MassDevice Archives - Medical Design Sourcing

Monteris launches smallest brain laser probe on the market

The Monteris Medical NeuroBlate NB3 FullFire 1.6mm laser probe can be used for oncology and epilepsy brain ablation. [Image courtesy of Monteris Medical]Monteris Medical today said its launch of the NeuroBlate NB3 FullFire makes it the smallest laser probe for brain procedures on the market.

The 1.6mm laser fiber probe features patented NeuroBlate System cooling technology and is available in a single adjustable length.

Minnetonka, Minnesota-based Monteris won FDA 510(k) clearance to add the NB3 to its NeuroBlate system’s devices and accessories in December 2023 and started a limited market release in February.

“Surgeons participating in the initial launch phase used the probe across a comprehensive set of workflows, lesion types, sizes, locations, target depths and patient profiles,” the company said in a news release. “Lesion types include primary tumors, progressive metastatic lesions, radiation necrosis and epileptogenic foci in …

GE HealthCare launches ‘new era’ of AI-enhanced oncology solutions

GE HealthCare (Nasdaq: GEHC) + today announced the launch of its “new era” of AI-enhanced oncology solutions, known as Revolution RT.

Revolution RT is a new radiation therapy computed tomography (CT) solution with innovative hardware and software solutions to increase imaging accuracy and simplify simulation workflow. The Chicago-based company designed the technology to create a more personalized and seamless oncology care pathway experience for clinicians and patients. The technology was showcased at the European Society for Therapeutic Radiology and Oncology 2024 Congress in Glasgow, Scotland.

The company also launched an updated and artificial intelligence (AI)-enhanced version of the Intelligent Radiation Therapy Platform (iRT) that interfaces with the Spectronic magnetic resonance imaging Planner.

“At GE HealthCare, we are committed to advancing the frontiers of oncology treatment through AI-dri…

MMI’s Symani surgical robot used in first U.S. clinical cases

MMI’s Symani system for robotic-assisted microsurgeries has tiny instruments operated by a surgeon using OperaAir controllers. [Photo courtesy of MMI]MMI (incorporated as Medical Microinstruments) today announced the Symani surgical robotics platform’s first clinical cases in the U.S.

The two robotic-assisted microsurgical procedures were performed at Penn Presbyterian Medical Center’s Department of Orthopaedic Surgery.

Pisa, Italy-based MMI won FDA de novo classification for the Symani Surgical System in April. The system secured a CE mark in 2019 and has racked up nearly 1,000 clinical cases in the EU as of last month.

Related: 10 surgical robotics companies you need to know

The first U.S. cases were reconstructive extremity microsurgeries, MMI said in a news release.

“In one case, the team performed a ‘free bone transfer’ procedure on a patient who suffered a traumatic injury; the proc…

Advice for building a medtech career inside a big company from BD CTO Elizabeth McCombs

BD EVP and Chief Technology Officer Elizabeth McCombs [Photo courtesy of BD]In the opening keynote for DeviceTalks Boston 2024 today, BD (NYSE:BDX) + EVP and Chief Technology Officer Elizabeth McCombs offered advice for building a medtech career inside a big company.

Reflecting on her 20-year career at Johnson & Johnson MedTech (the world’s second-largest medical device manufacturer) before joining BD, McCombs advised aspiring medtech leaders to strive to deeply understand customers and the clinical state “almost as well as the customer.”

“It’s easy in a big company to get internally focused and get caught up in the technology,” she said in a live interview with DeviceTalks Editorial Director Tom Salemi. “But when we take the time to define an important need and then solve it, that’s where the success comes.”

“We can get ahead of ourselves with our car…

Magnus Medical launches Saint neuromod system for major depressive disorder treatment

Magnus Medical this week announced the commercial launch of its Saint neuromodulation system for treatment-resistant major depressive disorder (MDD).

The Saint treatment changes a patient’s brain circuitry to treat MDD more effectively. It modifies activity in brain networks that are related to depression.

Saint won FDA breakthrough device designation and has FDA 510(k) clearance. According to the company, the therapy has led to dramatic improvements in people’s symptoms of severe depression in a clinical setting.

“We are thrilled to be the first site in the nation to offer the breakthrough, FDA-cleared Saint neuromodulation system for individuals suffering from depression, and I am very optimistic that this new approach will change people’s lives,” said Dr. Laura Dunn, chair of the Department of Psychiatry and director of the Psychiatric Research Institute at the University of Arkansas for Medical Sciences. “The innovative Saint protocol pro…

Teleflex announces limited launch of Wattson Temporary Pacing Guidewire

Teleflex (NYSE: TFX) + this week announced the limited market release of its Wattson Temporary Pacing Guidewide.

The limited market release commenced at Columbia University Irving Medical Center and was used in its first cases under the guidance of Dr. Tamim Nazif, Director of Clinical Research, Dr. Susheel Kodali, Professor of Medicine and Director of the Structural Heart and Valve Center, and Dr. Isaac George, Surgical Director of the Heart Valve Center.

Teleflex’s Wattson Temporary Pacing Guidewires have dual functionality to support valve delivery and ventricular bipolar during structural heart procedures. It can be used in transcatheter aortic valve replacement and balloon aortic valvuloplasty procedures.

