MassDevice Archives - Page 423 of 587 - Medical Design Sourcing

Study shows CGMs better at controlling blood sugar in type 2 diabetes

Kaiser Permanente touts a study demonstrating that using continuous glucose monitors offers better blood sugar control for patients with type 2 diabetes.

Patients with insulin-treated type 2 diabetes using continuous glucose monitors (CGMs) typically had better blood sugar control and fewer visits to the emergency room for hypoglycemia, the study found. The study was published yesterday in JAMA and was supported by an independent investigator award from Dexcom and funding from the National Institute of Diabetes and Digestive and Kidney Diseases.

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

Italian sterilization plants falsified records for years, FDA says

Device sterilized by ethylene oxide (EtO) (Image from the FDA)

An Italian medtech sterilization company falsified records of a variety of FDA-regulated products since 2016, the agency said today.

The company, Steril Milano, falsified graphs and parameters of sterilization certificates for devices processed at its Reggiolo and Monza ethylene oxide (EtO) plants, the FDA said.

Steril Milano on March 9, 2021, announced the temporary closure of the Monza and Reggiolo sites for further investigations following a review of operating procedures. The company said that it has taken steps to strengthen the quality control processes at its Biassonno site. Steril Milano’s certifying body has suspended the certification for its Italian sites, the company added.

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New FDA-backed initiative seeks to boost diversity in medtech

MedTech Color launched of a Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research.

The MedTech Color Collaborative Community aims to bring together public and private stakeholders and develop targeted strategies to up the awareness, understanding and participation of racial and ethnic minorities within the medtech industry, according to a news release.

“The FDA is committed to advancing diverse participation in trials to ensure that clinical studies better reflect the populations that will ultimately benefit from new and innovative health solutions,” director of the FDA’s Center for Devices & Radiological Health (CDRH) Dr. Jeff Shuren said in the release. “We are encouraged by MedTech Color’s active efforts to develop solutions to increase participant diversity and inclusion of minority health populations. We are also pleased to have FDA liaisons from CDRH and the Office …

FDA seeks more money, authority in budget request

The FDA wants more money from Congress for the coming fiscal year, and more power, too.

Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory Affairs (ORA).

The request includes $452 million that would come from Congress— up nearly $44 million from FY 2021 — and $224.5 million from user fees, a $4.9 million increase.

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Medtronic touts real-world results for MiniMed 780G insulin pump

Medtronic (NYSE:MDT) today announced positive real-world outcomes for thousands of patients using the MiniMed 780G insulin pump system.

Fridley, Minn.-based Medtronic’s MiniMed 780G system automates and personalized the delivery of basal insulin through adjustments every five minutes for 24 hours a day. It includes an advanced algorithm designed to automatically correct highs every five minutes through autocorrelation dosing, while it also protects against lows.

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

Sientra names VP of R&D

Sientra (NSDQ:SIEN) today said it appointed Denise Dajles as VP of research and development, effective June 2.

Dajles will lead the Santa Barbara, Calif.-based company’s R&D and medical affairs teams and will report to CEO Ron Menezes.

“We are pleased to welcome Denise to the Sientra management team,” Menezes said in a news release. “With her considerable technical and international expertise, Denise is well-suited to lead our R&D organization as we pursue our goal to be the leader in bringing transformative treatments and technologies to market that progress the art of plastic surgery. I am confident that Denise will provide the leadership and strategic direction to enable us to advance our development of proprietary innovations that improve how plastic surgeons care for their patients.”

Prior to joining the company, Dajles served as senior director of research, development, and innovation at Establishment Labs. She…

Avicenna.AI’s triage system get regulatory nods

Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system.

Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release.

Cina Chest offers rapid, automatic PE detection on CT chest angiography with accurate and real-time alerts, while it identifies acute AD cases that require urgent intervention on thoraco-abdominal CT angiography.

“At Avicenna, we specialize in the development of AI algorithms that can identify acute abnormalities, and Cina Chest is the latest application we’ve developed to enhance emergency room radiology,” Avicenna.AI co-founder & CEO Cyril Di Grandi said in the release. “Our PE and AD triage tools are the third and fourth algorithms we’ve…

Butterfly Network wins Canadian approval for next-gen handheld ultrasound

The Butterfly Network IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE: BFLY) announced today that Canada has approved its second-generation iQ+.

Butterfly Network touts the iQ+ features what the company describes as the world’s only Ultrasound-on-Chip technology, boasting hardware and software advances to improve usability and care delivery.

“We are excited that the Butterfly iQ+ will now be available for purchase by Canadian medical professionals,” said Butterfly Network CEO Dr. Todd Fruchterman. “Thousands of new practitioners and millions of patients will now have access to a transformative advanced assessment tool that can deliver valuable insights that enable more informed clinical decisions at the point of care.”

The IQ+ is now available in the United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland…

FDA authorizes Cognoa autism spectrum disorder diagnostic aid

U.S. FDA today authorized Cognoa’s machine learning-based software to help diagnose autism spectrum disorder.

The de novo authorization from FDA covers the use of the Cognoa ASD Diagnosis Aid with children 18 months through 5 years of age with potential ASD symptoms. Palo Alto, Calif.–based Cognoa has touted the software as a way to do away with the time delays parents can experience as they try to schedule their children with specialists after a referral from a pediatrician.

“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.

The Cognoa ASD Diagnosis Aid uses a machine-learning algorithm to receive input fro…

CardioFocus, China Grand Pharmaceutical partner to commercialize catheter ablation system in China

CardioFocus today announced that it signed a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China.

Marlborough, Mass.-based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment for atrial fibrillation (AFib).

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

An expert’s guide to developing medical devices

When it comes to designing and building novel medical devices to meet the needs of patients and healthcare systems, developers should rely on the core skills of engineering and design to inform their process. But there are “lessons learned” that are unique to the medical device development process.

The team at Goddard has contributed to hundreds of medical device development projects. Here are some of our top tips for creating innovative medical technology.

Human Factors Engineering as a Means to Mitigate Potential Harm for the Patients

Human factors engineering is a critical part of the product development process. And for medical device development, this work is mandated thanks to the medical device regulations put forth by the FDA.

Human factors engineering is defined as the interaction between humans and systems. It can apply to everything from a button’s size to the room that the product will be in.

Human factors engineering activi…

Preceptis Medical launches tympanostomy tube system for in-office pediatric ear tube procedures

Preceptis Medical today said it has launched its Hummingbird tympanostomy tube system for office-based pediatric ear tube procedures.

The Maple Grove, Minn.-based company designed the device with an ergonomic design to allow for more efficient ear tube delivery in children.

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