The U.S. FDA’s surveillance of duodenoscopes and other endoscopes was initially driven by concerns about device sterility, but recent inspections of manufacturing sites operated by Olympus Medical Systems Corp., in Japan have fed warning letters for lapses from various regulations. In the latest warning letter, the agency cited one of the company’s sites in Tokyo for both quality system and medical device reporting lapses, the second warning letter issued to the company in roughly three months.
Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Woven Orthopedic Technologies LLC, received U.S. FDA 510(k) clearance for its Ogmend implant enhancement system for use in spine surgery. Ogmend is expected to give surgeons more confidence in using surgical screws when operating in compromised fixation scenarios.
The U.S. FDA reported that Baxter International Inc. issued an Urgent Medical Device Correction for its Life2000 ventilation systems in response to reports of potential patient oxygen desaturation events when connected to a third-party oxygen concentrator.
Vivasure Medical Ltd. received a €30 million (US$32 million) strategic investment from Haemonetics Corp. to help develop its Perqseal closure device system which manages bleeding complications associated with large-bore arterial vessel closure. Haemonetics has an option to buy Vivasure upon the completion of the company achieving certain milestones.
The Biden administration released a blueprint for the U.S. federal government’s fiscal 2024 budget year on March 9, which includes additional funding for pandemic preparedness. However, the White House has signaled its intent to drill down on drug prices with an increase in the scope of the number of drugs subject to Medicare price negotiations along with a 67% increase in the Advanced Research Projects Agency–Health (ARPA-H) to $2.5 billion, a boost that is sure to draw cheers from companies in the life sciences.
The FDA’s emergency use authorization (EUA) program for rapid antigen tests for the COVID-19 pandemic is coming to an end, but few rapid antigen test makers have laid out clear plans regarding the post-public health emergency world. Quidelortho Corp. managed to beat the competition to the non-EUA market for these tests with a grant of de novo petition for its Sofia rapid antigen test, which now provides other tests with a predicate device, thus ensuring that this will not be the last such test to reach the U.S. market.
The FDA’s device center just released three performance reports related to the fourth and fifth device user fee agreements, including a financial report that shows the agency collected far more in user fees than it spent for fiscal year 2022, yielding a carryover amount of more than $142 million. One of the more interesting aspects of the report is that because the taxpayer dollars used for FDA’s device inspections did not meet a pre-specified amount for two consecutive years, third-party inspections for FDA compliance purposes have been disallowed for fiscal year 2023, making hash of a program sought by domestic manufacturers who distribute their products to other nations as well as in the U.S.
The U.S. FDA granted Sooma Oy breakthrough device designation for its patient-administered neuromodulation device to treat depression. Sooma Depression Therapy uses a mild electrical current to stimulate targeted brain areas, resulting in a significant improvement in depressive symptoms.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
