Medical Design and Outsourcing Archives - Page 43 of 154

MDR transition delay approved by European Parliament and Council

EU Commissioner for Health and Food Safety Stella Kyriakides [Photo courtesy of the European Commission]

The European Parliament and Council today voted to approve a Medical Devices Regulation (MDR) transition delay in an effort to avoid shortages.

The move gives medical device manufacturers more time to certify their devices under the new MDR rules.

“I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food Safety Stella Kyriakides said. “This will help give clarity to manufacturers and ensure that patients can access the essential medical devices they need. This is our top priority.”

The delay does not modify MDR’s current safety and performance requirements. Instead, it gives manufacturers more time to move from the old rules to the new requirements.

It al…

Baxter caps cash severance payouts for executives

Baxter International has prohibited cash severance payments that exceed three times the total of an executive’s salary and target annual bonus opportunity without shareholder approval.

The company disclosed the new policy as it restructures the business and cuts staff while looking to rebound from a multibillion-dollar net loss for 2022.

Deerfield, Illinois-based Baxter is the world’s 10th largest medical device company, according to the Medtech Big 100 list.

That ranking was based on Baxter’s $12.78 billion in revenue for 2021; the company last week reported 2022 sales of $15.1 billion and a full-year loss of $2.4 billion. That loss was primarily due to a $3.1 billion charge related to Baxter’s purchase of Hillrom.

Baxter announced the executive severance policy yesterday while naming presidents for its vertically integrated global business units. The company last week announced layoffs as it restructures the busin…

Boston Children’s to conduct FDA-approved studies of heart valve that grows as children do

Studies have shown the Autus Valve maintains control of blood flow as it expands. [Image courtesy of Boston Children’s Hospital]

Boston Children’s Hospital says it began conducting FDA-approved early clinical studies of its heart valve that expands over time.

In 2020, the hospital published research on its innovative heart valve design. It could allow children to maintain the same prosthetic heart valve until adulthood. This could also benefit adults with heart valve defects. The hospital calls it the “Autus Valve.”

Boston Children’s developed the valve because children with congenital heart disease receive fixed-size valves. These require multiple open-heart surgeries during childhood to replace valves with larger versions. Early simulations and animal tasting demonstrated successes through a range of sizes. They also showed retained functionality when expanded by a minimally inv…

Ranked: The biggest healthcare VC deals of 2022

A company that sends medical teams on house calls had one of the largest venture capital deals of 2022. [Photo courtesy of Dispatch Health]

The $3 billion launch of a biotech focused on cellular rejuvenation was 2022’s largest healthcare venture capital deal in the U.S. and Europe.

That’s according to a ranking provided to Medical Design & Outsourcing by Silicon Valley Bank (SVB), which ranked the deals using its own proprietary information and data from Pitchbook.

The biopharma sector represented three of the 10 largest VC deals. Diagnostics/tools had two deals on the list, taking the No. 2 and 3 spots. The healthtech sector had four deals on the list.

Only one device developer ranked in 2022’s top 10, just like the year before, when CMR Surgical’s $600 million Series D financing round was the fifth-largest deal of 2021. (Healthtech deals dominated the prior-year list by tak…

Asensus Surgical to collaborate with Google Cloud on machine learning for surgical robots

The Intelligent Surgical Unit powers the Senhance surgical robot system. [Image courtesy of Asensus Surgical]

Asensus Surgical (NYSE:ASXC) announced today that it entered into a multi-year collaboration with Google Cloud.

The collaboration integrates Google Cloud’s secure cloud data architecture and machine learning into the Asensus surgical robot platform. It further expands the capabilities of Asensus’ performance-guided surgery framework through its Intelligent Surgical Unit (ISU).

Research Triangle Park, North Carolina–based Asensus designed its performance-guided surgery to enhance accuracy and efficiency. The company says its platform can help surgeons avoid complications and improve patient outcomes.

Get the full story at our sister site, MassDevice.

Evonik enters agreement to produce silk proteins for AMSilk

Evonik announced today that it entered into an agreement with AMSilk to produce sustainable silk proteins.

AMSilk, a Germany-based biotech company, develops innovative, sustainable silk proteins. The uses of the silk include a broad range of applications including medical devices. They provide optimal performance and minimal environmental impact, according to a news release.

Essen, Germany-based Evonik’s agreement covers the production of industrial quantities of the silk proteins. Evonik plans to produce the silk at its contract development and manufacturing (CDMO) precision fermentation site in Slovakia.

“Working with a partner who puts sustainability at the heart of their business is in perfect alignment with our goals at Evonik. We are delighted to partner with AMSilk to bring smart biotech silk materials to industries worldwide,” said Thomas Riermeier, head of the Health Care business line at Evonik.

