MedTech News Briefs | December 26, 2023

Here is the latest news in MedTech

Monday December 18th

Elutia has submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix, CanGarooRM, designed for use with cardiac implantable electronic devices like pacemakers and defibrillators. The CanGarooRM is a bioenvelope made from a natural biomaterial that promotes regenerative healing and contains a slow-release formulation of antibiotics to reduce bacterial colonization, and the company anticipates an FDA approval decision in the first half of 2024.
Zimmer Biomet’s spinoff Zimvie is splitting again, with H.I.G. Capital set to acquire its spine, motion preservation, and EBI bone healing technologies. The move aims to create a more focused Zimvie with a leading position in the global dental market, and the sale is expected to be completed in the first half of 2024, subject to regulatory approvals
Neuronetics has received FDA clearance for its NeuroSite Coil placement accessory, designed to assist with accurate coil placement in transcranial magnetic stimulation (TMS) devices used for treating major depressive disorder. The tool reduces patient setup time and is compatible with both legacy and new NeuroStar systems, providing a valuable option for patients who don’t respond to antidepressant medications.

Tuesday December 19th

The Health Innovation Fund, set to launch on January 1, 2024, will provide support ranging from £5,000 to £10,000 to small and medium-sized enterprises (SMEs) in the East Midlands or businesses collaborating with East Midlands healthcare system partners. The fund aims to boost late-stage innovations that are market-ready but need financial support to overcome barriers to market entry, with a focus on technologies relevant to the health and care sector.
TekniPlex Healthcare has completed the acquisition of Seisa Medical, a move that enhances the former’s medical technology solutions platform. This acquisition strengthens TekniPlex Healthcare’s materials science and process technologies for minimally invasive and interventional therapy devices globally, positioning it as a full-fledged contract development manufacturing organization in the medical materials science space.
CMR Surgical’s next-generation Versius surgical robot has been adopted by Kreiskrankenhaus Rotenburg, a hospital in Germany, marking the hospital’s first introduction of robotic surgery. The hospital plans to use Versius for a range of procedures, including complex visceral surgery, abdominal tumor surgery, colorectal surgery, hernia surgery, and general surgery.

Wednesday December 20th

ShiraTronics has successfully implanted its Chronic Migraine System in six patients as part of the RELIEV-CM clinical study, marking a significant advancement in migraine treatment and neuromodulation. The fully implantable system, designed for the head using a minimally invasive technique, administers targeted electrical pulses to disrupt migraine pain signals, offering a potential new treatment modality for chronic migraines.
Cyted has received an Innovate UK grant to develop a non-endoscopic test for Eosinophilic Esophagitis (EoE), a chronic inflammatory condition of the esophagus. The EndoSign platform, already used in the Heartburn Health Check to identify patients at risk of oesophageal cancer, will be adapted to diagnose EoE, reducing the need for endoscopy and improving treatment decisions, leading to better patient outcomes and cost savings.
Moticont has introduced the HVCM-016-013-003-01 Hollow Core Voice Coil Linear Servo Motor, a miniature linear DC servo motor with an open aperture, high force-to-size ratio, and a continuous force rating of 5.7 oz (1.6 N). It features zero cogging, zero backlash, high acceleration, deceleration, and high speed, making it suitable for applications such as haptic feedback, medical diagnostic equipment, testing, optical focusing, laser beam steering, and more.

Thursday December 21st

Acclarent, a unit of Johnson & Johnson MedTech, has received new FDA clearance for its Aera Eustachian tube balloon dilation system, expanding access to children aged eight to 17 with persistent obstructive Eustachian tube dysfunction (OETD). The system was previously indicated only for adults, and this clearance makes Acclarent the first and only company to achieve a pediatric indication for a Eustachian tube balloon dilation system.
German medical technology company Lindis Blood Care has completed its trial of the Catuvab device, designed to remove cancerous cells from a patient’s blood during cancer-related surgery. The Remove study, one of the largest of its kind, enrolled 130 patients, and top-line results are expected in early 2024.
The FDA has granted breakthrough device designation to Pangea Laboratory’s Bladder CARE Assay, a non-invasive test for the quantitative detection of bladder cancer and upper tract urothelial carcinoma using urine samples. The CE-marked in vitro diagnostic test utilizes a single quantitative polymerase chain reaction (qPCR) reaction to measure the methylation levels of three DNA biomarkers specific to urothelial cancer.

Friday December 22nd

The first pediatric deformity surgery using Novarad’s VisAR, an augmented reality surgical navigation system, has been successfully performed at Washington University School of Medicine in St. Louis. The VisAR system overlays 3D image datasets onto the patient’s body through an augmented reality headset, providing real-time, three-dimensional visualization during surgery, with the technology gaining approval for spinal surgery and undergoing review for cranial surgery in the US.
BlueWind Medical has announced the availability of its implantable tibial neuromodulation (iTNM) device, Revi, in Shreveport, Louisiana, US, for patients suffering from urge urinary incontinence (UUI). Revi is the only battery-free iTNM implant on the market, providing a patient-centric solution for UUI with a minimally invasive outpatient procedure and a wearable component for device activation.
Savara has launched aPAP ClearPath, a blood test aimed at aiding US physicians in diagnosing autoimmune pulmonary alveolar proteinosis (aPAP), a rare autoimmune lung condition. The serum-based test detects autoantibodies against GM-CSF, providing a cost-free, non-invasive, and simple method for quantifying these autoantibodies in human serum.

Sources

ThinkMedTek