Synchron says study shows safety of its brain-computer interface implant

Synchron’s Stentrode device expands inside a blood vessel on the brain to relay motor signals [Illustration courtesy of Synchron]

Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input.

New York-based Synchron said the study — allowed by the FDA under an Investigational Device Exemption — demonstrated the safety of its brain-computer interface (BCI) technology. The device is delivered by catheter rather than the open-brain surgeries used by other neurotech developers like Elon Musk’s Neuralink.

Synchron uses the catheter to feed the Stentrode device through a patient’s vein to the blood vessels on the brain (the YouTube video below from 2021 shows the process). Then, th…

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FDA proposes new cybersecurity, supply chain and inspection laws for medical device manufacturers

Ventilators were in high demand during the first peaks of the COVID-19 pandemic. (Image from Raumedic)

The FDA today offered a slate of proposed laws for Congress to consider along with the agency’s $8.4 billion budget request for fiscal year 2023.

The legislative wish list includes several proposals that would affect medical device developers, manufacturers and distributors, including cybersecurity requirements for medical devices, mandatory supply chain reporting, remote inspections for FDA-regulated facilities and the destruction of dangerous imports.

Medical device cybersecurity

One proposal would require medical device manufacturers to design cybersecurity into their devices, such as the ability to update and patch software in a timely manner. Manufacturers would also need to provide cybersecurity assurance in premarket submissions, include a Software bill of Materials that tells patients …

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FDA’s $8.4B budget request includes supply chain, pandemic prep and cancer funding

A lab worker at a COVID-19 diagnostic facility [Photo courtesy of Amazon]

The FDA today said it wants a $2.1 billion funding bump as it released details of its $8.4 billion budget request for fiscal year 2023, which starts Oct. 1, 2022.

The budget request includes full funding of the agency’s fiscal 2022 budget request, plus new programs and initiatives that would affect medical device developers and manufacturers.

The FDA also offered complimentary legislative proposals such as cybersecurity requirements for medical device manufacturers, remote inspections and supply chain shortage reporting.

FDA budget request highlights for medical device developers and manufacturers include:

Pandemic preparedness

The request includes $1.6 billion in mandatory pandemic planning funding over five years, including resources for the FDA to “modernize its regulatory capacity by strengthening its …

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Key Tech names next CEO as co-founder plans to retire

Key Tech co-founder and CEO Jenny Regan [Photo courtesy of Key Tech]

Key Tech co-founder Jenny Regan plans to retire as CEO of the product development firm at the end of August, making way for VP of Strategy Alex Flamm to take her place.

Regan has been CEO since she and her co-founders launched the Baltimore firm in 1998. The company said it now has 75 interdisciplinary medical product designers and hundreds of clients in the medical technology industry, including Becton Dickinson, GE, Thermo Fisher, HemoSonics, GenMark and Abiomed.

Regan, who led Key Tech’s transition to a fully employee-owned company in 2019, will join the Key Tech Advisory Board.

“I’m incredibly proud of what we’ve built and how much good we’ve been able to do,” Regan said in an announcement posted to the company’s website last week. “I’m confident in our new leadership and will always be inspired by the talen…

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How to join the MDO Contributors Network

Some of the most valuable information in Medical Design & Outsourcing is found in the expert-authored MDO Contributors Network articles covering medtech innovation, design and manufacturing — and it’s all thanks to readers like you.

If you’d like to share the latest research, developments or lessons learned from your organization to inspire and empower other MDO readers, here’s a guide to get you started.

It all begins with a great idea. What uniquely relevant and useful knowledge or expertise do you have that could help others in the medtech industry? It might be as simple as covering the basics of how a commonly used component works, or something as complex as explaining the science behind cutting-edge breakthroughs. Skim our archives for some examples and remember that this is an opportunity to educate and share what you’ve learned, not to advertise your goods or services.

MDO Contributors Network requirements

Exclusivity B…

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Pulse field ablation enables new precision cancer treatments

A Minnetronix engineer evaluates a control board for an electroporation system. [Photo courtesy of Minnetronix]

Macro-scale electroporation energy manipulates cellular behavior for effective drug delivery.

Saeid Movahed and Daniel Friedrichs, Minnetronix Medical

When applied to tissue, electric fields can enable precise and selective ablation effects by manipulating cellular-scale electrical properties. One effect, called electroporation or electropermeabilization, has many therapeutic and diagnostic applications including tumor ablation and intercellular delivery of DNA, RNA, protein and other cargo.

The intercellular space is separated from the outside environment by phospholipid bilayer (cell membrane), which is an electrically polarized membrane made of lipid molecules. Transmembrane potential (TMP) — the inherent difference between electric potentials on the two sides of the cell membrane — can …

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What you need to know about the FDA’s Total Product Life Cycle Advisory Program pilot

An FDA initiative meant to enhance medical device development is closer than ever to becoming a reality after it survived negotiations with the industry over the Medical Device User Fee Amendments (MDUFA) reauthorization.

My last post on MDUFA V touched on the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot laid out in the regulatory agency’s commitment letter. Though the pilot could be modified or scrapped by the FDA after hearing from the public in April or by lawmakers as they consider reauthorizing MDUFA, the letter offers the program’s latest and most detailed outline.

“The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” the FDA said in the letter. “A mature TAP will also help ensure the sustained success of the breakthrough dev…

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This variable stiffness catheter could simplify cardiac procedures

Image courtesy of EPFL

Researchers in Switzerland have developed a variable stiffness catheter that can transition between soft and rigid states.

A team of researchers from technical university EPFL and ETH Zurich developed the catheter to make minimally invasive surgical interventions like cardiac arrhythmia treatment, simpler and more effective.

Catheters are inserted into arteries and navigated to treatment zones in many minimally invasive procedures. They can provide access to the heart without having to perform open-heart surgery. However, catheters can come with limitations.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Medtronic completes first patient implants in tibial neuromodulation trial for bladder control

Medtronic (NYSE:MDT) announced that it completed the first patient implants in the Titan 2 pivotal study of its investigational neuromodulation device.

Fridley, Minnesota-based Medtronic’s Titan 2 trial will evaluate the safety and efficacy of the company’s implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB).

Get the full story at our sister site, MassDevice.

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Sterifre Medical prepares to launch its Aura desktop disinfection device

The Sterifre Aura disinfection system [Photo courtesy of Sterifre]

Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system.

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of car…

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FDA releases MDUFA V details after industry negotiations

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA).

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MUFDA V commitment letter. For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years…

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FDA clears Quantum Surgical’s robot-assisted tumor ablation tech

[Image from Quantum Surgical]

Quantum Surgical announced today that it received FDA 510(k) clearance for its Epione interventional oncology robotics platform.

Montpellier, France–based Quantum Surgical designed Epione, a robot-assisted system, to plan, target, deliver and confirm tumor ablation in minimally invasive liver cancer treatment.

Get the full story at our sister site, MassDevice.

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