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NeuroOne completes feasibility study of OneRF ablation system

NeuroOne Medical today announced it completed a feasibility study of its OneRF ablation system.

The feasibility study evaluated the OneRF ablation system that uses existing sEEG diagnostic electrodes for brain tissue lesioning. Researchers completed the study in an animal model. The research combined the sEEG electrodes with a proprietary RF generator. In addition, there was a unique temperature control accessory that monitored and maintained ablation temperatures. The temperature control accessory allows doctors to set the temperature and time for each ablation procedure.

Dr. Van Gompel and his team implanted five sEEG electrodes. They performed electrophysiological records and completed a total of 10 RF ablations using different settings for temperature and time. An MRI scan confirmed all ablations in the feasibility study.

“This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to …

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Fresenius Medical Care’s CEO leaves after two months in top spot

Carla Kriwet [Photo courtesy of Fresenius]Fresenius said Fresenius Medical Care (NYSE:FMS) CEO Carla Kriwet will leave the company “at her own request and by mutual agreement due to strategic differences.”

The Bad Homburg, Germany-based dialysis provider instead named Deputy CEO and CFO Helen Giza as the division’s next CEO.

When announcing Kriwet’s promotion and Giza’s new role of deputy CEO in May, Fresenius said it would enter into a new 5-year employment contract with Giza. Kriwet was set to replace longtime CEO Rice Powell on Jan. 1, 2023, with him stepping down as CEO of Fresenius Medical Care on Dec. 31 after hitting the company’s age limit.

But Kriwet took over on Oct. 1 with Giza assuming “certain functions of the role of chief executive officer for a brief interim period,” the company said in SEC filings on Oct. 31.

That same month, the company said it expected net income for the year to decline at …

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Moon Surgical wins first FDA 510(k) clearance for surgical robot

This screen grab from a Moon Surgical marketing video gives an idea of what the Maestro robotic surgery system looks like in action [Image courtesy of Moon Surgical]Moon Surgical announced today that it received FDA 510(k) clearance for its Maestro surgical robotics system.

Paris- and San Francisco-based Moon Surgical designed Maestro to support surgeons in soft tissue surgical procedures. Think of it as a robotic surgical assistant.

The small, adaptable system can integrate into existing clinical workflows. It features capabilities that bolster operating room efficiency and allow for alternative labor models, the company said.

In June, Moon Surgical completed a $31.3 million Series A fundraising. CEO Ann Osdoit said the company aims to make Maestro capable of use in any laparoscopy in any operating room. This could revolutionize minimally invasive surgery through collaborative and adaptive robotics.

Moon Surgical featured…

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Titan Medical to implement cost-cutting measures, furloughs 40 employees

Titan Medical (Nasdaq:TMDI) announced today that it plans to implement cost-cutting measures that include temporary furloughs.

News of cost-cutting follows last week’s announcement that Titan plans to review and evaluate strategic alternatives.

Toronto-based Titan develops single-access robotic-assisted surgery technology. It consulted with financial and legal advisors to determine that the review is in the company’s and stakeholders’ best interest. Titan’s board plans to consider a full range of strategic alternatives. That may include a corporate sale, merger or other business combination. It could also lead to a sale of all or a portion of its assets, strategic investment or other significant transaction.

According to a news release, Titan’s measures allow it to continue working on its FDA investigational device exemption (IDE) filing. As part of the plan, Titan’s U.S. subsidiary intends to temporarily furlough approximately 40 emplo…

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Sumitovant Biopharma merges its Enzyvant and Altavant subsidiaries

Enzyvant Therapeutics and Altavant Sciences today announced plans to merge to form a biopharmaceutical company focused on life-altering therapies for people with rare diseases.

Through the deal, the combined company will retain the name Enzyvant and will be equipped with a full range of capabilities spanning non-clinical and clinical development and commercialization. It is also in the process of developing in-house manufacturing. Enzyvant and Altavant Sciences are wholly owned subsidiaries of Sumitovant Biopharma.

