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Lucid Hearing launches new over-the-counter hearing aids

The Tala OTC hearing aids. [Image courtesy of Lucid Hearing]Lucid Hearing announced today that it launched its Tala over-the-counter (OTC) hearing aid product line.

Fort Worth, Texas-based Lucid Hearing designed Tala with Bluetooth-compatible wireless streaming. It also features patented LucidShape app-controlled, customizable profiles, a moisture-resistant coating and a rechargeable design. Its precision directional listening (PDL) system enhances the ability to hear speech and other sounds while minimizing background noise.

The Tala hearing aids combine sophisticated signal processing algorithms with directional power. It refines sounds originating from the direction the user faces while expressing unwanted noise from elsewhere.

“Tala is innovative, discreet and powerful and uses our most advanced technology released to date,” said Steve Iseberg, VP of innovation for Lucid Hearing. “This product’s discreet design will make it popul…

3M announces $6 billion earplugs settlement

3M (NYSE: MMM) + today announced that it will pay $6 billion in cash and stock for the rest of the decade to resolve hundreds of thousands of veterans lawsuits over faulty earplugs.

Bloomberg News and The Wall Street Journal previously reported that 3M was close to reaching a settlement. The agreement with negotiating plaintiffs’ attorneys has the manufacturing giant paying $5 billion in cash and $1 billion in stock between 2023 and 2029.

3M structured the agreement to promote participation by claimants and is intended to resolve all claims associated with subsidiary Aearo Technologies’ Combat Arms Earplug products. The agreement includes all claims in the multi-district litigation in Florida and in the coordinated state court action in Minnesota, as well as potential future claims. The Florida and Minnesota courts are entering orders to support the implementation of the agreement, according to 3M.

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Mapping the cancer patient journey with liquid biopsy

Pancreatic cancer cells with blue nuclei forming a sphere surrounded by red membranes in a lab setting. [Credit: National Cancer Institute]

According to the American Cancer Society, one in two men and one in three women will be diagnosed with cancer at some point in their lives. Patients seek treatment to shrink their tumors and ideally achieve remission; however, there is no one-size-fits-all approach. At its core, cancer is a genetic disease: Different types of cancer that affect specific organs or systems can share genetic qualities, but every individual can also carry unique mutations that affect how their tumor behaves. Therefore, molecular testing has a critical role to play in all stages of cancer treatment, from developing new drugs to delivering these as treatments.

The promise of molecular testing approaches

Over the years, increasingly complex molecular testing approaches have gained favor in the fie…

Implantable CGM maker Glucotrack names new VP of marketing

New Glucotrack VP of Marketing Drinda Benjamin. [Image from Drinda Benjamin on LinkedIn]Glucotrack (Nasdaq:GCTK) announced that it appointed Drinda Benjamin as its new vice president of marketing.

Rutherford, New Jersey-based Glucotrack develops an implantable continuous glucose monitor (CGM). It designed its CGM for patients with type 1 and type 2 insulin-dependent diabetes. A recent feasibility study demonstrated reliable glucose measurements for two years post-implant for the device.

Benjamin brings more than 20 years of experience in life sciences to Glucotrack, with focus on commercializing health technology. She has past experiences in product development, strategic marketing and more in the diabetes space. That includes work with blood glucose monitoring, CGM, insulin delivery and closed-loop systems.

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

Harmac Medical Products completes second plant in Tijuana

The new Harmac Medical Products facility in Tijuana, Mexico. [Image courtesy of Harmac Medical Products]

NEWS RELEASE: Harmac Medical Products announces completion of new manufacturing facility in Tijuana, Mexico

Harmac Medical Products, a global contract design and manufacturing organization (CDMO) for single-use medical devices, recently announced that it has built a second facility in Tijuana, Mexico. The new building will triple manufacturing space, expanding capacity and bolstering Harmac’s ability to provide full-service solutions in a near-shore location.

