News and Resources from the WTWH Media Life Science Network - Page 7 of 977

Front Line Medical wins CE mark for COBRA-OS device

Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device.

The CE mark gives EU medical providers access to the Control Of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS). The device already has FDA clearance and Health Canada approval.

“The CE marking of the COBRA-OS is momentous for our company, as it reinforces our dedication to technological excellence and our unwavering commitment to better patient care,” CEO Dr. Asha Parekh said in a news release. “Day in and day out, our pursuit of helping to save as many lives as we can is what drives our entire team, and this regulatory achievement means we are further on our way to accomplishing that goal.”

COBRA-OS is a 4 Fr aortic occlusion device that doesn’t require an over-the-wire technique. The company said it is one of the smallest life-saving Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) devices c…

Front Line Medical wins CE mark for COBRA-OS device

Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device.

The CE mark gives EU medical providers access to the Control Of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS). The device already has FDA clearance and Health Canada approval.

“The CE marking of the COBRA-OS is momentous for our company, as it reinforces our dedication to technological excellence and our unwavering commitment to better patient care,” CEO Dr. Asha Parekh said in a news release. “Day in and day out, our pursuit of helping to save as many lives as we can is what drives our entire team, and this regulatory achievement means we are further on our way to accomplishing that goal.”

COBRA-OS is a 4 Fr aortic occlusion device that doesn’t require an over-the-wire technique. The company said it is one of the smallest life-saving Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) devices c…

Rilzabrutinib on track for regulatory filing after ITP trial win

Sanofi revealed that its investigational BTK inhibitor rilzabrutinib notched a significant win in the LUNA 3 phase 3 study, hitting the primary endpoint of durable platelet response in adults with persistent or chronic immune thrombocytopenia (ITP). The study showed a significantly higher proportion of rilzabrutinib-treated patients achieved the platelet response goal compared to placebo in this difficult-to-treat ITP population.

“The LUNA 3 results reinforce rilzabrutinib’s potential to provide clinically meaningful benefits for people living with severe immune diseases like ITP,” said Houman Ashrafian, Sanofi’s head of R&D. The company expects to file regulatory submissions for rilzabrutinib in the U.S. and EU by year-end.

Rilzabrutinib received Fast Track Designation from FDA for ITP in November 2020 and also previously won Orphan Drug Designation.

The small molecule became part of Sanofi’s pipeline in 2020 via its $3.6 bil…

Non-insulin, basal CGM use exceeds analysts’ expectations, Dexcom and Abbott to benefit

Left, the Dexcom G7. Right, the Abbott FreeStyle Libre 2. [Images from Dexcom and Abbott]William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations.

Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management.

Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle Libre 3). Dexcom also began rolling out its Stelo over-the-counter non-insulin CGM and Abbott has its Lingo non-insulin biowearable coming to the U.S. soon.

According to Kaczor, the number of non-insulin patient adds in 2023 proved surprising and came in above expectations. William Blair estimates nearly 300,000 new non-insulin CGM users, compared to a projection of 200,000. She sees this as an additive to the still-underpenetrated opportunity in the insulin-using diabetic patient population. Read more

FDA clears Epitel remote monitoring tech, AI detection platform

A rendering of the Remi system. [Image from the Epitel website]Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings.

The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI analyzes and marks Remi EEG records for potential electrographic seizures to assist with ease and accuracy of interpretation.

Remi ambulatory allows for an extended EEG in the comfort of the home while going about daily activities. It leverages the same sensors used in the Remi platform for healthcare facility use and adds a mobile computing platform. This allows patients and caregivers to mark when they’ve experienced an event or suspected event.

Epitel designed Remi Vigilenz AI for detection to levarage state-of-the-art proprietary machine…

Vantage MedTech names Jim Bartel as CEO

Jim Bartel, CEO of Vantage MedTech [Image courtesy of Vantage MedTech]Vantage MedTech today announced it appointed Jim Bartel as CEO.

Bartel has more than 25 years of leadership experience within the medical device and contract manufacturing industries. He has held various roles in leading marketing, business development and sales teams.

Most recently, Bartel was CEO and board member of Waltek, a private equity-owned casting and machining company in the medical industry, and was president of Spectralytics, a medical device contract manufacturing firm. He has also held leadership roles at Precision ADM and Stratasys.

“Vantage has been on an exciting growth journey, and I’m grateful for the opportunity to serve as CEO. We have a talented team of 150+ medical device engineers with decades of industry expertise. Their dedication to partnering with medical device innovators from concept to realization is what makes Vantage stand apart and is key to o…

Bruker to acquire NanoString business

Bruker this week announced it entered into a definitive acquisition agreement with NanoString Technologies.

Under the agreement’s terms, Bruker will substantially acquire all of the assets and rights associated with NanoString’s business for approximately $392.6 million in cash and the assumption of certain liabilities.

