring S. 692 to the floor for a vote, or it could be attached to other, "must pass"’ legislation. But the bill’s approval in the Democratic-controlled House is uncertain. Sixty-five of 283 “yes,” voters – mostly GOP – favoring tax repeal in the last session, are no longer in office.

Norman "Ned" Sharpless, director of the National Cancer Institute, will lead US FDA as its acting commissioner when agency head Scott Gottlieb steps down next month. See what Health and Human Services Secretary Alex Azar said about the appointment here.

HHS Secretary Alex Azar was pressed on issues tied to the Affordable Care Act and the recently proposed FY 2020 budget at a March 12 congressional hearing.

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.

Total Thermal Imaging, a company that promotes thermal imaging technology over mammography to detect breast cancer, says it is surprised the agency is coming after them for "illegally marketing" their test for unapproved indications. The company says it thought it had complied with all of FDA’s requirements but  is willing to consider filing a 510(k) if needed.

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.

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.

The current annual global manufacturing market for liquid biopsy is roughly $170m – representing a 90% yearly increase since 2015 – and it's expected to reach about $1bn by 2023. See what DeciBio Consulting's Mika Wang said about it here.

Cardiva Medical is taking advantage of the growing demand for products that safely and quickly close the access sites created for catheter-based electrophysiology procedures and other large-catheter cardiac procedures. The company has a sales staff entirely dedicated to its line of closure devices for multi-site venous closure for 6-12 French inner diameter sheaths, and is investing in clinical trials to show how these devices can improve patients’ recovery time and reduce the risk of complications.

Ultrasonic surgical platform firm Misonix appoints chief operating officer; a chief marketing officer leaves Medtronic for a place at continuous glucose monitoring system company Senseonics; food allergy biopharma firm DBV Technologies adds a scientific advisor; and more.

Osso VR partnered with Smith & Nephew to develop a VR training tool that will be showcased at this year's American Association of Orthopedic Surgeons' (AAOS) conference, taking place in Las Vegas from March 12-16. Orthopedic robotic systems continue to draw high interest from surgeons. The recent US FDA clearance of Zimmer Biomet's ROSA total knee replacement system will add competition to the current market dominated by Stryker's MAKO and Smith & Nephew's NAVIO.

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.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Vertos Medical gains a CE mark for its spine stenosis procedure kit, and US approvals for BD and Saranas.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by MedDeviceTracker. This edition covers Feb. 25 through March 3. Rani Therapeutics announced the first-in-human experience with its novel drug-delivery capsule Feb. 28.

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 22 through Feb. 28, includes published results from trials of Medtronic’s closed-loop artificial pancreas, Neuroelectrics’ nerve stimulation device to treat seizures, and Myriad’s companion diagnostic for pancreatic cancer.