Irish researchers think their new material could enable better spinal cord repair

[Image from Alan Calvert on Unsplash]

Researchers at the University of Limerick in Ireland shared research demonstrating progress in spinal cord tissue repair.

The researchers, who conducted work at UL’s Bernal Institute, published their findings in Biomaterials Research.

According to a news release, they developed new hybrid biomaterials. They turned to nanoparticles built on existing practices in tissue engineering. As a result, they successfully synthesized the materials to promote repair and regeneration following spinal cord injury.

Maurice Collins, associate professor of the School of Engineering at UL led the team. So, too, did lead author Aleksandra Serafin, a PhD candidate at UL. Their research used a new kind of scaffolding material and a unique new electrically conducting polymer composite. This promoted new tissue growth and generation.

“Spinal Cord Injury remains one of the mos…

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What’s so special about Apollo Endosurgery’s stomach-shrinking weight loss tech?

The Apollo Endosurgery OverStitch Sx endoscopic suturing system [Image courtesy of Apollo Endosurgery]

Apollo Endosurgery — set to be purchased by Boston Scientific for $615 million — develops new devices and minimally invasive procedures for weight loss.

The procedure is called endoscopic sleeve gastroplasty (ESG) and the device that made it possible is the OverStitch endoscopic suturing system.

Austin, Texas-based Apollo Endosurgery first won 510(k) clearance for OverStitch in 2008, with successive clearances for improved designs over the years. Most recently, in July the FDA granted de novo clearance for Apollo Endosurgery’s Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems. They’re the first FDA-authorized devices for ESG and endoscopic bariatric revision procedures.

Medical Design & Outsourcing spoke with Apollo Endosurgery Chief Medical Officer Dr. Christo…

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4 tips for medical device companies that are choosing a quality management system

Ami Anderson is the director of operations and quality management at NeuFit. [Photo courtesy of NeuFit]

The right quality management system can be instrumental for success, but how can medical device companies adopt a comprehensive process and platform that meets their current and future needs?

Ami Anderson, NeuFit

Quality isn’t optional in the world of medical devices. Every item that makes its way into the hands — or the body — of a patient needs to be manufactured to the absolute highest standards with no deviation in uniformity or function.

Not only do devices have to work exactly as advertised, but companies must continually prove that they are completely on top of every part of their design, manufacturing and testing processes in a clear, complete and accessible way.

That’s why a proactive, fit-for-purpose quality management strategy isn’t optional, either. Working with the wrong electro…

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How Google and iCAD will partner to advance AI mammography

iCAD’s AI for digital breast tomosynthesis provides a case score for each detection. (Image courtesy of iCAD)

iCAD will help Google Health get its AI mammography technology into clinical practice, while Google will help iCAD improve its algorithms and reach more patients through the cloud.

Google and cancer detection developer iCAD are teaming up on the development and commercialization of artificial intelligence (AI) for detecting breast cancer.

It’s Google Health’s first partnership with a mammography AI provider. The development and commercialization agreement is Google Health’s first deal to introduce its breast imaging AI into clinical practice through iCAD’s portfolio of AI products.

RELATED: How the cloud tools behind Google Maps and Photos can advance medtech

Nashua, New Hampshire-based iCAD (Nasdaq:ICAD) is licensing Google’s AI technology for breas…

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New results detail J&J Embotrap design’s first-pass performance in stroke patients

A blood clot captured by the Embotrap stent retriever [Photo courtesy of Johnson & Johnson MedTech]

Johnson & Johnson (NYSE:JNJ) has released results for its Embotrap stent retrievers showing the next-generation design’s success in removing blood clots from ischemic stroke patients.

Johnson & Johnson MedTech’s Cerenovus subsidiary tracked outcomes for 1,000 ischemic stroke patients who underwent mechanical thrombectomy procedures with Embotrap devices as a first-line therapy.

“The positive preliminary findings of this research provide real-world results that demonstrate advances are possible in mechanical thrombectomy procedures to treat ischemic stroke,” Cerenovus Worldwide President Mark Dickinson said in a news release. “It is encouraging to see these positive results and realize the impact this data can have on improved patient outcomes and changing the trajectory of stroke.”<…

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Cardinal Health expands single-use device reprocessing facility

Cardinal Health’s Sustainable Technologies facility in Riverview, Florida [Photo courtesy of Cardinal Health]

Cardinal Health (NYSE:CAH) recently opened its expanded Sustainable Technologies facility in Riverview, Florida.

The facility is now twice as large as before, at 100,000 square feet, said Dublin, Ohio-based Cardinal Health.

The medical device manufacturer and distributor launched Sustainable Technologies in 2015 to collect, reprocess and recycle single-use devices in the U.S. Sustainable Technologies now works with more than 3,000 U.S. hospitals and ambulatory service centers, Cardinal Health said.

The FDA allows single-use devices to be used more than once if reprocessors can show the reprocessed devices are substantially equivalent to the original device. Many single-use devices can be recycled when they can not be reprocessed.