Enzyvant and Altavant CEO Dr. Bill Symonds will lead the merged company.

“Together, our combined team has the proven expertise to take a product from early clinical development through commercialization, and the passion and focus to drive accelerated development of urgently needed rare disease medicines in immunology and cardiopulmonology,” Symonds said in a news release. “Patients and families facing very serious and difficult-to-treat rare c…

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Activ Surgical wins CE mark for its enhanced surgical imaging system

Activ Surgical today announced it received CE Mark approval for its ActivSight Intelligent Light, ActivSight.

[Image courtesy of Activ Surgical]ActivSight is an easy-to-adapt module that attaches to laparoscopic systems to provide real-time, on-demand surgical insights integrated into standard monitors. It has multimodal advanced visualization for minimally invasive surgery to access critical intraoperative visual data as augmented reality overlays.

“As an early clinical advisor in the development of ActivSight Intelligent Light, I have seen first-hand the benefits it can provide me and my fellow surgeons in operating rooms around the world,” said Dr. Nicole Bouvy, surgeon and professor at Maastricht University Medical Center (MUMC+) in The Netherlands. “The system is seamless to use and allows for advanced visualization during surgery, which makes it an important additional tool to potentially reduce surgical complications. I am pleased that Activ Surgical obtain…

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Neuralink reportedly faces probe over animal testing

A screen grab from a Neuralink video of a monkey playing Pong through it’s brain-computer interface [Image courtesy of Neuralink]Elon Musk’s brain-computer interface venture Neuralink faces a U.S. Department of Agriculture Inspector General animal welfare investigation, according to Reuters.

Reuters cited sources familiar with the investigation and company operations. The sources said the Agriculture Department opened the probe at a request of a federal prosecutor.

The Reuters report described a high-pressure environment at Neuralink in which errors resulted in the need to repeat experiments, with more animals losing their lives as a result.

Reuters said it did not receive a response back from Musk and Neuralink. However, the company has an entire webpage about its commitment to animal welfare. It mentions that the company has never received a USDA citation. The webpage says:

“In the present day, we at Neuralink are privileged to have the…

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Cell Pouch System developer Sernova announces CEO transition

[Image from Sernova]Sernova announced today that, as part of a planned leadership succession process, Dr. Philip Toleikis will transition out of the CEO role.

Toleikis spent 13 years leading the Cell Pouch System developer as president and CEO. He remains an executive at the company as the planned transition moves him to chief technology officer (CTO). Additionally, Toleikis will remain CEO during the company’s search period.

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

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Understanding the design of electromagnetic navigation technology

An example of an embedded electromagnetic (EM) sensor in a catheter tip [Image courtesy of Intricon]

As electromagnetic navigation becomes the top choice for surgical navigation, sensor and design considerations are critical.

David Bosch, Intricon

Since its inception in the 1990s to widespread adoption by the late 2000s, electromagnetic navigation (EMN) has emerged as the clear choice for surgical navigation and has been widely adopted in the fields of interventional bronchoscopy, urology, neurosurgery and cardiology.

A properly designed EMN system has several advantages. It can localize with the precision of optical tracking without the need for a line-of sight. It offers the convenience of fluoroscopy for intra-patient visualization without the application of ionizing radiation. And it does not expose the patient to energy fields that any more harmful than ultrasound.

Unlike alternative navi…

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Mapping epileptic seizures with new brain activity models

Sridevi Sarma is associate director of Johns Hopkins Institute of Computational Medicine and head of the Neuromedical Control Systems Lab [Photo courtesy of Johns Hopkins]

Johns Hopkins University researchers have developed new models for mapping epileptic seizures.

The models could help surgeons identify the precise location in the brain where the seizures originate (called “epileptogenic zones”) to improve treatment — and decide whether an operation is worth the risk.

“We want surgeries to go well, but we also want to prevent surgeries that may never go well,” Sridevi Sarma, associate director of Johns Hopkins Institute of Computational Medicine and head of the Neuromedical Control Systems Lab, said in a news release.

