MedTech News Briefs | January 22nd, 2024

Monday January 15th

Canon Medical and Olympus have collaborated to develop the Aplio i800 Endoscopic Ultrasound (EUS) system. The partnership aims to provide advanced EUS equipment for high-quality image diagnoses, with a focus on technological advancements and diagnostic performance in the EUS field, starting with the European market in Q1 2024.
The FDA has granted approval to Darmiyan for its clinical brain test, BrainSee, designed to aid physicians in determining the prognosis of patients with amnestic mild cognitive impairment (aMCI). Using artificial intelligence (AI) algorithms to analyze MRI scans, BrainSee generates an objective score predicting the likelihood of patients progressing from aMCI to Alzheimer’s dementia within five years, addressing the need for early diagnosis and intervention in Alzheimer’s disease.
Researchers at the University of Iowa have developed a drinkable foam infused with carbon monoxide that enhances the effectiveness of autophagy inhibition in mice and human cells. The findings suggest that the foam, created using gas-entrapping materials, could be a promising approach to improve cancer therapies in human clinical trials.

Integer Holdings has acquired Pulse Technologies, an engineering and contract manufacturing firm focused on complex micromachining of medical device components. The deal was valued at $140 million, with an additional consideration contingent on achieving specific revenue growth targets through 2025.
Nexa3D has acquired Essentium, a company known for its high-speed extrusion 3D printers and expertise in super polymers. The acquisition aims to broaden Nexa3D’s additive manufacturing capabilities and provide access to industrial, health, and government customers.
Aerotech has introduced the Automation1 XA4 and iXA4 PWM servo drives, providing precise, powerful control for single- and multi-axis motion. These panel-mounted servo motor drives include a full motion controller and I/O expansion options, enabling faster build times, improved quality, and higher throughput in less development time for machine builders and automation solution providers.

The FDA has cleared DermaSensor’s AI-powered skin cancer evaluation system, which uses real-time, non-invasive optical spectroscopy to assess lesions. The handheld device demonstrated high sensitivity and the ability to reduce missed skin cancer cases, potentially improving collaboration between primary care and dermatology for more effective patient care.
The FDA has granted de novo approval to Imvaria’s Fibresolve, an AI-powered test for non-invasive diagnosis and subtype classification of idiopathic pulmonary fibrosis (IPF) in cases involving other interstitial lung diseases. Imvaria’s deep learning algorithm reduced the need for invasive surgical biopsies by 41%, providing an adjunct to clinicians in assessing patients with suspected lung fibrosis, potentially facilitating earlier treatment.
Maternal health company Bloomlife has received FDA clearance for its Bloomlife MFM-Pro device, a prescription-based wearable designed to monitor maternal and fetal heart rates in both home and clinical settings. The device, which non-invasively measures the body’s electrical activity, aims to provide evidence-based, cost-effective, high-quality, patient-centered care by leveraging technology to shift care from high-cost clinical environments to the home.

Orthofix Medical has entered into an agreement with MRIguidance to distribute its BoneMRI imaging software in the U.S. The BoneMRI software creates a synthetic CT from an MRI imaging exam without using harmful radiation, enabling radiation-free preoperative imaging and spinal navigation.
Onward Medical has initiated the HemON NL clinical feasibility study to evaluate its ARC-IM neurostimulation therapy for addressing hemodynamic instability after spinal cord injury (SCI). The study, conducted at Sint Maartenskliniek in the Netherlands, aims to assess the safety and effectiveness of the therapy, with plans to prepare for the expected initiation of the Empower BP global pivotal trial.
Paragon 28 has launched the Bun-Yo-Matic Lapidus Clamp System, designed to provide a more reproducible method for restoring the foot’s three-dimensional alignment during a Lapidus procedure for bunion treatment. The system, used in conjunction with other implants and systems for bunion treatment, includes a reusable clamp that remains attached to the anatomy throughout the surgery, ensuring surgeon-guided correction and anatomic alignment are maintained until fixation is applied.

Scientists at the University of North Carolina at Chapel Hill have developed a wireless, smartphone-controlled drug delivery system called the Spatiotemporal On-Demand Patch (SOP). The patch, resembling a Band-Aid, features microneedles that can release drugs in response to wireless commands, offering a convenient and customizable treatment approach for chronically ill patients, with potential applications in neurodegenerative disorders like Alzheimer’s disease.
Kindeva Drug Delivery, a global contract development and manufacturing organization (CDMO), has acquired Summit Biosciences, a specialist in nasal drug delivery. The acquisition enhances Kindeva’s capabilities in serving biopharma customers with complex drug-device combination products, particularly in nasal drug delivery, a preferred dosage format for various indications.
Axogen has announced positive topline results from the REPOSE study, evaluating its Axoguard Nerve Cap. The study compared the standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with the Axoguard Nerve Cap, showing a reduction in pain as measured by the visual analog scale.