An FDA advisory panel meeting yesterday and today may lean toward reclassifying transvaginal mesh products as Class III, the highest-risk category for medical devices, without recalling existing products.
MASSDEVICE ON CALL — Boston Scientific Corp. (NYSE:BSX) and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient.
The complaint cited mesh complications leading to body tissue erosion, a propensity to harbor infection and a tendency to migrate from the original implant site.
Lucid Inc. is planning a $28.8 million IPO designed to repay some of the company’s debt and build up its businsess.
The Rochester, N.Y.-based developer of skin cancer detection devices expects to repay a substantial portion of its existing indebtedness, including paying down its $6.1 million debt, with the proceeds from the offering, according to a filing with the Securities & Exchange Commission.
A company that began life in the pharmaceutical sector is venturing forth into devices in its quest to become a more diversified health care company.
Word is out about the identity of the corporate partner NxThera CEO Robert Paulson mentioned last week: American Medical Systems Inc. (NSDQ:AMMD).
AMS specializes in medical devices related to pelvic health. NxThera is developing a thermal vapor prostate treatment that involves the same area of the body where American Medical Systems’ expertise lies.
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.
Here’s a quick rundown of a few releases over the past couple days:
American Medical Systems Holdings Inc. (NSDQ:AMMD) posted fourth-quarter sales of $146 million for the three months ended Jan. 2, up 9 percent compared with $134 million during the same period last year. Net income rose more than 136 percent to $22.3 million, compared with $9.4 million during Q4 2008:
American Medical Systems Confirms Fourth Quarter Revenue and Finishes
2009 with Strong Financial Performance