Senseonics (NYSE:SENS) announced today that the first patient was implanted with its next-generation Eversense E3 continuous glucose monitor. Germantown, Maryland-based Senseonics, in partnership with Ascensia Diabetes Care, launched the Eversense E3 long-term implantable CGM system in the U.S. earlier this week. The system received FDA approval in February for use lasting up to six months (180 days), making […]
Implants
Analysts see Medtronic’s diabetes, spine businesses as most likely spinoff candidates
Needham analysts published a report singling out the diabetes and spine businesses as possible spinoff options for Medtronic (NYSE:MDT). Mike Matson, David Saxon and Joseph Conway of Needham pointed to previous comments from Medtronic management that indicate the potential for changes in the coming year, with a spinoff of a large business within Medtronic considered […]
Integer buys Aran Biomedical for $131.1 million
Integer (NYSE:ITGR) announced today that it acquired Connemara Biomedical and its subsidiaries Aran Biomedical and Proxy Biomedical (collectively “Aran”). Aran offers development and manufacturing solutions for implantable medical devices, including proprietary medical textiles, high-precision biomaterial coverings and coatings, and advanced metal and polymer braiding. Get the full story at our sister site, Medical Design & Outsourcing.
FDA clears antibiotic-embedded hernia mesh for fighting implant infections
Ariste Medical recently won FDA 510(k) clearance for its drug-embedded, polypropylene hernia mesh to fight microbial colonization. The Salt Lake City-based drug-device developer said the patents and proprietary formulations behind the technology could prevent infection, inflammation or clotting associated with implants. Ariste’s synthetic mesh carries two antibiotics — minocycline and rifampin — to prevent contamination […]
Bioventus plans to buy CartiHeal for at least $315M to launch knee implant
Bioventus (Nasdaq: BVS) today said it plans to buy CartiHeal following the FDA’s recent premarket approval of the Israel-based medtech developer’s Agili-C implant. Durham, North Carolina-based Bioventus will pay about $315 million to buy the company, excluding the stake already owned by Bioventus after it made a $50 million escrow payment last year. The deal also […]
FDA approves Abbott’s leadless pacemaker for patients with slow heart rhythms
Abbott (NYSE:ABT) announced today that the FDA approved its Aveir single-chamber (VR) leadless pacemaker for slow heart rhythms. In November 2021, the Abbott Park, Illinois-based company reported results from an FDA investigational device exemption (IDE) study that showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms, suggesting that, if approved, […]
Study produces ‘promising results’ for Carthera’s SonoCloud tech for mild Alzheimer’s symptoms
Carthera announced positive results from a trial evaluating the safety and efficacy of the use of its SonoCloud technology. Results from the investigator-sponsored trial of SonoCloud in patients with mild Alzheimer’s Disease (AD) were published this week in the Alzheimer’s Research & Therapy Journal. Paris-based Carthera designed SonoCloud, an implantable 1 MHz ultrasound device, to be […]
FDA approves Edwards Lifesciences’ tissue-based mitral valve replacement
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system. Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. In addition, it features a low-profile frame for avoiding obstruction of the left ventricular outflow tract […]
Synchron says study shows safety of its brain-computer interface implant
Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input. New York-based Synchron said this study demonstrated the safety of its brain-computer […]
CartiHeal wins FDA premarket approval for its Agili-C knee implant
CartiHeal announced today that it received FDA premarket approval for its Agili-C implant for treating knee joint surface lesions. Kfar Saba, Israel-based CartiHeal designed its Agili-C implant as a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints. Its PMA indication covers the treatment of an International Cartilage Repair Society (ICRS) grade III […]
FDA clears Ossio’s OssioFiber suture anchors for bone fixation
Ossio announced today that it received the third FDA clearance for its OssioFiber product family in recent months. Woburn, Massachusetts-based Ossio’s latest regulatory nod covers the OssioFiber suture anchors (4.75 mm-5.5 mm) for use in the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in a variety of […]