The conviction and sentencing of Elizabeth Holmes and Sunny Balwani of Theranos Corp. might be seen as an example of retribution for testing technology that didn’t exist and thus endangered patients, but that perception doesn’t stand up to scrutiny.
The U.S. Department of Justice (DOJ) has developed a number of policies related to corporate misconduct over the past couple of decades, some of which were stood up only to be reversed a short time later.
Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing of units and parts is proceeding at the maximum pace allowed by supply chain volatility and recommended that hospitals facing shortages contact other nearby hospitals in the event of a lack of device availability.
The U.S. FDA reported that the post-approval study (PAS) for the Impella RP by Abiomed Inc. of Danvers, Mass., demonstrated that the device performed well for patients who would have been eligible for the pivotal study, providing a 69.7% survival rate at 30 days after device explant.
The ability to inexpensively predict events such as stroke and heart attack is something of a holy grail for cardiologists, and a new study presented at this year’s annual meeting of the Radiological Society of North American (RSNA) provides just that capability. A study of an algorithm developed to examine a single chest X-ray suggests that the data generated by the algorithm can be as effective in establishing the patient’s risk of these events as a standard approach that relies on information that isn’t always readily available to the clinician.
The U.S. Federal Trade Commission (FTC) has moved decisively in the area of mergers and acquisitions recently, but the agency also has a footprint in the enforcement space for health data disclosure. The FTC’s Ronnie Solomon said in a Dec. 1 public meeting that the agency will begin “thinking outside the box about what health information is in the 21st Century,” adding that the FTC is eyeing a more stringent enforcement regime regarding personal health data disclosures in the coming new year.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product.
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
The U.K. National Institute for Health and Care Excellence has expanded its endorsement for the Greenlight XPS system for benign prostatic hyperplasia to no longer exclude patients deemed at high risk for hemorrhage, a decision that may boost utilization and thus sales of the XPS.
U.S. Supreme Court case law on patent subject matter eligibility has provoked several attempts by Congress to rewrite the statute, but there are lingering concerns about the latest proposal, the Patent Eligibility Restoration Act of 2022. Among these concerns is that the revised set of exceptions to subject matter eligibility might take time to work through both in terms of litigation and patent prosecution, but the bill has the support of a number of stakeholders, including two former commissioners of the U.S. Patent and Trademark Office (PTO).