Patients with ophthalmic disease use eyedrop containers and eyecups millions of times a year, but these two devices have been treated as one device type and informally regulated as class II devices up to now. A U.S. FDA advisory committee recommended a class I designation for these products, which will relieve some of the burden on manufacturers, but the panel also endorsed that these two types of products be split into two separate product codes, which would greatly facilitate adverse event reporting.

The U.S. FDA has wrapped up its guidance effort to deal with counterfeit devices, an effort that consumed roughly 11 months. That span of time had little discernible effect on the draft, however, as the final guidance seems to leave the draft’s explanation that future FDA guidances may refer to more than one section of the statute in references to the definition of a device.

Med tech firms are becoming quite familiar with the world of digital health in recent years, but this has often been a pairing of strange bedfellows at best up to now. A new report by Accenture on industry adoption of digital health lays out some of the reasons for that, but some impediments come from government, such as the lag in development of regulatory policies for artificial intelligence (AI) and software as a medical device (SaMD).

The U.S. FDA recently convened an advisory committee to address accuracy issues with pulse oximetry devices, with a significant focus on skin pigmentation as a source of noise in the results generated by these class II devices. However, a number of other factors, including obesity and finger size/diameter, also cloud the values generated by pulse oximeters, all of which combine into a large set of variables that premarket studies may have to address before the FDA will issue new marketing authorizations.

Few disease states in the world of cardiology have been studied as persistently as atrial fibrillation (AF), but new study data presented in Chicago at the 2022 scientific sessions of the American Heart Association seem to advance the cause of an ablation-first strategy for some patients experiencing paroxysmal AF. The PROGRESSIVE-AF study demonstrated that patients who are ablated early in the disease cycle are less likely than those placed on drug management to experience recurrence and to be readmitted, just two of several findings that are driving cardiologists toward device therapy and away from drug therapy for their patients with AF.

Teleflex Inc. issued a recall of its Iso-Gard S filters for respiratory equipment due to reports of separation, a problem that could impede the delivery of oxygen to patients. The class I recall was driven by 36 complaints and four injuries reported to the U.S. FDA, and affects more than 60,000 units shipped between Sept. 1, 2020, and July 5, 2022.