Medical Design and Outsourcing Archives - Page 115 of 154

A closer look at a microrobot that could treat a rare brain malformation

Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers.

The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation.

In 1914, neurosurgeon Walter Dandy observed a toddler with a brain cyst that led to swelling in the back of the brain. In the 1940s, another neurosurgeon, Arthur Earl Walker, identified the same type of malformation, later dubbed Dandy-Walker syndrome. While the syndrome varies in severity, children with the condition may have developmental and movement disorders, vomiting or seizures.

Treatment options for the syndrome have been limited to shunt surgery, which has a significant rate of complications. A 2015 study found more than one-quarter of Dandy-Walker syndrome patients experienced complications, including infection, shun…

A closer look at a microrobot that could treat a rare brain malformation

Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers.

The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation.

In 1914, neurosurgeon Walter Dandy observed a toddler with a brain cyst that led to swelling in the back of the brain. In the 1940s, another neurosurgeon, Arthur Earl Walker, identified the same type of malformation, later dubbed Dandy-Walker syndrome. While the syndrome varies in severity, children with the condition may have developmental and movement disorders, vomiting or seizures.

Treatment options for the syndrome have been limited to shunt surgery, which has a significant rate of complications. A 2015 study found more than one-quarter of Dandy-Walker syndrome patients experienced complications, including infection, shun…

Heraeus buys Mo-Sci and ETS Technology Holdings

Mo-Sci makes glass products for medical devices. [Photo courtesy of Mo-Sci]

The Heraeus Group has a deal to acquire Mo-Sci Corp. and ETS Technology Holdings, the Germany-based conglomerate announced this week.

Mo-Sci is a supplier of glass microspheres, fibers and powders for medical devices, while ETS is the developer of bioactive glass fiber wound care product Mirragen, an FDA-cleared resorbable synthetic skin substitute.

The companies — both in Rolla, Missouri — will join Hanau, Germany-based Heraeus Group’s healthcare and medical technology portfolio. The deal is anticipated to close by the end of 2021.

“Across every treatment area, medical technology is changing rapidly,” Heraeus Head of Business Area Medical Technologies Nicolas Guggenheim said in a news release. “The acquisition of Mo-Sci and ETS gives us new capabilities to help our customers deliver innovative technologies and break…

Medical Alley appoints new CEO

The Medical Alley Association announced today that it appointed Roberta Dressen as its new president & CEO.

Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then.

Get the full story at our sister site, MassDevice.

Westfall Technik names Mark Gomulka as CEO

Westfall Technik’s board of directors has promoted Mark Gomulka to CEO.

Gomulka joined the Las Vegas-based plastics manufacturer as SVP in January 2020. Before that, he led Flex’s medical and precision plastics operations for five years and earlier spent 15 years at Nypro in various global operational and leadership roles.

In those roles before joining Westfall, Gomulka worked closely with Westfall founder Brian Jones.

“I trust Mark to lead Westfall as CEO,” Jones said in a news release. “I’ve seen executives grow up in the plastics industry for a long time, and Mark knows better than anyone how to execute the integrated vision for Westfall. We’ve worked together closely for many years, and Mark has done a masterful job maturing the Westfall organization.”

The Westfall leadership team has launched or acquired 18 companies since October 2017, when New York-based private equity firms Lee Equity Partners and BlackBern Partners sponsored the Westfall …

The MedTech Conference by AdvaMed to be a mixture of in-person and virtual

To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week.

The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a news conference today:

Former U.S. Secretary of Defense Chuck Hagel will deliver an afternoon keynote on Monday, September 27, in Washington, D.C. CMS’s chief medical officer Dr. Lee Fleisher will discuss his work during a late morning talk on September 27. FDA’s Virtual CDRH Town Hall — a perennial favorite at the conference — will take place virtually on the evening of September 27. The in-person Minneapolis events September 29–30 include a who’s who of medtech CEOs, including Abiomed’s Michael R. Minogue (also the present AdvaMed board chair), Edwards Lifesciences’ Michael…

Varta launches online battery monitoring feature

Varta’s Cloud Monitoring Dashboard [Image courtesy of Varta]

Battery maker Varta has launched a cloud computing feature to let customers remotely monitor battery charging, health and the temperature of the battery management system.

