Sema4 Holdings Corp., Illumina Inc. and Pear Therapeutics Inc. joined a growing list of med-tech companies responding to what Pear CEO Corey McCann called a “challenging macroenvironment” by spinning off, selling or shuttering non-core lines of business and slimming payroll.
The U.S. FDA has given the green light to Aeye Health Inc. for its autonomous diagnostic screening system for diabetic retinopathy. The Aeye Diagnostic Screening (Aeye-DS) uses artificial intelligence (AI) to diagnose the eye condition from retinal images captured by a fundus, or retinal, camera.
Cybersecurity has become one of the core concerns for med tech in this part of the 21st Century, and a collaboration between the FDA and the Mitre Corp., has yielded a new playbook that calls for a regional response to issues such as ransomware. However, this new document calls on medical device manufacturers to take part in cybersecurity exercises along with health care delivery organizations, an exercise that some manufacturers might not be prepared to undertake.
The U.S. Department of Health and Human Services (HHS) has issued a bulletin in connection with the Venus ransomware, the latest in a running series of such malware to hit computer systems across the globe.
Acotec Scientific Holdings Ltd. obtained marketing approval from the U.S. FDA for its peripheral support catheter Vericor, designed to enhance access to peripheral vessels.
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.
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.
Election day has come and gone in the U.S., but the question of which party will control Congress remains unanswered, signaling that the country is as divided as ever politically and ideologically. While Democrats and Republicans may agree on problems in the life sciences sector, they often disagree on how to address them.
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.
The American College of Cardiology and the American Heart Association (AHA) released new guidelines for the diagnosis and management of aortic disease just ahead of this year’s AHA Scientific Sessions, which start Nov. 5 in Chicago. The update is the first comprehensive revision to the guidelines since 2010. Key recommendations address screening and diagnostic testing, imaging, patient involvement in care decisions and when to consider surgery.
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