Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy […]
510(k)
Embecta submits insulin patch pump for FDA clearance
Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It […]
FDA clears next-gen handheld ultrasound from Butterfly Network
Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system. BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%. The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- […]
Nanowear wins FDA nod for AI-enabled wearable blood pressure monitor
Nanowear announced today that its SimpleSense nanotechnology-enabled wearable and software platform received FDA 510(k) clearance. The AI-enabled noninvasive, cuffless, continuous blood pressure monitor and diagnostic offers a tool in the diagnostic management of hypertension. It adds to the wearable platform’s previously cleared cardiopulmonary diagnostics. The FDA cleared it as software as a medical device (SaMD). […]
FDA clears new MR scanner from Siemens Healthineers
Siemens Healthineers announced today that the FDA cleared its Magnetom Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner. Magnetom Cima.X includes the strongest-ever gradients system for a clinically released whole-body MR scanner, according to a news release. This makes smaller structures in the body visible and captures images faster than previous MR scanners. Other […]
FDA clears novel endoscopic ultrasound tech from EndoSound
EndoSound announced today that it received FDA 510(k) clearance for its EndoSound Vision System (EVS). Portland, Oregon-based EndoSound designed the EVS endoscopic ultrasound (EUS) device to attach to upper gastrointestinal endoscopes. It easily integrates to any endoscopy center’s existing ecosystem and provides access to both imaging and a therapeutic procedure. EndoSound believes the EVS could […]
Pulse Biosciences seeks FDA nod for pulsed-field ablation cardiac clamp
Pulse Biosciences (Nasdaq:PLSE) announced today that it filed for FDA 510(k) clearance for its novel CellFX nsPFA Cardiac Clamp. Hayward, California-based Pulse designed its CellFX nanosecond pulsed-field ablation (nsPFA) technology to treat AFib. The company utilized this technology with a catheter for the first time in humans last month. Pulse’s Cardiac Clamp produces continuous linear […]
J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system
Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system. While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle […]
FDA clears neurovascular aspiration, access catheters from Perfuze
Perfuze announced today that the FDA cleared its Millipede 070 aspiration catheter and second-generation Millipede 088 access catheter. Galway, Ireland-based Perfuze developed Millipede 070 to address critical unmet needs in ischemic stroke treatment. It aims to remove clots rapidly and safely through a novel, unique catheter. Millipede 070 has a unique design with a rib-and-recess […]
FDA clears Masimo Stork home baby monitoring system
The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo . Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies. Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its […]
FDA clears ZimVie and Brainlab spinal fixation combo
ZimVie announced today that the FDA has cleared the use of its Vital spinal fixation system with Brainlab’s Spine & Trauma Navigation. The news comes just nine months after the companies announced a partnership in which Brainlab will provide spine imaging, planning, navigation, and robotic-assisted systems for use with ZimVie implants. The goal is to enable […]