The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer.
Australia’s Competition and Consumer Commission said it will not oppose Cochlear Ltd.’s proposed acquisition of the cochlear implants business of Denmark’s Oticon A/S after the bone conduction businesses was removed from the deal.
Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the Republican leadership of the House Energy and Commerce Committee sent to the Government Accountability Office in which it asked the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.”
Makers of medical devices already have a substantial series of requirements related to cybersecurity, but those requirements may increase per a draft rule released by the U.S. Cybersecurity and Infrastructure Security Agency.
South Korean medical software firm Coreline Soft Co. Ltd. said it gained U.S. FDA 510(k) clearance for its artificial intelligence-based coronary artery calcification assessing solution, Aview CAC, while raising ₩18 billion (US$13.33 million) in a private placement.
Artificial intelligence (AI) is steadily making inroads into the world of health care, and San Francisco-based Eko Health Inc. has taken up the AI call with a stethoscope developed in conjunction with the Mayo Clinic that can detect low ejection fraction of the heart.
The U.K. Medicines and Health Care Products Regulatory Agency is in the thick of its proposed regulatory overhaul for medical technology, which the agency promises will hew closely to the regulations still in deployment in the European Union.
Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
The U.S. biopharma and med-tech industries are adding their voice to that of Gilead Sciences Inc. in urging the California Supreme Court to review the Gilead Tenofovir Cases, which seek to hold the drug company liable for how and when it developed its pipeline of HIV drugs.