Wattson offers a procedural alternative that Teleflex designed to avoid potential complications, steps and costs associated with traditional right ventricular pacing. It has a flexible distal pigtail…

Thermoforming vs. injection molding considerations for medical robotics enclosure cost and efficiency

As the medical robotics industry continues to advance, considerations surrounding the selection of the thermoforming or injection molding process play an important role in ensuring the safety, efficacy, and reliability that development teams work so hard to realize and refine.

Given the complexity and cost of attaining FDA approval for a medical device, companies want to maintain that initial manufacturing investment for as long as possible before the inevitable redesign and resubmittal process. Therefore, your enclosure manufacturing process selection should consider startup cost vs materials vs anticipated growth of product sales.

In the thermoforming process, a plastic sheet is heated and drawn over (male tool), or into (female tool) a mold to form a rigid shape. This process is assisted by pulling a vacuum from the underside, and optionally adding pneumatic pressure on the top side. The excess sheet material is then trimmed off and, if necessary, sc…

Cook Medical launches Ascend single-use ureteroscope in U.S., Canada

[Image courtesy of Cook Medical]Cook Medical this week launched its Ascend Single-Use Flexible Ureteroscope in the U.S. and Canada.

The launch allows the company to better serve more urology customers with a complete portfolio of stone management products.

Bloomington, Indiana-based Cook Medical designed Ascend to always be ready to use. It eliminates common issues in reusable ureteroscopes, including scope fatigue, reprocessing and missing or broken parts.

“The Ascend ureteroscope makes Cook a single destination for stone management disposables. As a single-use scope, Ascend is the perfect complement to our portfolio. Physicians can complete procedures faster because they won’t have to wait for scopes to be reprocessed; Ascend is always ready,” Johan Lowinger, director of product management for Cook’s Urology specialty, said in a news release.

Ascend has numerous features to help surgeons perform complex urologic procedures. It has…

Stryker beats The Street as strong sales growth continues

Stryker (NYSE: SYK) + is continuing a strong 2024 amid the continued success of its Mako robots, new joint replacement technology and more.

Kalamazoo, Michigan–based Stryker — the world’s largest ortho device company — earned $788 million, or $2.05 per share, off of $5.2 billion in sales for the quarter that ended March 31, 2024. The results represented a 33% boost to the bottom line and a 9.7% boost to the top line compared with Q1 2023.

Adjusted to exclude one-time items, Stryker saw earnings per share of $2.50 during the first quarter. The adjusted EPS was 15¢ ahead of the Wall Street analyst consensus of EPS of $2.50 and revenue of $5.1 billion.

“Our momentum from 2023 continued into the first quarter as we delivered 10% organic sales growth,” Stryker CEO Kevin A. Lobo said in a news release that was out yesterday evening. “Our teams are executing well, and I am confident in our abil…

Abbott has a new Vascular division CMO

New Abbott Vascular Chief Medical Officer Dr. Ethan Korngold. [Image from Ethan Korngold on LinkedIn]Abbott (NYSE: ABT) + has appointed Dr. Ethan Korngold as its new divisional VP of medical affairs and chief medical officer for its Vascular business.

Korngold succeeds Dr. Nick West, who spent four years as CMO and divisional VP of global medical affairs at Abbott Vascular. West departed in September to become associate chief medical officer at Shockwave Medical, which Johnson & Johnson is now acquiring.

The new CMO joins Abbott with more than 20 years of medical practice. He most recently served as medical director of interventional cardiology and structural heart at the Providence Heart and Vascular Institute. According to LinkedIn, he spent eight years at Harvard Medical School and Massachusetts General Hospital.

Julie Tyler, Abbott SVP and president of the Vascular unit, welcomed Korngold in a LinkedIn post…

BioSig Technologies appoints new CEO

BioSig Technologies today announced it appointed Anthony Amato as CEO, effective immediately.

Amato will serve on the company’s board of directors, which is currently being assembled. He joins the company from consulting firm Bridge Associates International Pharmaceutical Consulting (BAIPC).

Westport, Connecticut-based BioSig Technologies announced earlier this month that the company engaged with BAIPC as a “natural progression” for the company to make “meaningful progress toward restoring and creating lasting shareholder value.” Amato led BAIPC.

“Approximately 2 months ago, I took the initiative to review, analyze, and address the urgent issues that had the potential to negatively impact the company’s future,” Amato said in a news release. “Since then, important and material progress has been realized on multiple fronts, and I have accepted this new position to accelerate the implementation of the comprehensive …

Senseonics wins integrated CGM designation from FDA, can work with insulin pumps

The Eversense E3 system. [Image from Ascensia/Senseonics]The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS).

With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future 510(k) submissions.

iCGM status indicates that Eversense can integrate with compatible medical devices. That includes insulin pumps as part of an automated insulin delivery system. Senseonics and Ascensia Diabetes Care, its distribution partner, plan to advance partnership discussions with pump manufacturers.

According to Senseonics, Eversense is “exceptionally well-suited” for automated insulin delivery systems.

Get the full story at our sister site, Drug Delivery Busines…