The new facility features 106,000 square feet of space, with a plan for 32,000 square feet of ISO 7 and ISO 8 cleanrooms, warehousing, engineering offices, quality management labs and other facilities to support Harmac’s growing operations. The building will house a full suite of integrated services, including design for…

Cellares teams up with Bristol Myers Squibb to explore automated CAR-T cell therapy manufacturing

Less than a week after announcing that it has secured $255 million in Series C funding, South San Francisco-based startup Cellares has revealed that Bristol Myers Squibb has joined its Technology Adoption Partnership (TAP) program. To date, the company has raised more than $355 million in total financing.

As part of the TAP program, Bristol Myers Squibb plans on conducting a proof-of-concept transfer of a CAR-T cell therapy process onto the Cell Shuttle, which the company has called a “factory in a box.”

Cellares plans to use the funding to launch what it dubs the world’s first commercial-scale Integrated Development and Manufacturing Organization (IDMO) smart factory. Koch Disruptive Technologies led the investment round, which included participation from Bristol Myers Squibb, DFJ Growth, Willett Advisors, Eclipse, Decheng Capital and 8VC.

When asked how Cellares managed to receive a large funding round in a difficult financial climate, Gerlinghausen sa…

Biotronik announces first U.S. implant of next-gen pacemaker

The Amvia and CRT-P pacemaker family. [Image from Biotronik]Biotronik today announced the first U.S. implantation of its new, next-generation Amvia Edge pacemaker system.

The FDA approved the Biotronik portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P) last month. Dr. Raul Weiss completed the procedure at Mount Sinai Medical Center in Miami, Florida.

“I was very pleased to have been a part of the first implant of Amvia Edge. The procedure went well, and I’m excited about the benefits this new device will be able to bring to our patients as well as our practice,” said Weiss. “The ability to eliminate device scans before and after an MRI procedure is a much-needed advancement, and I look forward to seeing how these types of technologies help streamline our workflows in the future.”

More about the Biotronik Amvia Edge pacemaker family

Lake Oswego, Oregon-based Biotronik designed Amvia Edge a…

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

PolyVascular, CobiCure partner on non-surgical pediatric heart valve

A non-surgical heart valve that could treat pediatric patients with heart disease. [Image from the PolyVascular website]CobiCure Medical Technologies announced that it provided $2 million in funding to PolyVascular to advance a pediatric heart valve.

Houston-based PolyVascular — a MedTech Innovator accelerator participant in 2020 — develops a first-of-its-kind heart valve. The potentially transformative, non-surgical valve could treat young children suffering from congenital heart disease.

New York-based CobiCure, a non-profit pediatric initiative, aims to provide strategic support and resources in addition to the funding. The initiative seeks to further advance the development of the novel polymer heart valve toward human clinical readiness.

According to a news release, the companies hope to accelerate potentially life-saving technology for children born with congenital heart defects.

“CobiCure’s mission, strategic ecosystem, and critica…

FDA clears new infusion pump and software from ICU Medical

The Plum Duo infusion pump with LifeShield infusion safety software. [Image courtesy of ICU Medical]ICU Medical (Nasdaq: ICUI) + announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software.

The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024.

Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on the cassette technology in the Plum 360 system. It features a large color touch screen with a highly intuitive user interface. With two channels, the system can deliver up to four compatible intravenous (IV) medications.

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

HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

Haemonetics brings vascular closure device to Europe

The Vascade MVP vascular closure device. [Image from Haemonetics]Haemonetics (NYSE:HAE) today announced the first patients treated with its Vascade MVP venous vascular closure system in Germany.

Boston-based Haemonetics said this marks the first use of the Vascade portfolio — widely used in the U.S. — in a European country.

The company designed Vascade for small-bore femoral arterial and venous closure. Its general uses include interventional cardiology and peripheral vascular procedures. Haemonetics developed Vascade MVP for mid-bore multi-access femoral venous closure, generally used in electrophysiology procedures.

Both closure devices hold CE mark approval in Europe. They cover patients who have undergone catheter-based procedures with single or multiple access sites in one or both limbs and include proprietary collapsible disc technology and a resorbable collagen patch to achieve hemostasis.

Haemonetics says its Vascade and Vascade MVP systems c…