In part 2 of an interview, we follow up with last week’s guest, CVRx CEO Nadim Yared, to catch up on how the medtech executive is managing during the pandemic. Yared also shares some far-reaching views on what the medtech industry needs to work toward to improve diversity in its workforce and provide equality for […]
Soterix wins IDE for depression treatment trial
Soterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial of its tDCS-LTE) neuromodulation system. New York-based Soterix Medical’s transcranial direct current stimulation-limited total energy (tDCS-LTE) system is an at-home platform for people suffering from major depressive disorder (MDD). The proprietary technology is designed to support the home-based tDCS, […]
CVRx raises $50m to support Barostim Neo commercialization
CVRx has raised $50 million in its latest round of equity financing — money the company will use to support the U.S. commercialization of its Barostim Neo heart failure treatment device. New investors Strategic Healthcare Investment Partners and Vensana Capital led the new funding round — with participation from other new investors, Hatteras Venture Partners […]
CVRx’s Yared speaks to the value of confidence and cooperation
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 […]
GTX Medical appoints new CEO
GTX Medical this week said it appointed Dave Marver as chief executive officer. Marver has more than 15 years of experience in various leadership roles at Medtronic and has also held leadership positions at Cardiac Science Corporation and has co-founded two startup companies in orthopedics and sports technologies. “GTX is the clear leader in developing […]
CVRx reports positive six-month trial results for Barostim Neo
CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure. Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve […]
Masimo announces drug-free opioid-withdrawal device
Masimo (NSDQ:MASI) announced that it received FDA de novo classification for its Bridge neuromodulation-based opioid withdrawal device. Bridge uses neuromodulation to aid in reducing the symptoms associated with opioid withdrawal. Irvine, Calif.-based Masimo touts it as the first evidence-based, drug-free, non-surgical device of its kind. The wearable, single-patient-use, percutaneous neurostimulator fits behind the ear and applies […]
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, […]
FDA approves Mainstay Medical neurostim device
Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
CEO Ryan explains how Cala Health is building bioelectronic medicine business
In this week’s episode of DeviceTalks Weekly, Tom Salemi, editorial director of DeviceTalks events and content, visits with Renee Ryan, the CEO of neuromodulation startup Cala Health. Ryan came to Cala from the venerable medtech investor Johnson & Johnson Development Corp., where she made over 15 investments helping to create companies including Auris Surgical, Cala […]
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