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American Medical Systems Holdings Inc.

Update: FDA panel may bump transvaginal mesh up to high-risk without issuing a recall

September 9, 2011 By MassDevice staff Leave a Comment

FDA

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.

Filed Under: Implants, News Well, Recalls, Women's Health Tagged With: American Medical Systems Holdings Inc., Boston Scientific, C.R. Bard, Johnson and Johnson

FDA may revoke 510(k) clearances for transvaginal mesh products

August 31, 2011 By MassDevice staff Leave a Comment

FDA

Transvaginal mesh products may have their 510(k) clearance revoked and sellers like Boston Scientific Corp. (NYSE:BSX) and Johnson & Johnson (NYSE:JNJ) may have to submit new clinical safety data in order to keep the devices on the market.

Filed Under: Food & Drug Administration (FDA), Gynecological, News Well, Recalls, Women's Health Tagged With: American Medical Systems Holdings Inc., Boston Scientific, C.R. Bard, Johnson and Johnson

BSX and AMS accused in transvaginal mesh lawsuit | MassDevice.com On Call

August 30, 2011 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Food & Drug Administration (FDA), Implants, Legal News, News Well, Recalls, Robotics, Wall Street Beat, Women's Health Tagged With: American Medical Assn., American Medical Systems Holdings Inc., Boston Scientific, C.R. Bard, Intuitive Surgical, titanmedical

Endo closes the deal with American Medical Systems for $2.9 billion in cash

June 22, 2011 By MassDevice staff Leave a Comment

Endo Pharm.
AMS

Endo Pharmaceuticals Holdings Inc. (NSDQ:ENDP), once devoted solely to the drug market, began its foray into medical devices with a successful $2.9 billion cash buyout of American Medical Systems Holdings Inc. (NSDQ:AMMD).

Filed Under: Business/Financial News, Mergers & Acquisitions, News Well Tagged With: American Medical Systems Holdings Inc., Endo Health

Hedge fund billionaire puts more skin in med-tech | Funding Roundup

June 3, 2011 By MassDevice staff Leave a Comment

Funding

Mario Gabelli, one of the world’s wealthiest men, put another $3.4 million into Orthovita Inc. (NSDQ:VITA) and dropped $25 million on American Medical Systems Holdings Inc. (NSDQ:AMMD).

Filed Under: News Well Tagged With: American Medical Systems Holdings Inc., Cardiovascular Systems Inc., Gamco Investors Inc., Lumicell, Orthovita Inc., Stryker, Venture Capital/Private Equity

Patent infringement plaintiffs rejoice: Appeals court raises the bar for inequitable conduct | Legal News

June 3, 2011 By MassDevice staff Leave a Comment

Abbott
Becton, Dickinson

A federal appeals court made it harder for defendants in patent infringement cases to use an "atomic bomb" defense tactic called inequitable conduct in a lawsuit between an Abbott (NYSE:ABT) subsidiary and Becton, Dickinson & Co. (NYSE:BDX).

Filed Under: Legal News, News Well, Patent Infringement Tagged With: Abbott, American Medical Systems Holdings Inc., becton dickinson, Greenberg Traurig, Histogen Inc., SkinMedica, Therasense

Skin cancer detection firm Lucid readies $29 million IPO | Funding roundup

April 19, 2011 By MassDevice staff Leave a Comment

Funding Roundup

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.

Filed Under: News Well Tagged With: American Medical Systems Holdings Inc., Lucid Inc., SANUWAVE Health Inc., Silk Road Medical Inc., Spherix Inc.

Endo targets American Medical Systems for $2.9 billion | Acquisitions roundup

April 12, 2011 By MassDevice staff Leave a Comment

M and A Roundup

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.

Filed Under: Mergers & Acquisitions, News Well Tagged With: American Medical Systems Holdings Inc., CareFusion Corp., CryoLife, Endo Health, Laboratory Corp. of America Holdings, Rochester Medical Corp., Shrink Nanotechnologies Inc.

NxThera’s mystery backer is American Medical Systems

March 17, 2011 By MedCity News Leave a Comment

NxThera, AMMD

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.

Filed Under: News Well Tagged With: American Medical Systems Holdings Inc., NxThera Inc., Venture Capital/Private Equity

Insulet’s Q4 losses widen but 2010 losses fall 16 percent | Earnings roundup

February 16, 2011 By MassDevice staff Leave a Comment

MassDevice.com Earnings Roundup

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:

Filed Under: Business/Financial News, MassDevice Earnings Roundup, News Well Tagged With: AdvanSource Biomaterials Corp., American Medical Systems Holdings Inc., ArthroCare Corp., Corgenix Medical Corp., DJO Global, Dynatronics Corp, Exact Sciences Corp., Gen-Probe Inc., Insulet, IsoRay, Masimo, Orthofix, Q4, Theragenics Corp., Unilife Corp.

American Medical Systems’ Q4 sales rise, earnings soar 136 percent

February 17, 2010 By MassDevice staff Leave a Comment

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:

Press Release

American Medical Systems Confirms Fourth Quarter Revenue and Finishes
2009 with Strong Financial Performance

Filed Under: Business/Financial News, MassDevice Earnings Roundup, News Well, Urology Tagged With: American Medical Systems Holdings Inc.

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