Medical Design and Outsourcing Archives - Page 113 of 154

Medtronic’s Hugo robotic-assisted surgical system wins regulatory nod in Europe

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) announced that it received CE mark approval in Europe for its Hugo robotic-assisted surgery system.

Fridley, Minnesota-based Medtronic’s CE mark covers urologic and gynecologic procedures, which make up approximately half of all robotic procedures performed today, according to a news release.

Last month, the company said it had been expecting approval soon.

Get the full story at our sister site, MassDevice.

How Hologic made a major pandemic pivot

Hologic Chief Financial Officer Karleen Oberton [Photo courtesy of Hologic]

Hologic CFO Karleen Oberton reflects on key decisions and turning points of the COVID-19 pandemic.

Hologic’s fiscal year closes in September, but Chief Financial Officer Karleen Oberton had seen enough by late July to call it: 2021 would be the best financial year ever.

Oberton and the women’s-health-focused company have come a long way since sketching out doomsday scenarios in March 2020.

“We quickly went from counting every penny to these exponential sales on the COVID testing,” Oberton said in an interview with Medical Design & Outsourcing.

She shared the company’s path through the pandemic, ramping up its diagnostics business to support and grow its surgical and breast health lines for the post-pandemic future.

“While already a strong leader, Karleen became an even str…

Insulet CEO Shacey Petrovic touts Omnipod 5, expects device launch this year

The Insulet Omnipod 5 [Photo courtesy of Insulet]

With FDA clearance imminent, Petrovic says Insulet’s latest device offers real change in diabetes care.

Faced with either a bulky insulin pump or delivering multiple daily injections, Boston-based entrepreneur and venture capitalist John Brooks III sought an easier way to treat his young son’s newly diagnosed type 1 diabetes.

He assembled a team of engineers and they created Omnipod, Insulet’s (NSDQ:PODD) wearable, automated insulin delivery patch system.

“The company was founded in 2000 based on that innovation and ingenuity and that sort of spirit stays with the company,” CEO Shacey Petrovic said in an interview with MassDevice. “We’re continuing to invest in innovation and look for a better way. The origin story was born of patient need and that is at the core of our mission.”

Get …

6 startup trends from Deloitte and MedTech Innovator — and warnings for established medical device companies

The medical device industry is shifting, and startups and established medical device companies alike should prepare for key trends identified in a new report from Deloitte.

Deloitte’s Center for Health Solutions and MedTech Innovator worked together to analyze MTI’s database of approximately 1,000 applicants for MTI’s 2021 startup accelerator program.

The startups that applied had at least developed a prototype, but had not yet progressed beyond a series D round of funding. They come from 48 states in the U.S. and 43 countries.

Alva Health was named as the competition’s winner last week, but they’re not the only promising company. Of this year’s applicants, about three-quarters have raised equity funding, totaling a collective $3.9 billion. More than one-fifth of the applicants already have customers, and 9 percent have won regulatory approval.

As part of its analysis, Deloitte interviewed leaders from startups and medtech companies that could be …

Tekni-Plex Healthcare buys precision extrusion manufacturer Johnson Plastic Group

Tekni-Plex Healthcare announced today that it acquired precision extrusion manufacturer Johnson Plastic Group.

Wayne, Pennsylvania-based Tekni-Plex said in a news release that the acquisition — for which financial terms were not disclosed — constitutes part of its strategy to expand the company’s patient care solutions platform.

Get the full story at our sister site, Medical Tubing & Extrusion.

BREAKING: Medtronic expands Class I recall of MiniMed 600 series insulin pumps

Medtronic’s MiniMed 630G insulin pump [Image courtesy of Medtronic]

The FDA today announced that Medtronic (NYSE:MDT) has expanded the Class I recall of its MiniMed 600 series insulin pumps.

Medtronic today notified customers by email and phone that the recall has been expanded to replace all MiniMed 600 series insulin pumps that contain the clear container ring.

The Fridley, Minnesota-based company first warned of safety problems with the pumps in November 2019. The recall initially involved 322,005 pumps — MiniMed 630G and MiniMed 670G — in the U.S.

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

Abbott CEO Robert Ford to keynote at CES 2022

The Consumer Technology Association (CTA) announced today that Abbott president & CEO Robert B. Ford will deliver a keynote at CES 2022.

Ford’s keynote represents the first time in CES history that a healthcare company will deliver a keynote at the major technology event, according to a news release. Ford will be joined by a group of Abbott scientists, engineers, investors and partners to discuss technology in healthcare and the empowerment of people to engage in their own health.

