What Synchron leaders learned from developing a stent-based BCI

This close-up shows one of the electrodes on Synchron’s Stentrode brain implant. [Image courtesy of Synchron]

Synchron’s efforts to develop, manufacture and commercialize its groundbreaking brain-computer interface system holds lessons for device developers who are designing increasingly miniaturized implants for minimally invasive delivery.

In recent months and years, we’ve asked Synchron leaders to share their advice as they studied the safety of their nitinol Stentrode implant, refined the implant’s design and manufacturing process, and launched a clinical trial under an investigational device exemption from the FDA, which previously awarded Synchron with breakthrough device designation.

‘Take it step by step’

In a wide-ranging interview with Medical Design & Outsourcing, Synchron CEO and co-founder Dr. Tom Oxley offered some advice specifically for device desig…

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Who is Acquandas? Its thin film manufacturing goes beyond Synchron

This nitinol thin film actuator made by Acquandas with a film thickness of 50 µm can pull 550 times its own weight. [Image courtesy of Acquandas]

Acquandas is a thin-film device manufacturer that’s now partially owned by brain-computer interface developer Synchron.

Rodrigo Lima de Miranda founded Acquandas in 2012 based on microsystem technology he developed for his doctoral thesis, where he was trying to develop a shape memory material made with thin-film deposition.

The Kiel, Germany-based contract manufacturer now uses the Nanolab cleanroom facilities at Kiel University and is growing its team of around 22 employees.

Beyond neurotech applications like Synchron’s Stentrode, the Acquandas technology has promising potential for cardiac ablation, renal denervation, opthamology, nerve stimulation, passive microimplants, microneedles, and smart actuators and springs, Lima de Miranda said …

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BCI developer Synchron buys stake in thin film maker Acquandas

The Stentrode endovascular electrode array for brain-computer interface [Image courtesy of Synchron]Synchron, a developer of brain-computer interface (BCI) technology, today announced the acquisition of an equity stake in Acquandas.

Acquandas, a German-based company, specializes in high-precision components for healthcare and other industries.

The company bases its metallic components on state-of-the-art microsystem technology processes. It fabricates thin film components for applications in medical devices, including micro-patterned nitinol thin films. They feature high structure resolution, high geometrical complexity, strong biocompatibility and improved mechanical properties.

“As we pioneer functional endovascular neurotechnology, this investment strengthens our technology innovation and supply chain for our unique product offerings, beginning with brain-computer interfaces,” said Tom Oxley, Synchron founder and CEO.

As part of the transaction, O…

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January 2024 edition: The Leadership in Medtech issue


Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

How Recor Medical won the renal denervation race for FDA approval

Medtech’s biggest personnel moves of 2023

Leadership and innovation in medtech

Creativity, energy, agility — those are three words Recor Medical CEO Lara Barghout used to describe the culture at the world’s first device developer to win FDA approval for hypertension-treating renal denervation (RDN).

You can add persistence to that list. Ever since its founding in 2009, Recor Medical and its team has been pushing to deliver a safe and effective RDN system. The seemingly long odds got longer as larger competitors pulled the plug on their own programs — or in Medtronic’s case, pushed on despite clinical trial failures and won approval shortly after Recor.

Our annual Leadership in Medtech issue of Medical Design &a…

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New Synchron CTO Riki Banerjee on BCI manufacturing and outsourcing

Synchron Chief Technology Officer Riki Banerjee [Photo courtesy of Synchron]

After 12 years in Medtronic’s neuromodulation operating unit and two years as R&D VP at Synchron, Riki Banerjee is the brain-computer interface (BCI) developer’s new chief technology officer.

More electrodes and thinner electrodes were always goals at Medtronic. But neuro device makers across the industry have faced the difficulties of developing chronic implants for stimulation, as well as designing interconnects to bridge the implants with the rest of the physical system.

“I think we’re on a good path to be successful” at Synchron, Banerjee said in an interview with Medical Design & Outsourcing in 2023 before she was promoted to CTO.

Related: Synchron’s plan to beat Neuralink in the neuroprosthetic BCI race


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BCI developer Synchron names new chief technology officer

Synchron Chief Technology Officer Riki Banerjee [Photo courtesy of Synchron]Synchron has promoted Riki Banerjee to chief technology officer, replacing co-founder Nick Opie in the role.

Opie will remain on the brain-computer interface (BCI) developer’s board of directors, the company said today.

Banerjee joined Synchron as VP of R&D in September 2021 after 12 years with Medtronic’s neurovascular operating unit. She will now lead all of Synchron R&D activities, including advancing the company’s neuroprosthesis device for patients with severe paralysis.