While Varta makes microbatteries for medical devices such as hearing aids, the new online monitoring dashboard is meant for its “Easy Block” and “Easy Blade” modular smart batteries. The smart batteries go into forklifts, driverless transport systems and other small or medium vehicles at manufacturers and distributors. Users of Varta’s customer-specific batteries will also have access to the remote monitoring feature, and Varta said it plans to expand its cloud services in the future.

The rechargeable “Easy Block” and “Easy Blade” lithium batteries are modular and expandable. They’re adaptable for applications …

Bionaut Labs wins humanitarian use device designation to treat rare pediatric brain disorder

A Bionaut prototype. The final device may undergo alteration based on FDA feedback.

The microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat a Dandy-Walker syndrome, a congenital brain malformation affecting the cerebellum.

According to the National Organization for Rare Disorders, the syndrome affects one out of every 25,000 to 35,000 live births.

There are currently few treatment options for the condition. A surgically-placed cerebral shunt can relieve excess fluid in the brain to relieve intracranial pressure. As Los Angeles–based Bionaut notes, invasive procedures have a risk of infections and complications.

The company says BNL-201 offers a minimally invasive option to fenestrate (puncture) the cyst that forms at the back of the brain in Dandy-Walker syndrome.

In June, FDA granted orphan…

Integer plans $30 million innovation and manufacturing facility in Galway

Integer Holdings Corp. (NYSE: ITGR) plans to build a medical device innovation and manufacturing facility in the Parkmore East area of Galway, Ireland.

Plano, Texas-based Integer said the initial phase of the project will total 60,000 square feet and a $30 million investment over the coming years, with construction scheduled from 2022 to late 2023 and equipment investments continuing for another two or three years.

Integer said it has planning permission for another 87,000 square feet of expansion when needed.

The medical device outsource manufacturer cited increased demand for regional research, development and manufacturing capabilities as well as capacity for catheters and delivery systems. Integer already has an R&D center in Galway and counts the manufacturing facilities in Galway and New Ross, County Wexford, among its 15 global manufacturing sites.

The expansion is expected to add 100 to 200 new jobs in engineering, administration and m…

Accu-Tube appoints Matthew Haddle as CEO

Accu-Tube today announced that it has appointed Matthew Haddle as its new CEO.

Prior to joining the Englewood, Colorado-based company, Haddle was GM of industrial coating services and equipment at Praxair Surface Technology. He has also held senior management positions at Albany Engineered Composites and Accellent.

Get the full story on our sister site, Medical Tubing + Extrusion.

LightDeck picks GS Plastic Optics for COVID-19 test ramp up

The LightDeck COVID-19 total antibody test device [Photo courtesy of LightDeck Diagnostics]

LightDeck Diagnostics has selected GS Plastic Optics to make optical components for its new COVID-19 antibody testing platform.

Boulder, Colorado-based LightDeck developed a screening platform to deliver results as quickly as five minutes for SARS-CoV-2 ultra-rapid antigen and COVID-19 total antibody tests, using a laser waveguide with a consumable cartridge for each testing sample.

Rochester, New York-based GS Plastic Optics (GSPO) will be the lead source for that highly-engineered laser waveguide, requiring a $5 million expansion in Rochester for an 8,000-square-foot addition to the injection molding facility and additional presses, tooling and ancillary equipment.

Funds for the GSPO expansion will come out of a $35 million federal contract to expand LightDeck’s monthly test production capacity from 50,0…

Holigic’s first Global Women’s Health Index flags preventative care for improvement

[Photo courtesy of Hologic)

An estimated 1.5 billion women have not been tested in the past year for critical diseases, according to Hologic’s first Global Women’s Health Index.

On behalf of diagnostic maker Hologic, the Gallup World Poll surveyed more than 60,000 women and girls (age 15 and older) across the world to measure action and attitudes about women’s health, focusing on preventive care, opinions of health and safety, emotional health, individual health and basic needs.

Those five factors explain more than 80% of women’s average life expectancy at birth and are used in the Global Women’s Health Index to rank countries and territories, Hologic said in a news release. For example, heart disease is the leading cause of death globally, but only about one in three women are estimated to have had their blood pressure tested in the last 12 months.

“Preventive measures are a crucial first step to…