Supira Medical announced today that it initiated the first-in-human clinical study of its percutaneous ventricular assist device (pVAD). Los Gatos, California-based Supira, a Shifamed portfolio company, is using the pVAD in a prospective, single-arm, single-center study. It will evaluate the safety and performance of the low-profile, high-flow pVAD. Can Supira’s pVAD support cardiovascular hemodynamics in […]
Featured
Align Technology opens first regional manufacturing facility in Europe
Align Technology (Nasdaq:ALGN) announced that it opened its first Europe, Middle East & Africa (EMEA) manufacturing facility. The regional facility opened in Wroclaw, Poland. It represents Align’s third regional manufacturing facility globally, joining the existing ones in Juarez, Mexico, and Ziyang, China. Align said in a news release that the state-of-the-art facility will serve as […]
Three-way merger forms pulsed electric field therapy company Galvanize Therapeutics
Galvanize Therapeutics today announced a three-way merger and $100 million in funding for its pulsed electric field (PEF) technology. Life sciences venture capital firm Apple Tree Partners (ATP) created and incubated Galvanize. Initially, three companies — Gala Therapeutics, Galaxy Medical and Galvanize — comprised the incubation. They recently merged into one firm under the Galvanize […]
Edwards wins FDA approval for Pascal Precision transcatheter valve repair system
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Pascal Precision system for patients with degenerative mitral regurgitation (DMR). The implant and transcatheter delivery system represent Edwards’ bid to compete with Abbott and its MitraClip in the DMR treatment space. Irvine, California-based Edwards Lifesciences designed its Pascal Precision system for precision transcatheter edge-to-edge repair […]
Study backs FEMSelect meshless pelvic floor fixation system
FEMSelect announced positive results from a four-year prospective follow-up evaluation of its EnPlace system. Newark, Delaware-based FEMSelect designed its EnPlace system as a minimally invasive, meshless approach to pelvic floor ligament fixation. The device attaches sutures to ligaments of the pelvic floor. It represents an alternative to heavily scrutinized pelvic mesh devices. Medical investigators found […]
J&J announces $5B share repurchase
Johnson & Johnson (NYSE: JNJ) announced today that its board has authorized a $5 billion repurchase of its common stock. “The last few years have demonstrated the resilience of Johnson & Johnson. With continued confidence in our business and pipeline, the board of directors and management team believe that company shares are an attractive investment […]
Augmedics founder leaves company
More than eight years after founding Augmedics, Nissan Elimelech is leaving the developer of augmented reality surgical guidance systems. Elimelech stepped down from the corner office in January to make way for former Bardy Diagnostics CEO Kevin Hykes. Elimelech stayed on in a chief product officer role. But in a LinkedIn post today, Elimelech said: […]
Philip Morris hires two former FDA officials as it pushes ‘smoke-free’ development
Cigarette maker Philip Morris (NYSE:PM) announced today that it appointed two former FDA officials to leadership positions. Dr. Badrul Chowdhury is the company’s new chief life sciences officer for smoke-free products. Dr. Matthew Holman joins as VP of U.S. scientific engagement and regulatory strategy. Both appointments fall in line with the company’s efforts to push […]
Baxter is reportedly considering a sale of its kidney care businesses
Baxter (NYSE:BAX) is reportedly weighing the divestiture of its renal care services and hemodialysis business. According to a Bloomberg report, the company is considering splitting with its kidney care businesses as part of a refocusing effort after its $12.5 billion acquisition of Hillrom last year. The outlet cited anonymous sources familiar with the matter. The […]
Smith+Nephew announces positive data in Regeneten bioinductive implant study
Smith+Nephew (NYSE:SNN) announced today that data supports the use of its Regeneten bioinductive implant in rotator cuff repair. London-based Smith+Nephew designed Regeneten to provide a patient-centric treatment supporting the body’s natural healing process. The aim is for the implant to change the course of tear progression, aid return to normal activity and reduce re-tears compared […]
Virtuoso Surgical announces $20M offering for endoscopic surgical robot
Virtuoso Surgical announced today that its $20 million stock offering became effective after review by the U.S. SEC. Nashville, Tennessee–based Virtuoso develops a surgical robot system for minimally invasive endoscopic surgery. Its founders developed its patented technology at Johns Hopkins University and Vanderbilt University. In addition, the National Science Foundation and the National Institutes of […]