Medical Design and Outsourcing Archives - Page 26 of 154

MIT researchers build wearable ultrasound scanner for earlier breast cancer detection

This wearable ultrasound scanner could offer frequent, at-home imaging of breast tissue to spot tumors earlier and increase survival rates. [Photo courtesy of MIT]

A wearable ultrasound scanner developed by researchers at MIT could improve the survival rate of breast cancer patients.

The researchers 3D-printed a flexible patch that can attach to a bra using magnets. The patch has six openings where a miniaturized ultrasound scanner can contact the skin and image the wearer’s breast tissue from different angles.

The goal is to detect breast cancer earlier with more frequent screening for patients at high risk.

“We changed the form factor of the ultrasound technology so that it can be used in your home,” MIT Media Lab Associate Professor Canan Dagdeviren, who designed the miniaturized scanner, said in a news release. “It’s portable and easy to use, and provides real-time, user-frie…

Alarming results and some good news from MDR and IVDR survey of notified bodies

[Image via Adobe Stock]

By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

Robotic hand uses low-cost touch sensors instead of vision

The four-fingered robotic hand has 16 touch sensors. [Image via UCSD]

Engineers at the University of California San Diego developed a new approach allowing a robotic hand to rotate objects solely through touch.

The UCSD method enables a robotic hand to do so without relying on vision. Using their technique, the engineers built a hand that can smoothly rotate a range of objects, including small toys and cans. It can rotate fruits and vegetables without squishing them as well, accomplishing its tasks using only information based on touch.

According to UCSD, the team believes the work could help develop robots that can manipulate objects in the dark.

To build the system, the team attached 16 touch sensors (which cost about $12 apiece) to the palm and fingers of a four-fingered robotic hand. These sensors detect whether an object is touching the robotic hand. The low-cost, low-resolution touch sensors…

Boston Scientific ramps up Farapulse manufacturing with new site

The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]

Boston Scientific plans to increase production of its Farapulse pulsed-field ablation (PFA) system with a second pulse generator manufacturing site.

“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.

He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”

Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).

Farapulse Inc. secured CE mark approval for the system before being acquired by Boston Sci…

Eagle Stainless Tube & Fabrication renews ISO 13485 and 9001 quality certifications

NEWS RELEASE: Eagle Stainless Tube & Fabrication Inc. proudly renews ISO 13485 and ISO 9001 quality management certifications, reaffirming its unwavering dedication to Quality and Compliance

Franklin MA, July 2023 – Eagle Stainless Tube & Fabrication, a leading small diameter stainless steel tubing supplier, is proud to announce the successful renewal of its ISO 13485:2016 and ISO 9001:2015 quality management certifications. Eagle has been maintaining ISO quality certifications since 1998, spanning 25 years! This achievement reflects the company’s unwavering commitment to maintaining the highest standards in quality management systems for medical devices and related services.

ISO 13485 and ISO 9001 are internationally recognized standards that set requirements for the development, production and distribution of medical devices. By adhering to this rigorous specification, Eagle Stainless ensures that its products and services consistently meet our customer’s …

Major device manufacturers face new rules on cyberattacks

Publicly traded medical device manufacturers such as Medtronic, Johnson & Johnson, Abbott and Stryker will need to publicly disclose significant cyberattacks under new rules approved by the Securities and Exchange Commission.

The SEC rules require all publicly traded companies — not just device makers — in the U.S. to release details of a cyberattack within four days of determining that it has a material impact. That determination comes down to whether “there is a substantial likelihood that a reasonable person would consider it important,” the SEC has said.

Related: The Medtech Big 100 ranks the world’s largest medical device companies

“Whether a company loses a factory in a fire — or millions of files in a cybersecurity incident — it may be material to investors,” SEC Chair Gary Gensler said in a statement. “Currently, many public companies provide cybersecurity disclosure to investors. I think companies and investors alike, howe…

FDA issues draft guidance on opioid-use disorder devices

The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.

The agency cited the specific challenges of designing clinical studies to evaluate these devices, including inaccurate self-reporting of drug use, missing data, the confounding effects of related drug treatments and the lengthy observation periods needed to demonstrate therapeutic.durability.

