Quanterix (NSDQ:QTRX) this week said it appointed William Geist as chief operating officer, effective Nov. 16. Geist has more than 25 years of experience and most recently served as VP and general manager for Thermo Fisher Scientific’s protein and cell analysis and qPCR business units. He also held numerous sales, marketing and business development leadership roles […]
Abbott signs on to sponsor diabetes care equity effort
Abbott and the American Diabetes Association this week announced that Abbott has become the first anchor sponsor of the Health Equity Now platform. The platform addresses health disparities for people living with diabetes. The sponsorship includes a three-year, $5 million commitment to support the American Diabetes Association’s (ADA) advocacy and community-driven projects that are aimed […]
Armis Biopharma wins FDA approval for VeriFixx small bone implant
Armis Biopharma today said it received FDA approval for its VeriFixx Small Bone Implant. The implant is designed for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. VeriFixx can also make surgical corrections more accessible to patients in a shorter time to ambulation […]
Key steps for medical device manufacturers effective CAPA management
By Sarah Fitzgerald and Stewart Eisenhart, Emergo Group Ensuring adequate processes for corrective and preventative action (CAPA) management is a critical step for medical device manufacturers implementing ISO 13485:2016 or other quality management systems. However, effective CAPA management can prove a perennial challenge even to larger, more mature manufacturers. Get the full story here at […]
Intersect ENT announces changes to executive leadership team
Intersect ENT (NSDQ:XENT) this week announced it appointed Patrick Broderick as executive VP, general counsel and corporate secretary and Reyna Fernandez as chief human resource officer, effective Nov. 30. Broderick has more than 30 years of experience in leading high-performing teams and driving business and legal solutions. He most recently served as general counsel, chief compliance […]
FDA clears Allotrope StimSite
Allotrope Medical this week said it received FDA clearance for its StimSite. The device is designed to help surgeons locate and identify ureters during surgery. StimSite provides electrical stimulation to ureter smooth muscle tissue by testing ureter smooth muscle excitability. It can be used by OB/GYNs, general and colorectal surgeons with existing surgical instruments. “Whether […]
Monteris Medical wins Health Canada nod for NeuroBlate Fusion-S Software
Monteris Medical (Plymouth, Minn.) recently announced that it received Health Canada approval for its NeuroBlate Fusion-S software. The Fusion-S software display offers a visual representation of critical anatomical details to allow neurosurgeons to easily view brain structures throughout a procedure, according to the company. The software also features 3D views for an advanced graphical interface […]
Medtronic completes Medicrea acquisition
Medtronic (NYSE:MDT) today said it has completed the acquisition of Medicrea and its spinal surgery tech. The deal was announced in July when Medtronic said it would buy the France-based company for a tender offer price of €7.00 (nearly $7.84) per share for a premium of 22% over the closing price of shares on July 14, […]
How UKNI will mark medical devices placed on the market in Northern Ireland after Brexit
By Ronald Boumans, Emergo Group Based on the current course of the UK’s planned withdrawal from the European Union by the end of 2020, an examination of how medical device market entry in Northern Ireland will be impacted is due. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
Avanos Medical dips on Street-beating Q3 earnings
Avanos Medical (NYSE:AVNS) this week posted third-quarter results that beat the consensus on Wall Street. The Alpharetta, Ga.-based company reported profits of $19.3 million, or 40¢ per share, on sales of $185.7 million for the three months ended Sept. 30, 2020, for a sales growth of 8.3% compared with Q3 2019. Adjusted to exclude one-time items, […]
Orthofix soars on Street-beating Q3 results
Orthofix (NSDQ:OFIX) today posted third-quarter results that beat the consensus on Wall Street. The Lewisville, Texas-based company reported profits of $4.7 million, or 24¢ per share, on sales of $111 million for the three months ended Sept. 30, for a sales loss of -2.2% compared with Q3 2019. Adjusted to exclude one-time items, earnings per share […]