The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
U.S. federal law is still lacking where AI is concerned, but California’s attorney general issued a bulletin that elevates the legal hazards of AI in medical use. The bulletin says that AI tools may not supplant a physician’s decision-making, a provision that would seem to render some FDA-cleared products illegal there.
Curently the only available blood test to tell which women are at risk of postpartum depression (PPD) is the one that confirms their pregnancy – and a one in seven chance of developing the condition which can have long-term implications for both mother and child. Research out of the University of Virginia and Weill Cornell Medicine could soon change that by identifying biomarkers in the third trimester of pregnancy that indicate which women have the greatest risk of developing PPD.
Whether Robert F. Kennedy Jr. (RFK) advances in his quest to become the top health care voice in the Trump administration could come down to one vote – that of Sen. Bill Cassidy. The Louisiana doctor is one of 14 Republican members of the Senate Finance Committee, which is scheduled to vote Feb. 4 on whether to send Kennedy’s nomination as Health and Human Services secretary to the full Senate for confirmation. If all 13 Democrats on the committee vote against it, one no vote from a Republican could stop the process.
President Donald Trump’s penchant for tariffs as a negotiating tool was on full display when he slapped a 25% tariff on products coming from Mexico and Canada – which may already been suspended in the case of Mexico. The actual impact of the tariffs on med tech is nonetheless tough to gauge due in no small part to the prospect that manufacturers will simply pass on at least part of the tariff to its customers in the U.S.
Concluding a two-year journey, Baxter International Inc.’s kidney care unit finally separated from the company and started a new life as Vantive, following the closing on Jan. 31 of its $3.8 billion sale to the Carlyle Group Inc.
A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel.
In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome.
The EU has moved aggressively on legislation in recent years, with the AI Liability Directive serving as the latest example of legislation that sparked widespread opposition.
In a U.S. Senate Finance Committee confirmation hearing marked by shouted protests, outbursts of applause and tense exchanges on several issues, including ones beyond the reach of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr. (RFK) tried to present himself as someone who follows the science, not a conspiracy theorist or anti-vaxxer.