In Brief: Edap TMS S.A
This article was originally published in The Gray Sheet
Executive Summary
Edap TMS S.A: FDA approval of a premarket approval application supplement for the firm's Prostatron version 2.5 transurethral microwave thermotherapy (TUMT) device for treatment of moderate to severe benign prostatic hyperplasia obstruction is expected "in the coming weeks," Edap's Eric Simon, CEO, stated Oct. 27 at the Oppenheimer conference in New York City. The PMA supplement was filed in April. Edap's Prostatron version 2.0 was approved in May 1996 for treatment of symptomatic BPH ("The Gray Sheet" May 13, 1996, I&W-1). Edap's product pipeline also includes a compact, mobile version of the Prostatron and high-intensity focused ultrasound technology for the minimally-invasive destruction of certain types of tumors ("The Gray Sheet" May 19, I&W-3)...
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.