United States
Data recently published in The BMJ found that almost 30% of device adverse event reports filed with the US FDA are late or missing accurate date information. A relatively small number of companies account for more than half of the late reports.
President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
If medtech becomes embroiled in the EU-US trade war, access to critical and innovative medical devices will be under threat.
The US FDA is seeing more staff turnover this week, with CDRH deputy director for science Douglas Kelly announcing his departure while the agency gets a new chief counsel and chief of staff.
A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.
Democrats are raising concerns that the continuing resolution intended to fund the government for the remainder of fiscal year 2025 gives Trump too much power, though it is unclear whether the FDA would be as impacted as other agencies.
The $25,000 buyout, in addition to the early retirement program and layoffs, is intended to reduce the size of the US HHS workforce.
In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
The FDA commissioner nominee offered few details on device policy, but said he was open to funding device postmarket surveillance through user fees. He also offered some defense of staff cuts while saying he would perform his own assessment before planning any more.
The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.
The Voluntary Early Retirement Authority (VERA) plan would make many FDA employees with 20 or more years of service eligible for retirement, potentially increasing senior staff departures as the agency develops more layoff plans.
ACLA wants policymakers to see the vital role clinical labs play in delivering better health outcomes for patients and improving public health, especially in their potential for catching diseases early.
AvaSure’s new in-hospital virtual care assistant utilizes Oracle's cloud platform and NVIDIA AI software packages to improve clinical workflow by grading patients’ responses to a question format.
In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.
A recent webinar highlighted the need for manufacturers to monitor, manage, and address software vulnerabilities under FDA cybersecurity policy. Important elements include a thorough software bill of materials, coordinated vulnerability disclosure, and maintaining system security.
The device, which uses a flexible frame to ease insertion and minimize the dose of copper, is 99% effective in preventing pregnancy. Clinical trial lead David Turok said it represents “a real advance” in contraceptive options.
A new memo from the Office of Management and Budget directs federal agencies to create plans for reorganization and staff reductions to improve efficiency. While the document includes an exemption for staff working on public safety issues, it’s unclear whether that will be enough to keep FDA reviewers and inspectors on the job.
In the wake of cuts at the FDA, NIH and CMS, rare disease advocates are reminding Capitol Hill that some cuts can hinder progress, rather than eliminate waste.
Several counties in the US state of Georgia are maternity care “deserts.” Remote monitoring of high-risk pregnancies with maternal hypertension and diabetes could help improve the state’s high rate of maternal mortality, according to leading health service provider Philips.
10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.