MassDevice Archives - Page 187 of 587 - Medical Design Sourcing

Viz.ai launches AI-powered radiology suite

Viz.ai announced today that it launched an AI-powered radiology suite for alerting radiologists and connecting care teams in real-time.

San Francisco-based Viz.ai designed the suite to alert radiologists in their workflow of suspected diseases. It also prioritizes worklists and connects care teams while integrating into picture archiving and communications systems (PACS). This helps to securely facilitate access to imaging data across departments while streamlining patient diagnosis.

“With an increasing demand for imaging studies and a global shortage of radiologists, technologies that can be easily integrated into radiology workflows to enhance efficiency and streamline patient care are sorely needed,” said Dr. Allan Brook, director of interventional neuroradiology at Montefiore Medical Center and professor of radiology and neurosurgery at Albert Einstein College of Medicine. “The Viz Radiology Suite offers radiologists important capabilities for optimizing im…

Ypsomed, CamDiab launch first automated insulin dosing system with Abbott FreeStyle Libre 3

[Image from Ypsomed]Ypsomed announced that its mylife Loop now has authorization to work with the Abbott FreeStyle Libre 3 sensor in Germany.

The Ypsomed mylife YpsoPump combines with the CamDiab mylife CamAPS FX algorithm and FreeStyle Libre 3. Together, they form an intelligent and automated insulin delivery (AID) system for people with type 1 diabetes. Users can better control glucose levels and alleviate the burden of daily diabetes management.

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

Data backs Boston Scientific Acurate neo2 aortic valve

Acurate Neo2 [Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced positive results from its post-market clinical follow-up study for the Acurate neo2 aortic valve system.

Marlborough, Massachusetts-based Boston Scientific’s findings included a high procedural success rate of 98.4%. The study observed low rates of mortality and paravalvular leak (PVL).

Findings, presented at PCR London Valves 2022, simultaneously published in EuroIntervention, according to a news release.

The European study included a primary safety endpoint of all-cause mortality set at 0.8% at 30 days. Data also demonstrated that no patients experienced greater than moderate PVL. It found that 1.9% experienced moderate PVL and 18.9% experienced mild PVL. Other findings included a low 6.5% rate of new pacemaker implantation at 30 days post-procedure. Boston Scientific’s device demonstrated no incidence of disabling stroke or acute kidney injury.

“Wit…

Bionaut Labs closes $43M Series B for robotic drug delivery tech

[Image from Bionaut Labs]Robotic drug delivery technology developer Bionaut Labs announced today that it closed a Series B financing round worth $43.2 million.

Los Angeles-based Bionaut Labs uses microscale robots to deliver drugs for treating central nervous system (CNS) diseases and disorders. Through magnetic propulsion, the company’s Bionauts can navigate the human body and deliver drugs locally.

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

Edwards announces positive results for Evoque valve replacement system

The Evoque transcatheter tricuspid valve replacement system. [Image from Edwards Lifesciences]Edwards Lifesciences (NYSE:EW) announced that one-year results from the TRISCEND study demonstrated favorable outcomes.

TRISCEND, a single-arm, prospective, global, multi-center study, evaluates the Edwards Evoque system. Evoque, a transcatheter tricuspid valve replacement system, demonstrated favorable safety, efficacy and quality-of-life outcomes.

Edwards presented data during the late-breaking trials session at PCR London Valves 2022.

Patients enrolled in the trial had symptomatic moderate or greater functional or degenerative tricuspid regurgitation (TR). They had TR despite optimal medical therapy. The trial enrolled 176 patients. Edwards said in a news release that this represents the largest dataset among transcatheter tricuspid valve replacement therapies.

The company earlier reported positive 30-day and 6-month results. One-year outcomes demonstrate…

GE HealthCare, Philips promote role of AI in imaging

The ROCC interface. [Image from Philips]GE HealthCare and Philips (NYSE:PHG) recently announced developments in the area of AI-powered imaging technology.

SIGNA Experience, a GE HealthCare platform including four technologies, helps users through their diagnostic journey. It aims to ensure the smoothest MRI scanning experience for physicians, technologists and patients.

The platform features an intuitive user interface for high-quality MRI, according to a news release. Its deep-learning AI algorithms, including AIR Recon DL, seek to improve signal-to-noise ratio. They also offer improved image sharpness and a shorter scan time, GE HealthCare said.

Automated intelligent workflow technologies and AIR coils offer further improvements in the MRI experience. SIGNA’s workflow allows technologists to keep track of progress at a glance. Its visually-assisted highlighted fields guide them step-by-step and intelligent automation highlights the most likely actio…

Baxter’s smart incontinence pad recall is Class I

The WatchCare system is a smart incontinence pad that integrates into healthcare facility bed. [Image courtesy of Baxter]The FDA issued a notice declaring the Baxter (NYSE:BAX) WatchCare incontinence management system (IMS) recall as Class I, the most serious kind.

