Fast Five: Precision Neuroscience’s BCI wins FDA breakthrough nod, Medtronic names new neuromodulation president

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 6, 2023.

Fast Five by MassDevice · Precision Neuroscience’s BCI wins FDA breakthrough nod

Nuro this week announced it achieved communication with a locked-in patient with its neurotechnology. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the technology and what allows the patient to communicate.

Biotronik published positive data for its spinal cord stimulation technology. Whooley explains the technology and what some of the most important data points were from the study.

Dexcom has launched its next-generation G7 continuous glucose monitor in Canada. Hear when the device is slated to hit the market, who it’s designed for and what executives think about the launch.

Medtronic appointed a new president of neuromodulation this wee…

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Biosense Webster: Catheter ablation leads to lower heart failure risk in AFib patients

Johnson & Johnson’s Biosense Webster today announced data supporting the use of catheter ablation in AFib patients.

The study, funded by the Irvine, California-based company, looked at heart failure incidence risks in AFib patients. It compared the use of catheter ablation versus antiarrhythmic drugs (AAD). Looking at non-specific catheter claims information, it showed catheter ablation’s association with lower heart failure risks compared to AAD only.

Biosense Webster says that several clinical studies highlight catheter ablation as a safe and superior alternative to AAD when performed appropriately. However, the company says less than 5% of the eligible population receive the procedure.

The study used the 2014-2022 Optum Clinformatics database to identify adult patients with AFib who previously used AAD. It classified them into two cohorts: those treated with catheter ablation versus those who received an AAD. The study matched the grou…

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FDA wants more testing in Philips recall

The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG) + .

The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.)

Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga.

FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming.

“Th…

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New data shows consistency of Medtronic MiniMed 780G in different demos, cultures

The MiniMed 770G system. [Image from Medtronic]Medtronic (NYSE: MDT) + today announced real-world data demonstrating the global consistency of its MiniMed 780G automated insulin delivery system.

The data demonstrates that using the system allows people with diabetes to meet or exceed internationally recommended targets regardless of location. Medtronic says a barrier to automated insulin delivery (AID) adoption and reimbursement in developing and middle-income countries has been a lack of data supporting its performance and cost-effectiveness in those regions. This comes as a result of large disparities in ethnic, cultural and regional representation in clinical and real-world studies.

Medtronic said its successful results support calls to provide AID systems within underserved populations. Data came from more than 67,000 MiniMed 780G users in Europe, the Middle East, Africa, Latin America, Oceania and Asia. The company p…

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Clarix Imaging raises $10M for surgical oncology imaging tech

Clarix Imaging announced that it secured $10 million in funding to support its volumetric specimen imaging system.

The state-of-the-art, point-of-care 3D imaging platform enables the real-time assessment of surgical specimens in the operating room. Its uses include oncology, with the potential to benefit the 300,000 patients diagnosed with breast cancer in the U.S. each year.

Clarix said in a news release that it’s seen a surge in demand for its platform since commercialization. It plans to use the funds from Kineo Finance, plus an upcoming equity financing round, to foster growth and development.

The Clarix platform utilizes unique image reconstruction technology for imaging at high, isotropic resolution with significantly reduced scan time. It enabled Clarix to create a portable system to meet space and time demands within the operating room workflow. This way, surgeons receive rapid verification of the excision of the correct tissue.

Clar…

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Nuro achieves communication in locked-in patient with its neurotechnology

A model of the NUOS Extreme 2 eyewear with neurological sensors. [Image from the Nuro website]Nuro announced that a teenager with amyotrophic lateral sclerosis (ALS) regained some communication ability with its technology.

The fully locked-in patient, referred to as “J,” is completely incapacitated by the debilitating disease. Using the company’s NUOS Extreme 2 system, the 17-year-old girl from Chicago controlled critical communication, music and video content. She achieved this using thought control, without any surgery, training or calibration.

Previous efforts saw attempts to assist J with a number of tools. At first, she had the ability to communicate with an eye gaze system. However, that technology became unreliable and ultimately failed, Nuro said in a news release.

The Waterloo, Ontario, Canada-based surgery-free neurotechnology developer then provided the first implementation of NUOS Extreme 2. This enabled the girl to instantly r…

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Biotronik has positive data for its spinal cord stimulation tech

The Prospera SCS system. [Image courtesy of Biotronik]Biotronik today announced positive results from a clinical trial for its Neuro Prospera spinal cord stimulation (SCS) system.

