> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-2/
- Published: 2020-01-20T12:00:00.000Z
- Updated: 2026-09-14T15:59:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137488

**DEVICES**

FDA has cleared a **Nanowear** 510(k) for its SimplECG, a remote cardiac monitoring undergarment. The device collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a Web-based portal for review by a physician through a mobile application.

FDA has cleared a **BrightWater Medical** 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which prevent urine in the kidneys from draining to the bladder. The device is implanted once and converts from a catheter to a stent in an office procedure without the need for radiation or sedation, in less than one minute, the company says. It then remains implanted in the patient like a standard internal ureteral stent.

FDA has cleared a **Toshiba Medical** 510(k) for the Forward Projected Model-based Iterative Reconstruction Solution (FIRST) that is intended to improve high contrast spatial resolution while reducing radiation dose up to 85% as compared to filtered back projection computed tomography imaging. “FIRST can improve high-contrast spatial resolution by up to 129% (2.29 times) as compared to filtered back projection for body imaging while reducing radiation dose,” the company says.

**DRUGS**

FDA has approved a new indication for **Eli Lilly**’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and cardiovascular disease. The approval is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control.

FDA has approved a **Lupin Ltd.** ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg — generic versions of **Cephalon**’s Nuvigil, indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder. Brand sales are over $500 million annually.