Masimo this week announced that its O3 Regional Oximetry received expanded FDA clearance. The expanded use covers monitoring somatic tissue oxygenation saturation in all patient populations and monitoring relative changes in hemoglobin, oxyhemoglobin and deoxyhemoglobin in adult brains. O3 is also now indicated for use in both cerebral and somatic applications. The oximetry device uses […]
DJO launches two new Empowr orthopedic systems
DJO this week said it has launched its new Empowr Acetabular and Empowr Partial Knee systems. Both systems give surgeons a comprehensive and efficient solution for all total hip arthroplasty and unicompartmental knee arthroplasty approaches and settings, according to the company. “We are building on the proven success, deep clinical research, and differentiated design technologies […]
Understanding clinical evidence requirements under European Medical Devices Regulation
By Dietmar Falke, Emergo Group The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing […]
Centinel Spine appoints new chief financial officer
Centinel Spine this week said it appointed Varun Gandhi as chief financial officer, effective August 17. Gandhi succeeds Jeff Stello, who had served as interim chief financial officer since late 2018. Prior to his appointment, Gandhi served as senior VP of corporate finance and strategic planning and GM of international at Centinel Spine. He previously […]
Deep Blue Medical launches hernia mesh line
Deep Blue Medical this week announced that it has received FDA clearance for its T-Line Hernia Mesh. The T-Line Hernia Mesh offers superior anchoring strength and eliminates a key point of failure for conventional mesh fixation, which is the mesh, suture, tissue interface that can lead to mesh migration, contraction and failure. Deep Blue’s hernia […]
Medtronic to acquire Companion Medical, expands diabetes business
Medtronic (NYSE:MDT) today said it would acquire insulin pen manufacturer Companion Medical for an undisclosed amount. Companion Medical’s product portfolio includes the InPen FDA-cleared smart insulin pen system that is paired with an integrated diabetes management app on the market. It is designed to help calculate insulin doses, track active insulin and send reports to caregivers […]
Olympus to acquire Arc Medical Design
Olympus (TYO:7733) recently announced that it has signed a definitive agreement to acquire Arc Medical Design for an undisclosed amount. Through the agreement, Olympus will acquire the company and obtain full rights to its suite of innovative medical products. It will convert its exclusive distribution rights of Endocuff Vision to a full acquisition of the product […]
ICU Medical shares rise on Street-beating Q2 results
ICU Medical (NSDQ:ICUI) posted second-quarter results that beat the consensus forecast on Wall Street. The San Clemente, Calif.-based company reported profits of $18.9 million, or 88¢ per share, on sales of $303.4 million for the three months ended June 30, for a bottom-line loss of -17.2% sales loss of -2.8% compared with Q2 2019. Earnings per […]
Organogenesis up 10% on Street-beating Q2 results
Organogenesis (NSDQ:ORGO) posted second-quarter results this week that beat the consensus on Wall Street. The Canton, Mass.-based company reported losses of $5.2 million, or -5¢ per share, on sales of $68.9 million for the three months ended June 30, for a bottom-line loss of -46.5% sales growth of 6.2% compared with Q2 2019. Earnings per share […]
Cutera appoints new CFO
Cutera (NSDQ:CUTR) recently announced that it appointed Rohan Seth as chief financial officer, effective August 10. Seth most recently served as the VP of finance for the global orthopedic franchise at Smith & Nephew. He has also held a number of leadership roles at Alcon Labs, Stryker and Whirlpool. Seth replaces Fuad Ahmad, who has served […]
AtriCure names Angie Wirick as chief financial officer
AtriCure (NASDAQ:ATRC) recently announced that it has appointed Angie Wirick as chief financial officer, effective August 6. Wirick, who was VP of finance, replaces Andy Wade who is stepping down for personal reasons and will continue to serve in an advisory role through March 5, 2021. “On behalf of our team at AtriCure and our Board […]