The BENEFIT-02 trial evaluates the Resonance multiphase stimulating paradigm used in the Neuro Prospera system. It looked at the safety and effectiveness of the stimulator in treating patients with chronic pain.

Contrary to other currently available SCS therapies, Resonance requires less power and uses a proprietary integrated circuit design. It delivers a continuous, spatially and temporarily distributed therapeutic pulse pattern across the spinal cord.

Biotronik’s prospective, multicenter, randomized, single-blind feasibility study included participants with chronic low back and/or leg pain. They presented a baseline numerical rating scale (NRS) for overall pain intensity greater to or equal to six. After a successful commercial SCS trial, Biotronik randomized patients to …

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Precision Neuroscience wins FDA breakthrough nod for BCI, buys factory in Texas

[Image from Precision Neuroscience]Precision Neuroscience announced today that its brain-computer interface (BCI) technology won FDA breakthrough device designation.

The company also acquired a microelectromechanical systems (MEMS) foundry outside Dallas, Texas. Completed through its Precision BioMEMS subsidiary, the acquisition brings its supply chain in-house. It also establishes Precision as a leading-edge manufacturer of biomedical MEMS in the U.S., according to a news release.

Precision Neuroscience develops the Layer 7 Cortical Interface, designed with 1,024 tiny electrodes spanning an area of one square centimeter. The company embedded the electrodes in a flexible film that conforms to the brain surface. This film — one-fifth the thickness of a human hair — is designed for implantation and removal by neurosurgeons without damaging brain tissue.

The company designed it to map a large area of the brain’s surface at resolutions higher than typical neuro…

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Dexcom launches next-gen G7 CGM in Canada

The G7 CGM. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + today announced the commercial launch of its next-generation G7 continuous glucose monitor (CGM) in Canada.

The San Diego-based company expects to make its latest CGM technology available to Canadians on Oct. 10, 2023. It covers people with all types of diabetes aged two and older, including those who are pregnant, in the country.

G7 received FDA clearance in December 2022 and Dexcom launched the device in the U.S. in February of this year.

Get the full story at our sister site, Drug Delivery Business News.

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Fast Five: Medtronic says some defective video laryngoscopes were stolen and offered for sale illegally, Insulet CFO steps down

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 5, 2023.

Fast Five by MassDevice · Medtronic says some defective video laryngoscopes were stolen and offered for sale illegally

Surgical robotics are in the news again today. This time, Microsure announced it raised $40 million to advance its microsurgical robot. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the robot does and what the financing means for the company. Read more here>>

Organ transportation developer Paragonix is expanding its headquarters and has opened its new one in Waltham, Massachusetts. Hear what the expansion reflects for the company and what the new HQ will have. Read more here>>

Butterfly and Razom are expanding their existing partnership to bring more handheld ultrasound systems to Ukraine. Whooley explains…

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How Onward is combining spinal cord stimulation with BCI to restore movement

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward] The brain-computer interface space has taken medtech by storm. This novel approach from Onward has the potential to bring it to another level.

Several companies are developing brain-computer interfaces (BCIs), many of which offer people with paralysis a chance to control external devices with their mind. Onward, a Dutch medtech company, develops technology that could utilize BCIs to go even further.

Onward’s ARC-IM stimulation system delivers targeted, programmed therapy to the spinal cord. It aims to restore movement and other functions after spinal cord injury. Combined with BCI technology, the company believes it could restore thought-driven movement.

The BCI works in tandem with ARC-IM to capture the intention of a paralyzed individual to move their upper extremities. It uses artificial intelligence (AI) to decode those thoughts and convert the information into ARC-IM therapy. Precise sti…

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Medtronic has a new president of its Neuromodulation business

Paolo Di Vincenzo. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it appointed Paolo Di Vincenzo as the president of its Neuromodulation business.

Di Vincenzo’s appointment at Medtronic goes into effect on Oct. 30. In his new role, he holds responsibilities for the overall strategic direction of the company’s neuromodulation business and day-to-day operations.

Neuromodulation is part of Medtronic’s Neurosciences portfolio, comprised of Pain Interventions and Brain Modulation. The unit engineers innovative therapies and technologies to help patients relieve pain, restore function and reclaim movement.

Di Vincenzo joins Medtronic from Smith+Nephew, where he served as SVP and GM of U.S. advanced wound management. Over nine years at the orthopedic giant, he also served in global marketing and leadership roles.

Before Smith+Nephew, Di Vincenzo held a number of marketin…

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