The FDA advisory hearing for the Transmedics Organ Care System (OCS) resulted in a unanimous vote in favor of the OCS’s safety and efficacy numbers, although there will be a considerable post-approval study requirement. The company was able to overcome a number of problems with the pivotal study that might otherwise have tanked the application, such as the lack of blinding of transplant surgeons, which the FDA said could have biased the determination of whether a liver was acceptable for transplant.

The FDA is working toward a rewrite of its Quality Systems Regulation (QSR) and ISO 13485, the internationally recognized quality management standard, but that project has yet to produce a draft rule despite several years of effort. The FDA’s Vidya Gopal highlighted the differences between the two approaches to questions such as management responsibility and staff resources, just two of many differences that will prove difficult to reconcile in any regulatory harmonization effort.

The U.S. Federal Trade Commission (FTC) had previously reported it would more tightly scrutinize mergers and acquisitions with an eye toward the impact on competition, and voted July 21 to expand its authority to review these activities. The agency also voted to eliminate restrictions by original equipment manufacturers (OEMs) on servicing of their devices, thus putting both drug and device makers on alert that much more rigorous FTC enforcement has arrived.

The medical device development tool (MDDT) may come across as so much regulatory esoterica of little utility to most device makers, but that perspective might be unduly pessimistic. The FDA’s Edward Margerrison, director of the Office of Science and Engineering Laboratories, said the agency is intent on making MDDTs as ordinary as possible to allow device makers to do what they do best, which is to focus on making the best device they can.

The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices.

Fibromyalgia is an often debilitating condition, characterized by chronic pain throughout the body that can leave patients fatigued, depressed and unable to perform even the simplest of activities. While a handful of drugs have been approved to treat this autoimmune disorder, they can have unpleasant side effects and do not benefit all patients. To that end, the FDA has granted a breakthrough device designation to Neurometrix Inc.’s Quell wearable neurostimulation device for treating the symptoms of fibromyalgia in adults.

Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.

Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.”

Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.