For example, the FDA said pivotal device studies to support marketing submissions “should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans.”

Related: Could minimally invasive neuromod tackle the opioid epidemic?

The FDA wants feedback on the draft guidance to review before finalization. The agency said the guidance doesn’t apply to diagnostics for opioid use or opioid use disorder, combination products, o…

TE Connectivity posts mixed Q3 results as medical market recovery continues

Medtech supplier TE Connectivity (NYSE: TEL) today released financial results for its fiscal Q3, falling short of analysts’ sales expectations but exceeding expected earnings.

Schaffhausen, Switzerland-based TE Connectivity said medical market performance in its industrial segment continues to improve. The company provides connectivity and sensor solutions for medical applications and a broad range of other industries.

“We delivered earnings above guidance, along with year-over-year sales growth in our Transportation and Industrial segments, as we continue to benefit from the strategic positioning of our portfolio around key growth and sustainability trends,” TE Connectivity CEO Terrence Curtin said in a news release. “Our leading global position in electric vehicles once again allowed us to deliver a strong performance in Transportation, and we continued to capitalize on growth momentum in renewable energy applications as well as ongoing market rec…

4 tips for sensor miniaturization from Lura Health

This rendering shows Lura Health’s saliva sensor in a retainer [Image courtesy of Lura Health]

Being in China when COVID-19 hit might not seem like a stroke of good luck, but it paid off for Lura Health’s sensor miniaturization efforts.

Without a physical presence in Shenzhen, the minature sensor startup might not have been able to line up a battery supplier willing to take on the demanding needs of Lura Health’s saliva sensor, said co-founder and CEO Daniel Weinstein.

“Supply chain right now is super difficult. Vendor agreements are pretty crazy. [Just about] every PCBA house in the country is backed up with a huge backlog,” Weinstein said in an interview with Medical Design & Outsourcing.

“Our strength as a company is trying to find ways to beat the odds that are against companies — especially startups — in this industry,” he continued. “WeR…

This tiny saliva sensor could track acidity, glucose, medication and more

A rendering of Lura Health’s saliva sensor with a U.S. penny for scale [Image courtesy of Lura Health]

Lura Health has developed a tiny, wireless oral sensor for saliva monitoring to track acidity and much more in the years ahead.

The company aims to start by noninvasively measuring saliva acidity to help prevent tooth decay, which is the most prevalent health condition globally and the most common chronic disease in children and young adults.

“It affects at some point around 90% of Americans,” Lura Health co-founder and CEO Daniel Weinstein said in an interview with Medical Design & Outsourcing. “There’s a population set for which it imposes a huge burden. And dental expenditures are $162 billion or more in the U.S. alone, so it’s a big economic and health toll.”

Weinstein founded the company in 2017 with Chief Medical Officer Dr. Saam Bozorg and Chie…

MedAccred gives first PCBA accreditation in Mexico

NEWS RELEASE: Jabil Mexico achieves MedAccred accreditation for printed circuit board assembly at Chihuahua facility

[Photo courtesy of Jabil]

Jabil’s site in Chihuahua, Mexico, has earned the prestigious MedAccred Accreditation for Printed Circuit Board Assembly (PCBA) after meeting the stringent audit requirements set by MedAccred subscribing members – including Baxter, BD, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, Roche Diagnostics and Stryker. It is the only site in Mexico to currently hold MedAccred PCBA Accreditation.

The MedAccred audit and accreditation program is unique as the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry. The accreditation assures that critical manufacturing processes meet industry consensus requirements, leading to the production of high-quality end products, ultimately enhancing patient…

The flaw that likely caused Medtronic’s massive ICD and CRT-D recall — and why they’re too risky to replace

Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators that may fail to deliver life-saving shocks for cardiac patients. [Photo courtesy of Medtronic]

Medtronic identified a likely design flaw that can cause defibrillator implants to halt life-saving shocks for cardiac patients.

An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).

The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to healthcare providers.

Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 201…