To develop the new technology, Sarma’s team created heat maps of brain activity when patients were not having seizures, as well as during stimulation with q…

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Vaxxas raises $23M for needle-free drug delivery tech

Vaxxas’ patch comes in a hockey-puck-shaped applicator with a foil seal. [Image courtesy of Vaxxas]Vaxxas announced today that it completed a financing round that brings in $23 million (A$34 million) in new funds.

Existing investors OneVentures and UniQuest led the round. New investors, including members of the Vaxxas board and management team, along with individual investors, participated. The company earmarked proceeds to advance its clinical programs, including its needle-free COVID-19 vaccine candidate.

Other potential uses include the installation of the company’s first manufacturing lines. These would offer the capacity to support Vaxxas’ first products through late-stage clinical studies and early commercial production.

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

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Imagen Technologies wins FDA nod for computer-assisted detection device

Left shows a chest radiograph. Right shows the output of FDA-cleared software, Aorta-CAD on the same chest radiograph. The software is identifying and highlighting aortic calcifications as suggestive of aortic atherosclerosis. [Image courtesy of Imagen Technologies]Imagen Technologies announced today that the FDA cleared its computer-assisted detection (CADe) device, Aorta-CAD.

New York-based Imagen designed Aorta-CAD to assist physicians in detecting findings on chest X-rays. Those findings may suggest the prevalence of aortic atherosclerosis and aortic ectasia.

The cloud-based, software-only medical device uses deep learning to detect and highlight its findings. According to a news release, it makes up part of Imagen’s diagnostics as a service (DaaS) platform. It assists any physician reading chest X-rays, including radiologists and primary care physicians.

Imagen’s fourth FDA clearance could lead to earlier and better detection and treatment …

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Pfizer seeks EUA for omicron booster for under-5 kids

Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5.

The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.

The U.S. is presently grappling with a “tripledemic” of COVID-19, flu and RSV, which can each cause respiratory distress in children. Pfizer and BioNTech said today that updated COVID-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would still receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine. After that, they would receive a third 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.

Pfizer and BioNTech are seeking a sim…

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Medtronic completes enrollment in pulsed-field ablation catheter trial

Medtronic’s Sphere-9 mapping and ablation catheter [Photo courtesy of Medtronic]Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech.

The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and navigation platform, it treats atrial fibrillation.

Affera designed the technology to diagnose, map and treat heart arrhythmias with ablation. It scars heart tissue to interrupt errant signals using both radiofrequency ablation and non-thermal pulsed-field ablation technology. Medtronic acquired the company for $1 billion in August.

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

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Roche Diagnostics North America appoints new CEO

Brad Moore. [Image courtesy of Roche]Roche (OTCQX:RHHBY)  announced today that it appointed Brad Moore as president and CEO of Roche Diagnostics North America.

Indianapolis-based Roche Diagnostics North America said Moore’s appointment becomes effective Jan. 1, 2023. He currently serves as SVP of core lab and point of care within Roche Diagnostics North America. He succeeds and reports to Matt Sause, whom Basel, Switzerland-based Roche recently named CEO of its global diagnostics business.

“Brad has a proven reputation for delivering outstanding results and is a highly effective leader,” said Sause. “I’m confident his experience will be a tremendous asset for the North America team, our customers and patients.”

Moore joined the company in October 2016. He initially joined as head of the company’s North American diabetes care business. In 2019, his role expanded to include Europe and North America commercial operatio…

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FDA tightens indications for Abiomed Impella RP system

The Impella RP Flex with SmartAssist. [Image from Abiomed]The FDA announced today that it is updating the labeling on Abiomed‘s Impella RP Flex with SmartAssist to reflect the final post-approval study results.

Abiomed announced in October that FDA had approved the catheter-delivered heart pump system to provide temporary right ventricular support for up to 14 days. People can develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Now, the FDA has updated the labeling (changes in italics):

“The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery, withou…

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Data backs gene therapy delivery system for treating type 2 diabetes from Fractyl Health

Fractyl Health today announced positive preclinical proof-of-concept data in an animal model for its gene therapy delivery platform for treating type 2 diabetes.

