Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor. The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology. Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients […]
Silk Road Medical appoints chief commercial officer
Stroke treatment developer Silk Road Medical (NSDQ:SILK) announced that it promoted Andrew Davis as its new chief commercial officer. In the newly created role at the Sunnyvale, Calif.-based company, Davis is slated to oversee Silk Road Medical’s global commercialization efforts by establishing near-term priorities and setting the long-term strategic direction for the organization, according to a […]
Balt receives CE Mark for flow diverting shunt
Balt announced that it received CE Mark approval for its Silk Vista flow diverting stent for treating patients with unruptured intracranial aneurysms. Montmorency, France.-based Balt designed its Silk Vista device for predictable and accurate deployment and high visibility under angiography, adding to its already-CE-Marked Silk Vista baby flow diverter, which has been approved in Europe […]
Magstim acquires high-density EEG tech from Philips
Transcranial magnetic stimulation tech developer Magstim recently announced that it has purchased the product portfolio of Electrical Geodesics from Royal Philips (NYSE:PHG). Financial terms of the deal were not disclosed. Magstim will acquire EGI’s hardware, software and sensor nets assets and will immediately manage global sales, service and support, maintaining a presence in EGI’s Oregon office. […]
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 […]
SpeechVive raises $1.5m for speech improvement device
SpeechVive announced today that it raised more than $1.5 million upon the completion of a convertible note as it looks to begin scaling its business. The West Lafayette, Ind.-based, Purdue University-affiliated medical device company develops treatments for speech conditions in people who suffer from chronic neurological diseases, such as Parkinson’s disease. SpeechVive’s device fits behind […]
Forest Devices partners with Alberta Health Services
Forest Devices announced that it entered into a partnership with Alberta Health Services (AHS) to improve healthcare delivery for stroke patients. Pittsburgh-based Forest Devices and Calgary, Alberta-based AHS aim to evaluate, implement and scale technologies that can improve patient outcomes and health system economics in Alberta throughout the five-year collaboration, according to a news release. […]
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention. Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects. […]
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 […]
Akili wins CE mark for digital ADHD treatment
Akili Interactive announced today that it received CE Mark approval for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD). Boston-based Akili’s prescription treatment is delivered through a video game experience as a way to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive […]
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