AMSilk turns man-made proteins into …

Researchers say ingestible sensor could help with diagnosing GI disorders

MIT engineers demonstrated that they can use magnetic fields to track the location of this ingestible sensor within the GI tract. [Image courtesy of the researchers]

Engineers at MIT and Caltech have developed an ingestible sensor that could more easily diagnose gastrointestinal motility disorders.

This advance could help with the diagnosis of constipation, gastroesophageal reflux disease and gastroparesis.

The engineers designed their tiny sensor to detect a magnetic field produced by an electromagnetic coil located outside of the patient’s body. The strength of the field varies with distance from the coil, which allows for the calculation of the sensor’s position based on its measurement of the magnetic field.

In a new study, the researchers demonstrated the ability to track the sensor as it moved through the digestive tract of large animals. They believe this could offer an alternat…

Decode deaths with BERT to improve medical device safety and design

Michelle Wu is the founder and CEO of Nyquist Data. [Photo courtesy of Nyquist Data]

By Qiang Kou and Michelle Wu, Nyquist Data

A recent study shows that the number of death events in the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database has been vastly underestimated because many are not reported as deaths.

Lalani et al. manually reviewed 290,141 MAUDE reports and found that around 17% of the death events had been misclassified. That means the patient died, but the event was labeled as having “no consequences or impact to patient.”

The manual review requires expertise in different medical specialties and is too time-consuming to process millions of added reports. This problem can be viewed as a binary classification problem. And we can fine-tune the BERT model to solve it.

What is BERT?

BERT stands for Bidirectional Encoder Representations from Transformers. Rec…

The Internet of Medical Things at the Heart of Digital Healthcare

Healthcare providers are experiencing a confluence of factors that are putting unprecedented strain on our medical infrastructure. An increase in acutely ill patients coupled with rising costs of providing adequate care are cause for concern. But connectivity and AI is driving digital transformation in clinical medical environments and giving rise to an internet of medical things that bring efficiency while increasing access and improving health outcomes.

In this report, Omdia analysts explore some of the technology trends and developments behind emerging medical IoT devices that can equip providers with insight to navigate these challenges.

Download this white paper…

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How digital tools can attract, engage and retain tech-savvy talent in medtech manufacturing

Photo courtesy of MasterControl

By Katie Farley, MasterControl

As digital initiatives in medical device and diagnostic manufacturing continue to advance, medtech companies face a significant technology talent shortage that is expected to get more severe as technologies and their associated skills become more advanced. What’s becoming clear is that attracting and retaining top talent is increasingly difficult in manufacturing environments dominated by paper.

On average, 45% of frontline manufacturing workers across all age groups say the opportunity to work in a more modern, digital environment would be part of their decision to leave their current employer, according to research from workforce software developer Parsable.

Digital technology is an expectation of today’s workers, who are familiar and comfortable with personal technologies like smartphones and tablets and immediate access to digi…

Covestro polycarbonate combines form and functionality for device that treats excessive sweating

NEWS RELEASE: Covestro polycarbonate combines form, functionality for Dermadry device that treats excessive sweating

Shown above is the Dermadry case, which also doubles as the treatment trays for hands and feet. The trays are molded with Makrolon® 2458 polycarbonate, which is proven for use in medical devices. [Photo courtesy of Covestro]

Hyperhidrosis, characterized by excessive sweating, affects approximately 1 in 20 people worldwide. Dermadry selects Makrolon® 2458 polycarbonate from Covestro for key components of the latest device for treating hyperhidrosis. Makrolon® 2458 material offers multiple benefits, including impact resistance, biocompatibility, quality and aesthetics.

Hyperhidrosis, a medical condition characterized by excessive sweating, affects the quality of life of approximately 1 in 20 people worldwide. Dermadry Laboratories lnc., a leading manufacturer of iontophoresis machines for at-home tre…

29 cutting-edge medtech innovations recognized with Edison Awards

More than two dozen medical technology developers are winners of the 2023 Edison Awards.

The 29 medtech winners include products from Boston Scientific, Shockwave Medical, Thermo Fisher, DermaSensor and Endiatx. They span four categories: engineering and robotics; health, medical and biotech; manufacturing and logistics; and personal technology and gadgets. Subcategories include smart wearables, noninvasive medtech, advanced drug delivery, AI-assisted medicine, operating room integration and more.

The winners are all finalists for gold, silver and bronze awards. Those awards will be revealed at the Edison Awards Gala on April 20, 2023, in Fort Myers, Florida.

Endiatx co-founder and CEO Torrey Smith with PillBot [Photo by Hardy Wilson for MDO]

Special honors went to Endiatx, which stands by itself as a “game changer” among the approximately 150 Edison Awards winners. Medical Design &…