BioSig Technologies today announced it appointed Anthony Amato as CEO, effective immediately. Amato will serve on the company’s board of directors, which is currently being assembled. He joins the company from consulting firm Bridge Associates International Pharmaceutical Consulting (BAIPC). Westport, Connecticut-based BioSig Technologies announced earlier this month that the company engaged with BAIPC as a […]
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Senseonics wins integrated CGM designation from FDA, can work with insulin pumps
The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS). With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future […]
Medtronic plans job cuts in California
Medtronic is eliminating 44 jobs in Carslbad, California, according to a mass layoff notice filed with the state. The permanent job cuts take effect starting on or around May 19 at 2101 Faraday Ave., Medtronic told the California Employment Development Department. FDA records list that address as a facility for Nellcor Puritan Bennett Corp., a […]
LivaNova names former J&J MedTech exec as chief innovation officer
LivaNova today announced it appointed Ahmet Tezel as chief innovation officer, effective May 13, 2024. Tezel will take on the newly created chief innovation officer position to establish an integrated innovation function at the company and accelerate the development of new technologies. “I am very pleased to welcome Ahmet to the LivaNova team. At […]
Medline enters deal to acquire Ecolab’s global surgical solutions business
Medline today announced it entered into a definitive agreement to acquire Ecolab’s global surgical solutions business. Upon closure of the deal, the acquisition will give Medline access to Ecolab’s Microtek product lines, sterile drape solutions for surgeons, patients and operating room equipment and Ecolab’s fluid temperature management system. The company said it wants to “build […]
Axogen announces first surgical implant of Avive+ Soft Tissue Matrix
Axogen (Nasdaq:AXGN) this week announced the first surgical implantation of its Avive+ Soft Tissue Matrix. Avive+ is a resorbable, multi-layer, placenta-based allograft that provides temporary protection and tissue separation during the critical phase of nerve healing. The soft tissue matrix is processed and distributed as a 361 tissue product in accordance with FDA Good Tissue Practices […]
FDA clears Route 92 Medical’s FreeClimb 54 reperfusion system
Route 92 Medical today announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system. The FreeClimb54 system uses an aspiration catheter of the same name paired with a Tenzing 5 delivery catheter. The new system is part of the company’s growing portfolio of neurovascular devices designed to work as complete endovascular thrombectomy solutions […]
Former ZimVie exec Rebecca Whitney named CEO of Highridge Medical
Highridge Medical this week announced it appointed Rebecca Whitney as CEO, effective immediately. Whitney will join the company’s board of directors as part of the appointment. Former CEO Glen Kashuba will transition to CEO of EBI. Highridge Medical and EBI are portfolio companies of HIG Capital, which earlier this month acquired ZimVie’s spine and EBI […]
Hologic to acquire Endomagnetics in $310M deal
Hologic is set to acquire breast surgical guidance company Endomagnetics for $310 million. Endomag develops and sells breast surgery localization and lymphatic tracing technology. It makes products like the Magseed marker for magnetic tissue localization before surgery. It also develops the Magtrace lymphatic tracing injectable for breast cancer staging and the Sentimag platform that supports […]
Artivion has positive heart valve data
Artivion (NYSE:AORT) today announced positive outcomes from a post-market study of its On-X aortic heart valve. The company shared five-year real-world safety and efficacy data demonstrating even better outcomes than predicted by a previous study. Other data highlighted positive aortic remodeling outcomes as well and zero distal anastomotic new entry (DANE) tears. Artivion’s five-year study […]
ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory
ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory. It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January. The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator […]