Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor.

Paragonix Technologies Inc. expanded access to its U.S. FDA-cleared Baroguard donor lung preservation system following a successful limited release with a handful of top transplant centers. In addition to critical temperature control, the new system provides active airway management to keep donor lungs in the best condition possible.

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.

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.

Asensus Surgical Inc. grabbed a $10 million lifeline from prospective suitor Karl Storz SE & Co. KG, which has offered to buy the cash-strapped company for 35 cents per share or about $96 million. Asensus signed a non-binding letter of intent to consider and negotiate terms after “an extensive period of consideration of various strategic alternatives.” Under certain circumstances, it could access a further $10 million from Storz prior to a merger. Asensus reported in March that its cash runway would tap out in early July.

Angiodynamics Inc. said it has settled with the parent company of C.R. Bard Inc., over a series of conflicts over patents held by Bard that will cost Angiodynamics nearly $10 million just in 2024, potentially significantly more.