This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure. The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology. In this week’s DeviceTalks Weekly podcast, […]
Axonics’ SNM system wins FDA nod for 3T-MRI scans
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system. The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental […]
FDA approves Medtronic’s latest DBS
Medtronic (NYSE:MDT) said today that it has received FDA approval for the Percept PC deep brain stimulation (DBS) system. The medical device giant is touting Percept PC’s BrainSense technology, which is designed to sense and record brain signals while delivering DBS therapy to people with neurological disorders such as Parkinson’s disease. BrainSense enables more personalized, […]
Medtronic wins CE mark for TAVI system in low-risk patients
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system. Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for […]
MedTech 100 roundup: Another rebound as markets continue to fluctuate
Medtech stocks rebounded from a significant dip earlier in June last week, continuing to highlight the topsy-turvy nature of the markets during the COVID-19 pandemic. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 85.00 points at the end of last week (June 19). That total represents […]
DeviceTalks Weekly: Stryker CEO Kevin Lobo says medtech can increase workforce diversity
This week’s DeviceTalks Weekly podcast episode talks with industry leaders about improving worker diversity and developing new ways to treat COVID-19 patients. Kevin Lobo, chairman and CEO of Stryker, explains how his company — and the industry group AdvaMed that he currently leads — has been working to increase diversity of its workforce, particularly in […]
Medtronic, Foxconn aim to make 10,000 ventilators
Medtronic (NYSE:MDT) and Foxconn said today they will boost ventilator production to 10,000 over the next year at Foxconn’s Wisconsin plant. The companies announced in April that Foxconn would begin production of Medtronic’s Puritan Bennett 560 ventilators at the plant in Mount Pleasant, Wis., with a goal of 400 ventilators per week by the end of April and 700 per […]
Medtronic touts results of venous self-expanding stent system study
Medtronic (NYSE:MDT) announced that the clinical trial for its Abre venous self-expanding stent system met its primary safety and effectiveness endpoints. The Abre stent system is designed for treating patients with iliofemoral venous outflow obstruction. The prospective, interventional, single-arm, multi-center, global trial with 200 subjects across 24 sites evaluated primary patency at 12 months for effectiveness […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
Abbott, Medtronic go head-to-head at ADA conference
Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology. The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller […]
States reportedly fend for themselves with inflated ventilator prices
States had to scramble to obtain ventilators after the White House left them to fend for themselves, according to a Kaiser Health News report. Demand for intensive care unit ventilators skyrocketed as healthcare facilities dealt with the surges of COVID-19 patients over the course of the pandemic, which still goes on today after gaining steam […]
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