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Implant Therapy Articles & Analysis

16 news found

Synchron Announces First Human U.S. Brain-Computer Interface Implant

Synchron Announces First Human U.S. Brain-Computer Interface Implant

The procedure marks the first U.S. patient implant in Synchron’s COMMAND trial, which is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. ...

BySynchron, Inc.


Synchron Appoints Kurt Haggstrom as Chief Commercial Officer

Synchron Appoints Kurt Haggstrom as Chief Commercial Officer

I am eager to bring my experience to Synchron to help support its mission of developing an endovascular implant that can transfer information from every corner of the brain at ...

BySynchron, Inc.


Team Gleason Partners with Synchron to Redefine Accessibility

Team Gleason Partners with Synchron to Redefine Accessibility

“Our recent results presented at the American Academy of Neurology Conference 2022 show that our permanent BCI implant is safe, and can improve independence and quality of life for those living with ...

BySynchron, Inc.


Synchron Announces Enrollment of First Patient in U.S. Endovascular Brain Computer Interface Study COMMAND in Patients With Severe Paralysis

Synchron Announces Enrollment of First Patient in U.S. Endovascular Brain Computer Interface Study COMMAND in Patients With Severe Paralysis

The device also stayed in place for all four patients and the blood vessel in which the device was implanted remained open. Following implantation in the SWITCH clinical trial, patients were able to use the Stentrode system unsupervised in their homes to send text messages, conduct online shopping and manage their finances. About the Stentrode Synchron’s ...

BySynchron, Inc.


Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode for Severe Paralysis

Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode for Severe Paralysis

Four Patients With ALS Who Received Stentrode™ Implant Gained Ability to Perform Daily Online Tasks No Serious Adverse Events Reported after 12 Months Synchron, a brain computer interface (BCI) company, today announced the results from a study in which four people with ALS received an implant of Synchron’s Stentrode™ device, a ...

BySynchron, Inc.


Synchron Expands Advisory Board as Brain-Computer Interface Device Stentrode Advances into Patients in US Clinical Trials

Synchron Expands Advisory Board as Brain-Computer Interface Device Stentrode Advances into Patients in US Clinical Trials

Synchron is the only company to receive FDA approval to conduct clinical trials of a permanently implanted BCI. The company’s novel BCI technology leverages the blood vessels as the natural highways to the brain. ...

BySynchron, Inc.


NeuroSigma Receives FDA Breakthrough Device Designation for Monarch eTNS System®

NeuroSigma Receives FDA Breakthrough Device Designation for Monarch eTNS System®

Clinical trials of the device in patients with DRE have shown impressive results comparable to those achieved with adjunctive pharmaceutical and implantable device therapies,” commented Dr. Colin Kealey, President of NeuroSigma. “This Breakthrough Device Designation will expedite completion of a pivotal trial of external trigeminal nerve stimulation ...

ByNeuroSigma, Inc.


PolyActiva Announces Positive Phase IIa Trial Results in Low Dose Cohort for PA5108 Ocular Implant with Prezia Sustained Drug Delivery Technolog

PolyActiva Announces Positive Phase IIa Trial Results in Low Dose Cohort for PA5108 Ocular Implant with Prezia Sustained Drug Delivery Technolog

Statistically significant and clinically meaningful mean change in diurnal IOP at 12 and 26 weeks (p<0.001). Implant persistence through a minimum of 21 weeks with full implant biodegradation by week 40, over a 4-6 week period. Low dose implant shown to be generally well tolerated with no ocular serious adverse events related to product, no ...

ByPolyActiva Pty Ltd.


Promaxo Announces Sale of In-Office MRI to Kasraeian Urology

Promaxo Announces Sale of In-Office MRI to Kasraeian Urology

The Promaxo system reinforces our practice goals as it not only allows us to refine our biopsies, but also facilitates MR-guided therapies within the comfort of our offices and ambulatory surgery center. ...

ByPromaxo, Inc.


Synchron announces first direct-thought tweet, “Hello World,”using an implantable brain computer interface

Synchron announces first direct-thought tweet, “Hello World,”using an implantable brain computer interface

Synchron, a brain computer interface company, today announced a Twitter takeover by Philip O’Keefe, one of the patients implanted with the Stentrode brain computer interface. Mr. O’Keefe is the first person to successfully message the world on social media directly through thought using an implantable brain computer interface. ...

BySynchron, Inc.


World’s First Watchman ProcedurewWithout the Use of Contrast Dye

World’s First Watchman ProcedurewWithout the Use of Contrast Dye

Procedure removes risk of kidney injury or complications in patients with advanced kidney disease or allergy to contrast dye On Sept. 30, CentraCare completed the world’s first contrast-free WATCHMAN implant using 4D holographic therapy guidance, developed by EchoPixel, as the alternative imaging modality. ...

ByEchoPixel, Inc.


GT Medical Technologies Presents Clinical Data on GammaTile® Therapy for Brain Tumors at the 2021 American Association of Neurological Surgeons Scientific Virtual Meeting

GT Medical Technologies Presents Clinical Data on GammaTile® Therapy for Brain Tumors at the 2021 American Association of Neurological Surgeons Scientific Virtual Meeting

Mehee Choi, director of Medical Affairs at GT Medical Technologies, will discuss new data in patients with recurrent glioblastoma (GBM), and access-to-care for patients with resectable brain tumors. GammaTile is an implantable radiation therapy consisting of bioresorbable collagen tiles embedded with Cesium-131 sources provided by Isoray, Inc. ...

ByGT Medical Technologies, Inc.


Synchron receives green light from FDA to begin breakthrough trial of implantable brain computer interface in US

Synchron receives green light from FDA to begin breakthrough trial of implantable brain computer interface in US

Patients begin using the device at home soon after implantation and may wirelessly control external devices by thinking about moving their limbs. ...

BySynchron, Inc.


Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ...

ByAlleviant Medical, Inc.


Bonutti Technologies presents work at ATPA CSM 2018

Bonutti Technologies presents work at ATPA CSM 2018

Justin Beyers will be presenting at CSM 2018 on a poster titled: “Effects of Therapeutic Ultrasound on the Stability of Cemented Simulated Implants. The poster authored by Dr. Peter Bonutti, Justin Beyers, Tonya Bierman, Matt Cremens, and Nicole Tipsword explores the effect of therapeutic ultrasound on cemented implants. The American Physical ...

ByBonutti Technologies


Flowonix Medical and Cerebral Therapeutics Announce Fifth Implant of First-of-a-Kind Implantable Drug Therapy to Treat Patients with Refractory Epilepsy

Flowonix Medical and Cerebral Therapeutics Announce Fifth Implant of First-of-a-Kind Implantable Drug Therapy to Treat Patients with Refractory Epilepsy

In December 2016, the first patient was implanted in the trial, and she continues to receive the therapy today. ...

ByFlowonix Medical Inc.

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