News and Resources from the WTWH Media Life Science Network - Page 2 of 977

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 …

Former ZimVie exec Rebecca Whitney named CEO of Highridge Medical

Highridge Medical this week announced it appointed Rebecca Whitney as CEO, effective immediately.

Whitney will join the company’s board of directors as part of the appointment. Former CEO Glen Kashuba will transition to CEO of EBI.

Highridge Medical and EBI are portfolio companies of HIG Capital, which earlier this month acquired ZimVie’s spine and EBI Bone Healing businesses. Upon completing the acquisition, former ZimVie Global Spine President Whitney was slated to continue as president of the spine business at Highridge Medical.

“I am excited that Rebecca will now take the helm as CEO of Highridge. Her proven leadership, vision, and unwavering commitment to excellence are the driving forces that will propel Highridge into a promising future,” Highridge Executive Chair Eric Major said in a LinkedIn post. “I am confident that Rebecca will champion innovation and growth.”

Highridge Medical designs and commercial…

Hologic to acquire Endomagnetics in $310M deal

Hologic (NYSE: HOLX) + is set to acquire breast surgical guidance company Endomagnetics for $310 million.

Endomag develops and sells breast surgery localization and lymphatic tracing technology. It makes products like the Magseed marker for magnetic tissue localization before surgery. It also develops the Magtrace lymphatic tracing injectable for breast cancer staging and the Sentimag platform that supports localization and lymphatic tracing.

“Endomag’s suite of solutions complements our existing breast surgery portfolio and will provide surgeons and radiologists with an expanded range of options to meet the individual needs of more patients undergoing critical breast cancer procedures,” Hologic President of Breast and Skeletal Health Solutions Erik Anderson said in a news release. “With a global footprint and a similar commitment to women’s health, we are excited about the potential of welcoming the Endomag team and o…

Cobalt Polymers partners with HnG Medical for tubing distribution

NEWS RELEASE: Cobalt Polymers Announces Partnership with HnG Medical

Distribution agreement to expand customer access to heat shrink tubing in Asia

HEALDSBURG, Calif. —Cobalt Polymers, a leading manufacturer of heat shrink tubing for the medical device industry, recently announced an exclusive, multi-year agreement with HnG Medical Inc. to distribute its tubing products in Asia. The agreement will allow Cobalt to better serve its OEM customers in Asia with local representation and local access to tubing samples and inventory.

HnG Medical represents U.S. and European component suppliers and equipment manufacturers to many top-tier medical device manufacturers in Asian markets, leveraging local languages and market understanding to provide marketing, sales, customer service and technical support. HnG will represent Cobalt Polymers in China, Malaysia, Singapore, South Korea, Taiwan, Thailand and Vietnam.

“This partnership is a natural next step i…