MedTech News Briefs | January 15th, 2024

January 8th, 2024

MET and Cormica Group have each made investments to enhance their medical device testing capabilities. MET has unveiled two walk-in Real-Time Ageing Chambers to expand its capacity for stability testing, while Cormica Group invested £235,000 in a dedicated building for its stability test programs in response to increased demand.
Laborie Medical Technologies has introduced the RenovaRP Centesis System, a fluid drainage device designed to improve efficiency for healthcare professionals and enhance patient care. The system expands the indication for thoracentesis and includes design enhancements to the handle and nest, aiming to provide an improved user experience for paracentesis and thoracentesis procedures.
OrthoPediatrics has acquired Boston Orthotics & Prosthetics to expand its newly launched Specialty Bracing division. The acquisition, for an undisclosed amount, enables OrthoPediatrics to offer a comprehensive continuum of care for pediatric orthopedic patients, including those who are not surgical candidates, by incorporating Boston O&P’s bracing, orthotic, and prosthetic technology for non-operative treatment.

January 9th, 2024

Dexcom is set to launch Stelo, a continuous glucose monitoring (CGM) device for people who don’t take insulin. The new device, based on the G7 CGM, is designed to last for 15 days and will feature custom software tailored for individuals who don’t require the alerts and alarms typically associated with insulin therapy.
Owlet has introduced two FDA-approved at-home infant monitors, Dream Sock and BabySat, designed to provide caregivers with real-time health insights for infants. Dream Sock, available without a prescription, monitors and displays a baby’s live health readings, including pulse rate and oxygen saturation level, while BabySat, available by prescription, offers hospital-grade accuracy and enables healthcare providers to set custom alarms for an infant’s oxygen saturation and pulse rate.
Vivoo, a health tech company, has unveiled a new at-home urinary tract infection (UTI) test that uses deep learning image processing technology for accurate results within seconds. The test, which takes two minutes to complete, aims to provide users with gold-standard accuracy, save time, and enable digital sharing of results with healthcare providers via the app, eliminating the need for sending samples for examination.

January 10th,2024

Surgeons have completed the first shoulder arthroplasty surgeries using Stryker’s Blueprint mixed reality (MR) guidance system, according to an announcement from the company. The system combines software with the Microsoft HoloLens 2 headset, allowing surgeons to track the position and orientation of surgical instruments and use 3D images and widgets to guide their procedures.
The Japanese Ministry of Health, Labor and Welfare has granted approval for Neurolief’s neuromodulation device, Relivion, for at-home use in the acute treatment of migraines. Relivion is a non-invasive brain neuromodulation technology that stimulates both the occipital and trigeminal nerve branches, responsible for migraines, and connects to a mobile app with remote monitoring capabilities.
Medtronic has received CE Mark approval for its MiniMed 780G system with Simplera Sync, an all-in-one continuous glucose monitor (CGM) that requires no fingersticks or overtape. The Simplera Sync sensor, half the size of previous Medtronic sensors, offers an improved user experience with a simple two-step insertion process, and the MiniMed 780G system is the company’s most advanced insulin delivery system, automatically adjusting glucose levels every 5 minutes.

January 11th, 2024

Micrometal, a company specializing in precision metal components, has received ISO 13485 certification for its photochemical etching (PCE) process, which is used in the production of precise components for medical devices. The PCE process, which involves using a special liquid resist system and glass digital tooling, is highly automated and continuous, ensuring excellent reproducibility and the attainment of tight tolerances, making it compelling for OEMs seeking intricate, geometrically complex, feature-rich, thin metal parts and components.
Smith+Nephew has reported positive results for its Regeneten bioinductive implant from a randomized controlled trial. The study found that medium and large full-thickness rotator cuff tears repaired and augmented with the implant had better tendon healing compared to the standard of care, with a significantly lower re-tear rate and three times lower risk of re-tear.
Excelitas Technologies has completed its acquisition of Noblelight, a business unit of Heraeus Group. Noblelight specializes in specialty lighting components and system solutions used in various applications, including analytical instrumentation, industrial curing, water treatment, electronics manufacturing, medical and cosmetic therapy, and battery production.

January 12th, 2024

The US FDA has granted investigational device exemption (IDE) approval for Endovascular Engineering’s ENGULF pivotal trial, which will evaluate the safety and effectiveness of its Hēlo Thrombectomy System in treating pulmonary embolism (PE). The single-arm, multi-center feasibility study demonstrated a significant reduction in the right ventricular to left ventricular ratio, a metric recognized by the FDA that increases morbidity and mortality in PE patients.
Neuralace Medical has received FDA clearance for its Axon Therapy, a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for Painful Diabetic Neuropathy (PDN). The therapy utilizes magnetic pulses to provide quick and painless relief, and in a recent double-blind randomized controlled trial, it demonstrated significant efficacy in improving subject outcomes.
Integer Holdings has acquired Pulse Technologies, a medtech supplier specializing in complex micromachining of medical device components for structural heart, heart pump, electrophysiology, leadless pacing, and neuromodulation markets. The approximately $140 million deal aligns with Integer’s strategy to expand its capabilities and capacity in targeted growth markets.

Sources

ThinkMedTek