NEED TO KNOW: Ramping up manufacturing for sing…

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A new mechanically active adhesive fights muscle atrophy

Mechanically active gel-elastomer-nitinol tissue adhesive (MAGENTA) device prototypes made with a nitinol spring and elastomer insulation, with a penny for scale [Photo courtesy of the Wyss Institute at Harvard University]

Harvard bioengineers have created a mechanically active adhesive that can prevent muscle wasting and support atrophy recovery.

They call it MAGENTA, an acronym for mechanically active gel–elastomer–nitinol tissue adhesive. Researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A. Paulson School of Engineering and Applied Sciences successfully tested MAGENTA in an animal model and published their study in Nature Materials.

“With MAGENTA, we developed a new integrated multi-component system for the mechanostimulation of muscle that can be directly placed on muscle tissue to trigger key molecular pathways for growth,” senior au…

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November 2022 Issue: 2022 Medical Device Handbook


Medtronic, Abbott and ResMed see healthcare improving through ecosystems

DermaSensor aims to expand access to accurate skin cancer detection

How J&J’s Embotrap stent retriever thrombectomy treats ischemic strokes

Innovate together

Medical devices have never been more complex than they are today.

They’re getting smaller, smarter and safer. They’re more effective, intuitive and sustainable. Medical device companies manufacture some to last longer — and then redesign others for just a single sure-fire use.

Device developers have more options than ever: advanced materials, cutting-edge components and new technologies like 3D printing, artificial intelligence and robotics that lend a helping hand in the operating room and on the production line.

It’s also never been harder to go…

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Could minimally invasive neuromod tackle the opioid epidemic?

The Sparrow therapy system. [Image from Spark Biomedical]

Officials at Spark Biomedical and AcuityMD think their partnership could accelerate the commercialization of Spark’s potentially game-changing platform.

Spark Biomedical develops a topical, minimally invasive medical device for alleviating opioid withdrawal symptoms. AcuityMD has a platform for helping medical device companies accelerate commercial access to their products.

Together, they seek to provide a pathway to life-restoring sobriety for millions suffering from opioid addiction. Last month, Spark and AcuityMD announced a partnership to accelerate the expansion of the former’s technology. The FDA-approved Sparrow therapy system represents a drug-free tool for helping treat opioid use disorder. It sends mild electrical impulses to the brain to help alleviate withdrawal symptoms.

AcuityMD’s data-driven commercial platform suppo…

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BMP Medical appoints Michael Carignan as programs and engineering manager

[Image from BMP Medical]

BMP Medical announced that it appointed Michael Carignan as its new programs and engineering manager.

Carignan joins BMP Medical at its Sterling, Massachusetts plastic manufacturing hub facility. He brings with him more than 33 years of experience in the plastic manufacturing industry.

Before BMP Medical, Carignan served as president of Wachusett Precision Tool for more than five years before selling the company this year. He held senior engineering, program management, director of sales and business development roles at Nypro Healthcare (now Jabil) over 18 years.

“Michael Carignan brings a wealth of experience and knowledge to this important position, and has a successful background in the plastics industry,” said BMP Medical President and CEO Michael Faulkner. “His experience in growing businesses and delivering excellent customer experience …

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PTI Engineered Plastics receives MedAccred plastics accreditation

PTI Engineered Plastics recently announced that MedAccred has recognized it for its commitment to continual improvement in medical device quality.

The Macomb, Michigan–based company’s MedAccred accreditation follows a successful audit. MedAccred found that the medical device contract manufacturer demonstrated an ongoing commitment to quality by satisfying customer requirements and industry specifications.

The nonprofit Performance Review Institute administers the MedAccred program. Its EVP and COO Jay Solomond said MedAccred accreditation has global recognition as a hallmark of quality and is a major accomplishment.

“The medical device industry has incorporated MedAccred into its approach for handling risk, as it demonstrates compliance to industry standards and customer requirements. I am delighted, therefore, that PTI Engineered Plastics has achieved MedAccred accreditation for Plastics, and that all their hard work has paid off,” Sol…

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Millstone Medical Outsourcing buys MycoScience

Millstone Medical Outsourcing has purchased MycoScience, the companies said today.

Fall River, Massachusetts-based Millstone said it closed the deal on Nov. 14. Terms were not disclosed.

Willington, Connecticut-based MycoScience is an ISO 13485 certified contract manufacturing organization operating out of an FDA-registered facility. The company has more than three decades of experience in medical device and pharmaceutical laboratory testing, environmental testing and related regulatory support services.

“With the acquisition of MycoScience, we can offer our customers more support and better controls around product testing, with a single expert point of contact,” Millstone CEO Karl Neuberger said in a news release. “The more advanced and thorough post-manufacturing and aftermarket services we can offer our customers, the more we can support them in creating and accelerating products that change patients’ lives. This acquisition brings together two compan…

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