- Medical Design Sourcing

Blue Goat Cyber

Navigating the intricate pathway to FDA approval for medical devices demands a vigilant eye on cybersecurity. At Blue Goat Cyber, we specialize in fortifying medical devices against the digital era's evolving cyber threats, ensuring your innovations meet FDA standards from concept to post-market. Our focus on medical device cybersecurity positions us as the ideal partner for manufacturers steering through the FDA approval process.

Blue Goat Cyber: Pioneering Cybersecurity for Medical Device Approval:

Founded by cybersecurity visionary Christian Espinosa, Blue Goat Cyber merges specialized cybersecurity expertise with a deep understanding of the FDA approval process. Our team is equipped with elite certifications and extensive cybersecurity experience, particularly in the medical device sector. This unique blend of skills enables us to provide tailored cybersecurity solutions that align with FDA regulatory requirements, ensuring a smoother approval journey for y…

View Listing

How much does a clinical research associate impact a company’s carbon footprint? More than you might think!

[Adobe Stock]

On March 6, 2024, the U.S. Securities and Exchange Commission approved a rule to require some companies to report some of their carbon emissions (Scope 1 and 2, but not Scope 3). While some feel this rule doesn’t go far enough, it certainly demonstrates the need to better understand our respective carbon footprints and develop solutions to reduce our environmental impact. Many major biopharmaceutical companies have science-based, net-zero targets set for no later than 2050. As this is decades away, one might think action today is not urgent. This is not the case. Consider a thought experiment for Fictitious Pharmaceutical Company (FPC) and its carbon footprint. Draw a straight line (real glide paths are not a simple linear expression) from where FPC is in 2024 to net zero by 2050 (see Figure 1). This will allow FPC to align with the Paris Agreement and science-based targets generally (see Figure 1). Or mo…

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 …

Inside BioXcel Therapeutics’ AI-driven drug reinnovation strategy

[Adobe Stock]

Friso Postma, vice president of AI for drug discovery at BioXcel Therapeutics, prefers the term “augmented intelligence” to “artificial intelligence.” His company uses AI tools to support human experts in drug repurposing efforts.

Postma, who holds a Ph.D. in signal transduction from the Netherlands Cancer Institute, transitioned to AI from wearable digital health devices. “I quickly found out that it’s very important to be able to contextualize AI,” he explains.

Now, Postma, trained as a biologist and electrophysiologist, that experience in contextualizing AI has been instrumental in developing and continuously refining an end-to-end platform for drug re-innovation, focusing on neurological rare and psychiatric disorders. This platform, which he helped create, is now central to his ongoing work. “Interestingly, I’m not a data scientist or an AI engineer, …

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…

The Critical Role of Partnerships in Medical Device Development

Key considerations for OEMs in medical device design and manufacturing.

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 …

‘Miniature is big’: How Virtual Incision designed the small but mighty MIRA surgical robot — and then shrank it again for space

The Virtual Incision MIRA Surgical System’s design was small to start with — and then came an opportunity to test aboard the International Space Station.

Virtual Incision’s MIRA (Miniaturized In Vivo Robotic Assistant) Surgical System [Photo courtesy of Virtual Incision]

In conversations with Medical Design & Outsourcing, surgical robotics developers often say they try to use as many off-the-shelf components as possible.

That wasn’t possible for the MIRA (Miniaturized In Vivo Robotic Assistant) Surgical System, Virtual Incision co-founder and Chief Technology Officer Shane Farritor said.

“Everything in our device is quite custom … from scratch, bespoke,” he said in an interview. “… Our robot’s different than everyone else, because it’s miniature, and we think miniature is big.”

Virtual Incision’s MIRA won FDA de novo class…

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…

Medtronic plans job cuts in California

Medtronic (NYSE:MDT) + is eliminating 44 jobs in Carslbad, California, according to a mass layoff notice filed with the state.

The permanent job cuts take effect starting on or around May 19 at 2101 Faraday Ave., Medtronic told the California Employment Development Department.