“Riki has been an instrumental part of Synchron’s growth and has also been the driving force behind our product design,” Synchron CEO and co-founder Dr. Tom Oxley said in a news release. “She is a senior leader at the intersection of neuromodulation innovation, engineering, implantable medical devices and commercialization. Her expertise and leadership will be transfo…

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BCI maker Synchron adds former Dexcom CEO to its board

Andy Rasdal [Image courtesy of Synchron]Brain-computer interface (BCI) developer Synchron announced today that it appointed medtech veteran Andy Rasdal to its board of directors.

Rasdal brings more than 30 years of experience in developing and commercializing novel medical devices. He previously served as CEO of Dexcom, a leader in the continuous glucose monitor (CGM) space. There, he led the company through FDA approval and a successful IPO on the way to commercializing its CGM technology.

Currently, Rasdal serves as executive chair of Epitel, which develops a wearable, wireless EEG system to detect seizure conditions. He also led Obalon through FDA approval, an IPO and the commercialization of an obesity product as founding CEO.

Other previous roles include president of Medtronic’s Vascular unit. Rasadal also served as VP of global marketing at Arterial Vascular Engineering, which Medtronic bought for $4.3 billion. He also held positions at EP Techn…

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Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

Dr. Tom Oxley, CEO and co-founder of breakthrough brain-computer interface developer Synchron, discusses advances in minimally invasive neurointervention, medtech leadership, advice for device developers, and ethics at the bleeding edge of BCI technology.

Synchron co-founder and CEO Dr. Tom Oxley giving a TED Talk with an image of the Stentrode device displayed behind him. [Photo courtesy of Synchron]

What seems like a miracle today — a paralyzed patient regaining the ability to communicate with their family without open-brain surgery — may eventually seem obvious in retrospect.

It already does to Dr. Tom Oxley, the interventional neurologist who’s CEO and co-founder of brain-computer interface (BCI) developer Synchron.

Synchron’s Stentrode device is implanted inside a blood vessel in the brain to sense neural signals and relay them to another implant in the chest. Those signals are then tran…

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Synchron’s plan to beat Neuralink in the neuroprosthetic BCI race

Synchron Chief Commercial Officer Kurt Haggstrom [Photo courtesy of Synchron]

Competing brain-computer interface (BCI) developers Synchron and Neuralink both announced big news this month as they move their dueling neuroimplant technologies forward.

The device developers each have FDA investigational device exemption (IDE) for their experimental BCIs. They’ve also got billionaires backing their R&D and regulatory efforts, with Neuralink owned by Elon Musk and Synchron funded by Jeff Bezos and Bill Gates.

This month, Synchron announced the completion of patient enrollment in its COMMAND clinical trial. Two weeks later, Neuralink announced the start of recruiting for its own clinical trial, the PRIME first-in-human study.

With BCI technology advancing as one of the hottest spaces in medtech innovation, Synchron Chief Commercial Officer Kurt Haggstrom discussed the competitive landscape and…

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Synchron completes patient enrollment in brain-computer interface trial

The Stentrode endovascular electrode array for brain-computer interface [Image courtesy of Synchron]Synchron announced today that it completed patient enrollment in the COMMAND clinical trial for its brain-computer interface (BCI).

The U.S.-based trial operating under FDA investigational device exemption (IDE) enrolled six patients in total. Synchron says it’s the first IDE awarded by the FDA to assess a permanently implanted BCI. The early feasibility study assesses safety while evaluating quantified efficacy measures of the Synchron Switch motor neuroprosthesis. It evaluates patients with severe paralysis.

Synchron says the primary goal is to assess if the device can be safely implanted into the blood vessels of the brain through neurointerventional procedures. The company also designed the study to evaluate how BCI may enable the use of thoughts to control digital devices. For patients who can no longer use their hands, this could help achieve daily tasks…

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Synchron says study backs its brain–computer interface’s safety

The Stentrode endovascular electrode array for brain-computer interface [Image courtesy of Synchron]Synchron’s stent-like brain-computer interface is getting a boost from new clinical study results out of Australia.

JAMA Neurology today published peer-reviewed, long-term safety results involving four people with severe bilateral upper-limb paralysis. Twelve months after having Synchron’s Stentrode implanted inside a blood vessel in the brain, there were no adverse events. In addition, there was no vessel occlusion or device migration.

On top of the positive safety results, the Stentrode demonstrated it could work. All four patients’ BCI implants had stable signal strength throughout, with a mean (SD) signal bandwidth of 233 (16) Hz. There was offline decoding of at least five attempted movement types. Plus, each patient learned to successfully control a computer with the BCI.

“The SWITCH study is an early demonstration of safety in a low n…

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DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

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