The U.S. Federal Trade Commission (FTC) has updated a 1998 compliance guidance for health care products, much of which reiterates the provisions of the legacy edition. However, this updated version calls for randomized, controlled clinical trials to substantiate any claims made in connection with medical devices.
It may still be true that a majority of medical devices are manufactured in the U.S., but that doesn’t stop the FDA from dropping a warning letter on facilities located outside the U.S. (OUS). In one of these warning letters, Microvention Inc., of Aliso Viejo, Calif., received a warning letter for its plant in Costa Rica, although the FDA waited until the second week of February to post the Sept. 30, 2022, warning.
Reflexion Medical Inc. has been granted U.S. FDA marketing clearance for biology-guided radiotherapy to treat early and late-stage cancers. An expansion of the company’s existing X1 platform, Scintix is indicated for patients with lung and bone tumors which may arise from primary cancers or from metastatic lesions spread from other cancers in the body.
The U.S. FDA has cleared the way for Seastar Medical Holding Corp.. to conduct a pivotal IDE study of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). The Denver-based company plans to begin enrolling patients as early as next month.
The U.S. FDA raised some hackles with its final guidance for clinical decision support (CDS) software, thanks to provisions that some stakeholders argued flew against congressional intent regarding the regulatory status of some device functions. That final guidance is now the target of a petition by the CDS Coalition to withdraw and rewrite the final guidance, arguing that the agency is “doing an end run” around the limitations established by Congress regarding the FDA’s oversight of software as a medical device (SaMD).
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.
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.
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.
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
Orthogen AG received an investigational device exemption (IDE) from the U.S. FDA for its Orthogen technology device. This approval allows the company to start a pivotal trial on the device, used for treating patients with mild stage (II) to severe stage (IV) knee osteoarthritis. The trial will compare improvements in pain levels and function using standalone glucocorticoid injection, the current standard of care, against the Orthogen device.
