SPY420.86+5.94 1.43%
DIA338.78+5.82 1.75%
IXIC14,141.48+111.10 0.79%

MedTech Round Up: Update On Products By Conformis, Medtronic, Orthofix, Neovasc

The FDA has given 510(k) clearance for Conformis Inc's (NASDAQ: 

05/10/2021 13:35

The FDA has given 510(k) clearance for Conformis Inc's (NASDAQ: CFMS) Identity Imprint Knee Replacement System, available in both cruciate-retaining (CR) and posterior stabilized (PS) versions.

  • Identity Imprint utilizes a proprietary 3-dimensional "best-fit" algorithm to select the implant that most closely meets the geometric and anatomic requirements of the patient based on the patient's computed tomography scans.
  • Price Action: CFMS shares are trading 6.95% higher at $0.90 during the market trading session on the last check Monday.

Medtronic plc (NYSE: MDT) has announced the U.S. commercial launch of the SonarMed airway monitoring system, a pediatric monitor to check endotracheal tube (ETT) obstruction and verify position in real-time.

  • SonarMed, which Medtronic acquired in December 2020, specializes in developing solutions that increase patient safety while significantly decreasing healthcare costs.
  • Price Action: MDT shares are up 0.43% at $127.24 during the market trading session on the last check Monday.

The FDA has given 510(k) clearance to Orthofix Medical Inc's (NASDAQ: OFIX) OrthoNext digital platform, a software tool for deformity analysis and preoperative planning for pediatric orthopedic procedures.

  • Developed specifically for use with the JuniOrtho Plating System, the OrthoNext digital platform software enables the surgeon to plan the osteotomy position accurately to visualize the implant concerning the anatomy.
  • The company has initiated its U.S. and European full market launch of the JuniOrtho Plating System.
  • Price Action: OFIX shares are down 4.05% at $42.37 during the market trading session on the last check Monday.

Neovasc Inc (NASDAQ: NVCN) has enrolled the first patient in the COSIMA trial investigating the company's Reducer for the treatment of Microvascular Angina.

  • The study will enroll up to 144 patients across multiple centers in Germany. The primary endpoint of the study is the change in CCS angina class, a measure of chest pain severity and limitation, by two or more classes.
  • The Reducer is CE-marked in the European Union to treat refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle.
  • Price Action: NVCN shares are down 3.2% at $0.83 during the market trading session on the last check Monday.

See Benzinga's FDA Calendar