“Technology improves lives, and now more than ever, we are witnessing technology’s incredible impact on healthcare, allowing us to take better control of our health,” CTA president & CEO Gary Shapiro said in the release. “We’ve seen a rapid shift in healthcare innovation, with technology leading the charge to bring quality healthcare to all global citizens. We are thrilled to welcome Robert to the CES keynote stage to share more about Abbott’s vision for the future of he…

Carl Stahl Sava Industries wins New Jersey Manufacturer of the Year award

Carl Stahl Sava Industries at NJMEP 2021 [Photo courtesy of Carl Stahl Sava Industries]

Cable manufacturer Carl Stahl Sava Industries has won a Manufacturer of the Year award from the New Jersey Manufacturer’s Extension Program (NJMEP).

The “Manufacturing Cares” category award recognizes New Jersey manufacturers for their commitment to industry leadership, innovation, growth through revenue and the growth and development of employees and communities in the areas of operations and continuous improvements, management philosophy, workforce development and supply chain development. The award is named after the NJMEP Manufacturing Cares philanthropic program,

Headquartered in Riverdale, New Jersey, Sava is a manufacturer of custom, miniature and ultrafine tungsten, stainless steel and other mechanical cables, assemblies and components for the wearable and surgical robotics markets, as well industr…

FDA issues final rule to make de novo classificaiton process easier

The FDA yesterday issued a final rule aimed at simplifying the de novo classification process for medical devices.

In publishing the final rule, the FDA established procedures and criteria for submitting and withdrawing a de novo request, while also setting guidelines for the FDA to accept, review, grant and/or decline such a request for a process that allows some medical devices to leapfrog the premarket approval process.

FDA said that, while several comments object to sections or subsections of the proposed rule, almost all comments voice support for the objective of the proposed rule aimed at establishing regulations for the process.

Among the criteria in the rule is the stipulation that a person may submit a de novo request after submitting a 510(k) application and receiving a not substantially equivalent (NSE) determination. Additionally, a person may submit a de novo request without first submitting a 510(k), provided that there is no legally marke…

Raumedic plans U.S. headquarters expansion

Raumedic’s U.S. headquarters in Mills River, North Carolina [Photo courtesy of Raumedic]

Raumedic today said it intends to expand the clean room manufacturing facilities at its U.S. headquarters in Mills River, North Carolina.

The new clean room is expected to be completed by February 2022 and used for new product lines. The Helmbrechts, Germany-based medical device component developer and manufacturer built its existing 13,000-square-foot clean room production facility in 2016.

“Growth is the key word for describing our five years in Mills River,” Raumedic President and CEO Martin Bayer said in a news release.

“The advanced equipment and processes that will go into the new space will help us to remain ahead of the curve,” he said. “With automated assembly cells and robotically augmented molding presses, we are able to produce high-quality medical technology solutions in the main…

NIH funds Annoviant heart implant materials tech that can grow with children

[Image from Annoviant’s website]

Annoviant announced today that it received a $1.85 million NIH grant to help further the development and commercialization of its TxGuard.

Atlanta-based Annoviant’s latest grant for the TxGuard pulmonary-valved conduit represents a continuation of the Phase I Small Business Technology Transfer (STTR) grant the company received in 2019, according to a news release.

The conduit, tailored largely toward pediatric patients, offers an option for treating congenital heart disease (CHD) designed to resist early degeneration while allowing regeneration with host cells, enabling the device to grow with children.

Annoviant’s TxGuard “scaffolding” offers clinical advantages over commercial products, the company says. It includes what the company touts as cutting-edge qualities making it resistant to calcification, thrombosis and infection and can…

BICO plans to acquire QInstruments for its bioautomation business

Erik Gatenholm is the CEO of BICO Group. [Photo courtesy of BICO]

BICO Group has a deal to acquire QInstruments for $71 million, the life sciences holding company said Friday.

Headquartered in Jena, Germany, QInstruments was founded by CEO Olaf Simmat and Christian Stange in 2003. It’s a developer, manufacturer and supplier of advanced sample preparation automation for clinical diagnostics and biomedical and life science research.

BICO plans to close the deal “as soon as reasonably possible,” according to a news release. QInstruments will operate as a standalone company in BICO’s bioautomation business area to strengthen BICO’s ability to improve workflows for its other subsidiaries and customers.

“Our team invents user-friendly and intuitive systems that enable multidisciplinary research in a cost and time efficient manner,” Simmat said in the news release. “With BICO, we share a common vision o…