Device recalls pop up with no regard to human appreciation for seasonality, and thus it was that recalls involving three major medical device makers emerged as the steamy month of July gave way to the arid, oppressive swelter of August. These recalls affected more than 7,500 units of the Trusignal pulse oximeter by GE Healthcare Technologies Inc., nearly 23,000 units of the Sigma Spectrum and Spectrum IQ infusion pumps by Baxter Healthcare Corp., and an unspecified number of units of the Carina ventilator by Drägerwerk AG, all of which adds a little more than the usual heat to the device industry’s dog days.
The U.S. FDA unveiled a proposal to once again reshuffle its operations, this time with a greater degree of emphasis on the function of the Office of Regulatory Affairs (ORA). Tim Philips, a consultant with Gardner Law and a former member of the FDA, told BioWorld that while these changes will likely yield some useful efficiencies, they might also dilute some of the more useful interaction between industry and FDA, a loss that may be keenly felt when it comes to matters such as FDA inspections.
The U.S. Army needed 10 months to award a contract following a July 2022 request for proposals for flow cytometry and other clinical lab equipment, but Beckman Coulter Inc., filed an appeal that protested the award to Sysmex America Inc., of Lincolnshire, Ill. Beckman Coulter argued that Sysmex should have been disqualified from the bidding for failing to provide a technically acceptable proposal, but the Government Accountability Office decreed that the company’s protest failed because it was not filed within the required 10 days post-award.
The U.S. Security and Exchange Commission’s final rule for disclosure of cybersecurity incidents would seem to weigh more heavily on device makers and their client hospitals than on other industries, particularly given that the draft rule required a four-day notification of any such events. The final rule retains that requirement to notify investors of any such breach within four days, although the SEC relented on the content of such disclosures to ease concerns about the potential for disclosures to amplify the cybersecurity threat.
Cardiologists have debated for some time whether obstructive sleep apnea (OSA) is a proven factor in a patient’s risk for heart disease, but the U.S. National Institutes of Health says newly published studies identify the specific mechanisms for this association. The studies offered data from more than 4,500 subjects and affirms the notion that OSA-driven hypoxia correlates well with the occurrence of a primary cardiovascular event, but the NIH says these findings need to be confirmed in another trial, hopefully one with enrollees whose OSA is deemed a high-risk version of the condition.
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
The U.S. FDA has issued a draft guidance for devices intended to address opioid use disorder (OUD), a problem with a massive public health footprint that has defied the efforts of public health programs. The draft guidance highlights some of the difficulties in executing pivotal studies for these devices, but the FDA’s July 27 press omits any mention of a 2018 innovation challenge for this category of devices, a programmatic effort that seems to have yielded little in the way of tangible results.
The U.S. Federal Trade Commission (FTC) has been exceptionally active in the mergers and acquisitions space for the past 18 months, but Congress might soon amplify these agencies’ ability to suppress these transactions. Sen. Amy Klobuchar (D-Minn.), who chairs the competition subcommittee of the Senate Judiciary Committee, said in a recent hearing that vertical mergers have flown largely off the enforcement radar, a problem that Congress could address by several means, including by providing the FTC with a heftier budget to pursue these cases.
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
The U.S. Senate held a July 25 hearing on the need for regulation of artificial intelligence (AI), which highlighted an interest in a single overarching agency that would direct any regulations promulgated for AI across the U.S. economy.