FDA records list that address as a facility for Nellcor Puritan Bennett Corp., a respiratory monitoring and ventilator brand that Medtronic acquired when it purchased Covidien.

In 2022, Medtronic said it wanted to spin off the Medical Surgical portfolio’s Patient Monitoring and Respiratory Interventions businesses, but no buyers emerged.

Instead, Medtronic said earlier this year that it planned to exit the ventilator market, saying the move would eliminate up to 40 jobs in Ireland. At the same time, Medtronic said Bob White, an EVP and president of the Medical Surgical portfolio, was leaving the company in a new round of reorg…

LivaNova names former J&J MedTech exec as chief innovation officer

LivaNova (Nasdaq: LIVN) + today announced it appointed Ahmet Tezel as chief innovation officer, effective May 13, 2024.

Ahmet Tezel, LivaNova chief innovation officer [Image courtesy of LinkedIn]Tezel will take on the newly created chief innovation officer position to establish an integrated innovation function at the company and accelerate the development of new technologies.

“I am very pleased to welcome Ahmet to the LivaNova team. At LivaNova, our commitment to pioneering innovation remains unwavering, and Ahmet’s arrival marks a significant step in advancing this vision. With a remarkable track record, Ahmet has led teams that have developed market-leading technologies across diverse medical domains, from bariatric surgery to surgical ophthalmology. As Chief Innovation Officer, Ahmet will advance LivaNova’s ability to create novel solutions and elevate the quality of care in neurological and cardiac…

Medline enters deal to acquire Ecolab’s global surgical solutions business

Medline today announced it entered into a definitive agreement to acquire Ecolab’s global surgical solutions business.

Upon closure of the deal, the acquisition will give Medline access to Ecolab’s Microtek product lines, sterile drape solutions for surgeons, patients and operating room equipment and Ecolab’s fluid temperature management system.

The company said it wants to “build on the deep legacy” of the Microtek brand by combining the reputation for innovation and reliability in these categories using Medline’s commercial footprint, market-leading supply chain capabilities and manufacturing expertise.

“We are pleased to have the opportunity to acquire a leading portfolio of operating room products with such a strong reputation for protecting patients and healthcare workers,” Medline President and Chief Operating Officer Jim Pigott said in a news release. “With our commercial capability and focus on operational exce…

Axogen announces first surgical implant of Avive+ Soft Tissue Matrix

Axogen (Nasdaq:AXGN) this week announced the first surgical implantation of its Avive+ Soft Tissue Matrix.

Avive+ is a resorbable, multi-layer, placenta-based allograft that provides temporary protection and tissue separation during the critical phase of nerve healing. The soft tissue matrix is processed and distributed as a 361 tissue product in accordance with FDA Good Tissue Practices under 21 CFR part 1271 regulations.

“We are excited to expand our offering in nerve protection with the introduction of this resorbable barrier to support the critical phases of healing for nerve injuries,” CEO and President Karen Zaderej said in a news release. “We are pleased with initial surgeon feedback and look forward to making Avive+ Soft Tissue Matrix available to more surgeons during our national launch, which is anticipated in the second quarter of 2024.”

Axogen’s nerve protection category covers a wide range of injuries and defects, according to the comp…

FDA clears Route 92 Medical’s FreeClimb 54 reperfusion system

Route 92 Medical today announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system.

The FreeClimb54 system uses an aspiration catheter of the same name paired with a Tenzing 5 delivery catheter. The new system is part of the company’s growing portfolio of neurovascular devices designed to work as complete endovascular thrombectomy solutions for neurovascular interventions.

“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximize their opportunity to restore blood flow to the brain on their first attempt,” CEO Tony Chou said. “The FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”

Route 92 Medical’s FreeClimb 54 system can telescope through the company’s complementary products to allow physicians to rapidly and predictably reach and remove …

View More Articles

Featured Listings

Latest Listings

MedTech News