The company, which develops the Revita diabetes reversal procedure, evaluated its Rejuva program. Rejuva, a novel device and AAV-mediated delivery platform, delivers gene therapy directly targeting the pancreas. This potentially embeds multiple different pharmacologies to address serious metabolic diseases, including type 2 diabetes and obesity.

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

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FDA clears mixed reality surgical planning tool from apoQlar

A surgeon uses mixed reality to visualize 3D holograms. [Image courtesy of apoQlar]apoQlar announced today that it received FDA 510(k) clearance for its VSI HoloMedicine mixed reality software for surgeons.

Hamburg, Germany-based apoQlar designed VSI HoloMedicine to enable surgeons to plan complex procedures with 3D holographic technology.

According to a news release, FDA clearance makes the U.S. the 30th country to clear the apoQlar technology. The company intends to distribute in the U.S. through its Miami, Florida-based subsidiary. It expects commercial availability in the second quarter of 2023.

Following the clearance, apoQlar said it intends to raise a Series A funding round. It marks the medical metaverse company’s first-ever fundraising campaign as it looks to scale VSI HoloMedicine.

“With mixed reality, we are no longer bound to physical objects in a physical world,” said apoQlar co-founder and CEO Sirko Pelzl. “We ca…

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Medtronic begins distributing Acutus AcQCross sheath-compatible septal crossing devices

[Image from the Acutus Medical website]Acutus Medical (Nasdaq:AFIB) announced today that Medtronic (NYSE:MDT) intends to begin distributing its left-heart access devices.

In April, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million. That portfolio includes the AcQCross line of sheath-compatible septal crossing devices. It also features the AcQGuide Mini, AcQGuide Flex and AcQGuide VUE technologies.

Acutus said in June that it completed the first two closings of its deal to sell the devices to Medtronic. Last month, Acutus completed the first $20 million milestone under its asset purchase agreement with the medtech giant.

Beginning today, Medtronic intends to initiate distributing the products, having provided notice to Acutus of its intentions. Pursuant to the distribution agreement, Acutus ceased all distribution and sales of the left-heart devices to third parties, according to a news release. It now intends to manufacture …

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Mindray launches wearable patient monitoring system

[Image courtesy of Mindray]Mindray announced that it launched the mWear system for wireless, wearable patient monitoring of a range of vital signs.

Shenzhen, China-based Mindray designed mWear to enable an efficient workflow for monitoring patient conditions and delivering patient-centric care.

Mindray’s mWear system addresses shortages of beds and staff in today’s hospitals, according to a news release. It combines wireless interconnection with accurate multi-parameter monitoring, streamlined workflows and seamless integration. The company said it helps improve clinical outcomes throughout the patient journey.

The mWear system offers measurements of vital signs. Those include ECG, oxygen saturation, noninvasive blood pressure, respiration rate, pulse rate, and temperature. The system features anti-interference capabilities, allowing patients to move without restrictions. It also minimizes false alarms for clinicians to identify true abnormaliti…

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Ekso Bionics buys Indego exoskeletons from Parker Hannifin

The Indego Therapy lower-limb exoskeleton [Photo courtesy of Ekso Bionics]

The Indego exoskeleton deal includes all of Parker’s Human Motion and Control business and gives Ekso a new development partner.

Ekso Bionics Holdings (Nasdaq:EKSO) has purchased the Indego exoskeleton line and the rest of Parker Hannifin’s Human Motion and Control (HMC) business unit.

The $10 million deal includes the planned development of robotic-assisted orthotic and prosthetic devices, the companies said in a news release provided to Medical Design & Outsourcing ahead of today’s announcement.

“The strategic acquisition of Parker’s uniquely-powered and adjustable Indego exoskeletons significantly builds our product offering and extends our market opportunity to the home,” Ekso Bionics Executive Chair Steven Sherman said in a statement. “With the addition of HMC, we intend to grow our global foot…

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