The transaction was approved under a court-supervised Chapter 11 sale process pursuant to Section 363 of the U.S. Bankruptcy Code. It is expected to close in the second quarter of 2024 and is subject to customary closing conditions.

NanoString develops life science tools for discovery and translational expression analysis. Its revenues were $168 million in 2023.

“The acquisition of NanoString will add gene expression profiling and spatial transcriptomics solutions and products to Bruker’s spatial biology portfolio,” Mark Munch, President of Bruker Nano Group, said in a news release. “NanoString’s innovative platforms ar…

Neuronoff hits first-in-human milestone for Injectrode neuromod

Injectrode placement over the course of treatment. [Image courtesy of Neuronoff]Neuronoff announced today that it completed the first-in-human clinical trial evaluating its flagship Injectrode neuromodulation product.

The Cleveland-based company designed Injectrode to treat chronic pain. The LIFE (lumbar Injectrode feasibility evaluation) trial evaluated Injectrode’s safety and effectiveness, meeting all goals, the company said. Injectrode placement comes through an 18-gauge needle (no incisions) under local analgesia at the level of the skin and subdermis. Doctors determine placement location using fluoroscopic visualization then confirm it with electrical test stimulation during placement.

According to a news release, 10 participants received Injectrodes (injectable electrodes) placed unilaterally or bilaterally near the dorsal rami innervation to the erector spinae and multifidus muscles in the lower back for less than 30 days. Peripheral nerve stimulatio…

Thermedical completes feasibility study to use SERF with PFA

[Image from Thermedical]Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system.

Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to treat ventricular tachycardia (VT).

According to Thermedical, SERF (saline-enhanced radio frequency) ablation provides a new, more efficient form of biological heat transfer than conventional RF ablation methods. The company says its Durablate catheter delivers energy with a high level of accuracy. It treats tissue deeper in the heart wall, where arrhythmias causing VT often appear.

Thermedical is evaluating SERF with Durablate as a treatment for arrhythmias resistant to antiarryhtmic drugs or standard ablation. It believes that adding PFA to SERF ablation could offer a more complete approach to VT ablation.

“We are encouraged by the results from our pre-clinical feasibility study ev…

FDA clears computer-assisted thrombectomy system from Penumbra

The Lightning Flash 2.0 computer-assisted thrombectomy system. [Image courtesy of Penumbra]Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system.

Lightning Flash 2.0 represents the next generation of the company’s computer-assisted vacuum thrombectomy (CAVT) technology. It removes the venous thrombus to treat pulmonary emboli (PE).

The system features Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow. Combined with Penumbra’s novel catheter technology, the new advancements help to better navigate the patient’s anatomy. This helps to deliver high power for clot removal with possible minimal blood loss.

Dr. James F. Benenati, chief medical officer at Penumbra said the company already has positive feedback from its initial launch. Early reports showed improved procedure time through shortened aspiration time, plus redu…

Exo adds AI-powered cardiac, lung apps to handheld ultrasound

The Iris handheld ultrasound system now has clearance for AI lung and cardiac applications. [Image courtesy of Exo]Exo announced today that it launched its FDA-cleared cardiac and lung AI applications for the Iris handheld ultrasound device.

The company now has FDA clearance for five different applications on Iris — cardiac, lung, bladder, hip and thyroid. It expects to double that number by 2025.

Iris delivers high-performance medical imaging at a fraction of the size and cost of cart-based ultrasound. The system, built on Exo’s advanced silicon technology, fits in the pockets of caregivers. It enables immediate answers at the point of care for physicians, nurses, EMTs and clinicians in emergency, acute care, outpatient and home settings.

Exo unveiled the device for versatile imaging performance in point-of-care ultrasound (POCUS) in September 2023.

The company says the launch of its latest Iris functions simplify the process of obtaining and interp…

Study combines biomimetic AI, digital twins and multiomics to unveil potential genetic drivers of endometriosis

The study developed a biomimetic digital twin ecosystem that tailors analysis to endometriosis research. This system integrates expert knowledge and raw clinical data to improve identification and analysis of molecular profiles linked to the disease. Image licensed under Creative Commons from The Journal of Molecular Diagnostics. https://doi.org/10.1016/j.jmoldx.2024.03.004, Figure 2.

Endometriosis, a condition where endometrial tissue grows outside the uterus, has a strong genetic underpinning. A new study published in the Journal of Molecular Diagnostics sheds light on this connection. Researchers from a team including Genzeva, LumaGene, RYLTI Biopharma, Brigham & Women’s Hospital of Harvard University and QIAGEN Digital Insights used a unique approach in their analysis of endometriosis patient samples. They combined multiple data sources, spanning multiomics data, next-generation sequencing, phenot…