With yet another deadline looming for passage of spending bills for the U.S. federal budget, Congress has drafted an omnibus spending bill that would extend coverage of Medicare telehealth services. The problem with the legislation in the eyes of many stakeholders is that the Verifying Accurate Leading-edge IVCT Development (VALID) Act is not part of the package that must be passed by Dec. 23, an omission that leaves lab-developed tests (LDTs) in a nether world of regulatory ambiguity.

The U.K. is mulling over whether to recognize U.S. FDA approvals of medical devices as part of moves to accelerate the implementation of its post-Brexit regulatory system.

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.

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 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.