Baxter last month issued an urgent medical device correction for the WatchCare IMS. The system appears to radiate radiofrequency (RF) that may affect other devices on caregivers and patients. The list of potentially affected devices includes infusion/insulin pumps, blood glucose sensors, fetal monitors/dopplers, telemetry devices and bladder scanners.

Other third-party medical devices may be affected, too, according to the FDA notice. RF interference could cause erroneous readings or malfunctions of the devices on both patients and staff.

Baxter reported 96 complaints of RF interference. To date, all cases but two experienced interference at a distance less than one meter. The company said it has…

GE completes $8.5 billion offering to help finance GE HealthCare spinoff

GE (NYSE:GE) announced that its GE HealthCare subsidiary closed an offering of senior notes worth $8.5 billion.

The company earlier this month announced the offering in connection with the planned spinoff of GE HealthCare. It anticipates the spinoff to go through in the first week of January 2023.

According to a news release, GE’s offering includes $1 billion in 5.55% senior notes due in 2024. It also offers $1.5 billion in 5.6% senior notes due in 2025. The offering features $1.75 billion in 5.65% senior notes due in 2027.

Additionally, GE is offering $1.25 billion in 5.857% senior notes due in 2030 and $1.75 billion in 5.905% senior notes due in 2032. Finally, GE offered $1 billion in 6.377% senior notes due in 2052.

GE said the notes represent senior unsecured obligations of GE HealthCare. The company expects them to enable GE to pay down existing debt. On Nov. 8, GE announced a tender offer to buy up to $7 billion in its debt securities.…

AnchorDx enrolls first patient in bladder cancer assay trial

AnchorDx announced today that it enrolled the first patient in its UriFind bladder cancer assay clinical trial in the U.S.

Guangzhou, China-based AnchorDx’s multi-center, prospective trial includes more than 1,000 patients. It tests the non-invasive, quantitative real-time PCR assay in targeted patients. AnchorDx expects the trial to include about 10 sites of urology clinics and three CAP/CLIA laboratories.

The company designed the assay to detect two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer. In July 2021, the FDA granted the assay breakthrough device designation.

AnchorDx plans to use the results of the trial to move toward meeting the requirements for premarket approval in the U.S. The company said its assay’s performance showed improved sensitivity and specificity over cytology and other assays. It can detect early, micro, residual and recurrent bladder cancer. The company said it provi…

GE Healthcare donates $1M in ultrasound and monitoring equipment to Ukraine

GE HealthCare announced today that it made a donation of ultrasound and monitoring equipment worth $1 million to Ukraine.

The company said it made the donation in support of the country as the ongoing war takes a toll on its healthcare system. The donation includes patient monitors and handheld and stationary ultrasound devices, according to a news release.

GE HealthCare said Ukraine can use its monitoring technology for monitoring vital signs at bedside in the general ward and ICUs. Ultrasound devices can cover various clinical uses, including emergency care, obstetrics and gynecology. Ukrainians can use them both inside and outside the hospital.

GE’s efforts to aid Ukraine

The company’s latest donation adds to a $4 million equipment donation made in March 2022. The GE Foundation also donated $500,000 to the International Rescue Committee (IRC) and Airlink. That provided relief to neighboring countries welcoming refugees from Ukraine. The GE…

More deaths reported in Philips respiratory devices recall

The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall.

It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the seriousness of the Philips recall. The previous update in late summer listed 69,000 MDR entries since April 2021, including 168 reports of death.

New Philips CEO Roy Jakobs publicly apologized for the Philips Respironics recalls last month. The recalls involve 5.5 million CPAP and BiPAP ventilators and other respiratory devices.

In addition to consent decree talks with the DOJ and FDA, Philips also faces lawsuits.

The recall involves potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway. The p…

Fujifilm installs ultrasound tech in radiology centers throughout California

The Arietta 650 DeepInsight. [Image from Fujifilm]Fujifilm Healthcare Americas announced today that installations began for its Arietta 650 DeepInsight ultrasound systems in California.

United Medical Imaging Healthcare in Los Angeles started installing the systems across its radiology facilities in southern California. This comes as part of a volume purchase agreement between the two companies.

According to a news release, these represent the first systems installed in the U.S. that use DeepInsight technology. DeepInsight offers cognitive technology for extracting only necessary information from image raw data. This helps deliver clearer images, Fujifilm said.

“Ultrasound imaging has become an indispensable diagnostic tool in modern medicine,” said Hideyuki Honda, VP of ultrasound solutions and business development, Fujifilm Healthcare Americas. “However, ultrasound images are often subject to noises generated in the system, which can make it difficult to …