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ReGen Biologics Inc.

ReGen Biologics wins round in battle with the FDA over its MenaFlex knee implant | Medtech legal news for the week of October 6, 2014

October 6, 2014 By MassDevice Leave a Comment

Appeals court vacates FDA's rescission of ReGen's MenaFlex implant

September 29, 2014 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), Legal News, News Well Tagged With: American Medical Systems Holdings Inc., Boston Scientific, Endo Health, Legal Roundup, Masimo, Philips, ReGen Biologics Inc., U.S. Congress

Appeals court vacates FDA’s rescission of ReGen’s MenaFlex implant

September 29, 2014 By Brad Perriello Leave a Comment

Appeals court vacates FDA's rescission of ReGen's MenaFlex implant

Filed Under: Food & Drug Administration (FDA), Legal News, News Well Tagged With: Orthobiologics, ReGen Biologics Inc., U.S. Congress

Inside stock traders gain jail time for Stryker case | Medtech legal news for the week of Apr. 14, 2014

April 14, 2014 By MassDevice Leave a Comment

Inside traders draw jail time in Stryker case

April 10, 2014 by Brad Perriello

Inside traders draw jail time in Stryker case

Filed Under: Food & Drug Administration (FDA), Legal News Tagged With: ArthroCare Corp., I-Flow Corp., Legal Roundup, Progressive Medical, ReGen Biologics Inc., Smith & Nephew, St. Joseph Medical Center, Stryker, Wake Forest University

ReGen Biologics appeals loss to FDA

April 9, 2014 By Brad Perriello Leave a Comment

ReGen Biologics appeals loss to FDA

ReGen Biologics’ long battle against the FDA entered a new phase this year, with the medical device company’s appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA’s decision to rescind the clearance granted to ReGen’s Menaflex knee implant.

Filed Under: Food & Drug Administration (FDA), Legal News, News Well, Regenerative Medicine, Regulatory/Compliance Tagged With: Knees, ReGen Biologics Inc.

Bankrupt ReGen terminates its stock

June 16, 2011 By MassDevice staff

FDA, ReGen Biologics

ReGen Biologics Inc. (OTC:RGBO) terminated its common stock registration in connection with its bankruptcy proceedings connected to the FDA’s rescission of 510(k) clearance for the company’s Menaflex knee implant.

Earlier this month ReGen sued the FDA, it’s top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding the clearance.

Filed Under: Business/Financial News, Legal News, News Well Tagged With: ReGen Biologics Inc.

ReGen Biologics sues FDA over 510(k) rescission

June 1, 2011 By MassDevice staff Leave a Comment

ReGen Biologics, FDA

ReGen Biologics Inc. sued the FDA, its top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding a clearance for ReGen’s Menaflex knee implant earlier this year.

Filed Under: 510(k), Food & Drug Administration (FDA), Legal News, News Well Tagged With: ReGen Biologics Inc.

Judge rules no infringement in Medtronic patent spat with Boston Scientific | Legal Roundup

May 2, 2011 By MassDevice staff Leave a Comment

gavel

A federal judge handed a win to Medtronic Inc. (NYSE:MDT) in its patent spat over implantable cardiac defibrillators with Boston Scientific (NYSE:BSX), ruling that Medtronic didn’t violate a pair of valid BSX patents.

Filed Under: Legal News, News Well, Patent Infringement Tagged With: Alere, Boston Scientific, Candela Corp., Chinmax Medical Products Inc., Off Madison Ave. Inc., Palomar Medical Technologies Inc., ReGen Biologics Inc., Syneron Medical Ltd.

Bankrupt ReGen gets another cash infusion through investor | Funding roundup

April 28, 2011 By MassDevice staff Leave a Comment

Funding

Bankrupt ReGen Biologics Inc. (OTC:RGBO) took out a loan from a company affiliated with one of its investors. The new debt represents Regen’s second financing deal with the company since filing for Chapter 11 bankruptcy two weeks ago.

Filed Under: News Well Tagged With: Bankruptcy, Bill & Melinda Gates Foundation, CareView Communications Inc., Cianna Medical, Gene Security Network, Hospira Inc., Illumina Inc., Interrad Medical Inc., Meritech Capital Partners, ReGen Biologics Inc., Solta Medical Inc., Venture Capital/Private Equity

Regen Biologics files for bankruptcy

April 11, 2011 By MassDevice staff Leave a Comment

FDA, ReGen Biologics

ReGen Biologics Inc. (PINK:RGBO) filed for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware.

Filed Under: News Well, Orthopedics Tagged With: Bankruptcy, Debt Financing, ReGen Biologics Inc.

FDA makes ReGen 510(k) rescission final

April 6, 2011 By MassDevice Leave a Comment

FDA, ReGen Biologics

ReGen Biologics Inc. (OTC:RGBO) is weighing options for the Menaflex knee implant the FDA forced off the market last week.

The agency rescinded its 2008 510(k) clearance for the Hackensack, N.J.-based company’s embattled bio-absorbable knee implant last October. Last month ReGen rebuffed an offer from the FDA for a final hearing on the decision.

Filed Under: Food & Drug Administration (FDA), Implants, News Well Tagged With: Knees, ReGen Biologics Inc.

ReGen Biologics: We’re too broke to file our annual report

March 31, 2011 By MassDevice staff Leave a Comment

FDA, ReGen Biologics

ReGen Biologics Inc. (PINK:RGBO) doesn’t have enough money to pay for its annual earnings filing with the Securities & Exchange Commission.

Filed Under: Food & Drug Administration (FDA), MassDevice Earnings Roundup, News Well, Wall Street Beat Tagged With: Q4, ReGen Biologics Inc.

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