Venus Concept Inc. is undergoing a bit of nip and tuck in efforts to improve the company’s cash flow position and obtain long-term stability. As part of the reconfiguration, the company plans to shed 18% of its workforce with layoffs starting on Feb. 6. In Israel and North America. The executive leadership team also experienced some plumping and extraction. Read More
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery. Read More
The Medical Device Innovation Consortium (MDIC) has played a key role in fostering a stronger industrial appreciation for the need for robust cybersecurity, but a recent MDIC report noted that many device makers are deficient in pushing cybersecurity considerations into the domain of design controls. However, the most critical element in cybersecurity may be whether a company has a chief product security officer (CPSO), the presence of absence of which seems to correlate strongly and uniformly with all aspects of cybersecurity in a manufacturer’s products. Read More
The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arima, Avania, Carestream, Cytek, Imperative Care, Kandu Health, Nec, Maxis, Newtopia, Medtronic Canada, Pierian, Rhythm Management Group. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dia Imaging Analysis, Northeast Scientific, Vero Biotech. Read More
