AI, digital health feature in latest batch of FDA breakthrough device designations | MedTech Dive

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FDA has issued another batch of breakthrough device designations. The latest crop sees the agency grant regulatory privileges to a set of AI and digital health companies including Koios Medical and Nēsos.
Koios landed breakthrough status for AI software designed to enable the early detection of breast and thyroid cancer. The software analyzes breast and thyroid ultrasound images to help radiologists determine if a biopsy is needed. Koios is pitching the system as a way to both prevent unnecessary biopsies of benign tissues and improve cancer detection rates.
Perimeter Medical Imaging AI also secured breakthrough designation for an AI-enabled approach to imaging. FDA awarded the status to Perimeter's Optical Coherence Tomography Imaging System coupled with ImgAssist AI. The imaging system, which is already cleared by FDA in the evaluation of excised human tissue microstructure, is designed to provide real-time, ultra-high-resolution images. Perimeter is incorporating AI to help surgeons tell if cancer is still present after surgical excision.
Two other digital-focused medtechs recently received breakthrough designations. FDA awarded the status to Nēsos'prescription digital therapeutic for rheumatoid arthritis. The device consists of earbuds that deliver electrical signals to modulate neurological pathways and, in doing so, rewire the immune system to reduce the severity of rheumatoid arthritis.
Digital health company Implandata Ophthalmic Productsreceived FDA breakthrough status for its Eyemate system. The system consists of an implantable micro sensor designed to facilitate the continual remote monitoring and management of glaucoma patients. Implandata is framing the device as a way for physicians to keep tabs on the glaucoma status of their patients between office visits, which it says typically happen two to four times a year.
In addition to AI and digital health, FDA awarded breakthrough designations to cancer and orthopaedic devices. Medtronic received the designation for its Emprint ablation catheter kit. The catheter is designed to be used with the Emprint microwave generator and Medtronic lung navigation platform in the minimally invasive treatment of malignant lung lesions. Medtronic's goal is to enable the accurate delivery of microwave energy to target lesions.
IceCure Medical picked up the other recent cancer-related breakthrough status. FDA awarded the designation to ProSense, a cryoablation system for the treatment of certain breast cancer patients. The device consists of a probe that is inserted into the tumor, guided by CT or ultrasound. Once the probe is at the target site, liquid nitrogen is used to generate sub-zero temperatures that kill cancer cells.
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In the orthopaedic sector, FDA granted breakthrough designations to Bioretec and Cerapedics. Bioretec received a breakthrough device designation for its bioresorbable RemeOs Screw. The screw is designed to provide temporary support to aid bone healing, giving it applications in the fixation of fractures and the correction of deformities or malalignments. As the screws are bioresorbable, no follow-up surgery is needed to remove the devices.
Cerapedics' breakthrough status covers a treatment for degenerative disc disease. The bone graft is based on a small peptide technology platform and is intended to provide an alternative to using the patient's own bone or donor bone in procedures to fuse bones surrounding a damaged disc.
FDA also awarded breakthrough device status to a few products outside of the digital, cancer and orthopaedic realms. Fractyl Laboratories received the designation for a treatment to improve glucose control in patients with Type 2 diabetes while cutting insulin use. The approach entails using heat to resurface the lining of the upper intestine. As the upper intestine is involved in metabolic regulation, Fractyl sees the intervention as a way to enable the control of blood sugar without using insulin.
The agency also granted breakthrough status to Quadrant Biosciences' Clarifi ASD autism saliva test. The test looks for RNA epigenetic biomarkers that, when assessed alongside patient characteristics, Quadrant says could accelerate autism referrals to enable early intervention when treatment is most effective. The test is designed to help diagnose autism spectrum disorder in children as young as 18 months.
Micro Medical Solutions received breakthrough device status for its MicroStent vascular system. The system is in development in critical limb-threatening ischemia resulting from peripheral artery disease. By maintaining vessel patency and improving wound treatment, MMS says the device could reduce amputation and mortality.

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