CoreLink this week announced the limited commercial release of its Oblique Lumbar Interbody Fusion (OLIF) Instrument Set. The OLIF technology is a less invasive approach to the lower lumbar spine for faster recovery times and minimized psoas disruption. “The addition of OLIF instrumentation bolsters our minimally invasive spine surgery options and builds on our robust […]
Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke
Johnson & Johnson’s Cerenovus recently announced it has launched its new stroke solutions platform that includes three devices for clot removal procedures. The three devices are designed to aid physicians in performing mechanical thrombectomy procedures. The devices include the Cerebase DA Guide Sheath, Cerenovus Large Bore Catheter and Embotrap III Revascularization Device. Get the full […]
India regulators propose medical device, IVD extensive risk classification lists
By Stewart Eisenhart, Emergo Group Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products in order to clarify regulatory pathways and requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
U.K. regulators issue new post-Brexit medical device regulatory compliance guidance
By Evangeline Loh and Ronald Boumans, Emergo Group The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain (and Northern Ireland and European Union (EU)) starting January 1, 2021. This is of course in the event of an anticipated hard Brexit. Get […]
InspireMD wins FDA approval for carotid stent system study
InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. Get the full story on our sister site, Medical Tubing + […]
Biden is getting the most money from medtech employees
Medtech company employees and their families have donated $289,533 to former Vice President Joe Biden, versus $190,570 for President Donald Trump, according to OpenSecrets.org. Check out our breakdown covering 25 of the largest companies. Medical device company employees’ preference in the U.S. presidential election appears to be clear: They’re providing more money to the Democratic […]
Dentsply Sirona names chief accounting officer
Dentsply Sirona recently announced that it appointed Ranjit Chadha as chief accounting officer, effective August 31. Chadha will be responsible for the company’s filings with the Securities and Exchange Commission. He replaces Jorge Gomez, who will become the company’s executive VP and chief financial officer. Chadha most recently served as senior VP of corporate financial […]
FDA clears Masimo oximetry device
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 […]
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