The U.S. FDA has updated its data on the number of fatalities across globe associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now reach 59 fatalities. That number is up from 33 reported in July 2019 but is also a number the agency continues to assert may be a significant undercount.

The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).

The U.S. Senate and House of Representatives have not yet come to terms on FDA user fee legislation, a quinquennial source of melodrama that leaves the agency in an awkward position with current employees. However, FDA principal deputy commissioner Janet Woodcock said recently that prospective employees are also watching how Congress handles its business, adding that some of these pending hires may take jobs elsewhere rather than wait on Congress to send a user fee bill to the White House.

Now that the U.S. Department of Health and Human Services (HHS) has declared monkeypox a public health emergency, nearly two weeks after a similar declaration from the World Health Organization, the way is cleared for a coordinated response and emergency use authorizations to address supply challenges that could limit the availability of currently approved vaccines. It also has several companies ready to leap into the fray if their preclinical studies show a path to approval. HHS said it just shipped more than 602,000 doses of the Jynneos vaccine to states and jurisdictions, an increase of 266,000 in the past week.

The FDA’s ability, or lack thereof, to churn out guidances is not always the stuff of industrial outrage, but manufacturers of laser-assisted in situ keratomileusis (LASIK) systems might find the timing of a new draft guidance on the procedure somewhat odd. The draft guidance arrives nearly a decade and a half after an April 2008 advisory hearing.

The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.

The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.