LifeShirt.com software indications expanded by FDA:
This article was originally published in Clinica
Executive Summary
LifeShirt.com's R&D partner Non-Invasive Monitoring Systems has received US FDA 510(k) clearance for an expanded indication for its RespiEvents software package, which is used with LifeShirt.com's ambulatory patient monitor. The monitor, which is not yet approved in the US, resembles a shirt with embedded sensors to monitor continuously a patient's vital signs during daily activities. The new indication allows for the analysis of breathing patterns as an aid to diagnosing apnoea and hypopnoea, said LifeShirt.com of Ojai, California.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.