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Orthopedic and Dental Industry News Complete Archive »

Investigations

Hospitals to Settle with Federal Government over Fraudulent Billing Scheme BY ANDREW VAHRADIAN, JULY 9, 2013

Fifty-five hospitals in 21 states will be paying a total of $34 million to the federal government in order to settle allegations that they overcharged Medicare and other government healthcare programs for kyphoplasty back procedures. The settlements were the result... more

Musculoskeletal News Roundup 29-Mar-12 BY LAUREN UZDIENSKI, MARCH 29, 2012

Mazor reports earnings .... Omni Surgical raises $27M ... Relievant Medsystems raises $30M ... FDA warning letters for Lucero Medical, Orthopedic Alliance and Spinal Solutions ... Benvenue Medical launches Blazer Vertebral Augmentation System ... Aperion Biologics completes enrollment in Z-Lig ACL study ... Benvenue Medical announces enrollment of 250th patient in KAST (Kiva System) study ... Ascendx Spine inks distribution deal in Austria, Germany and Switzerland more

Biomet Settles FCPA Allegations BY LAUREN UZDIENSKI, MARCH 27, 2012

Biomet settled a federal investigation into alleged violations of the Foreign Corrupt Practices Act (FCPA) for around $23 million. The investigation concerned $1.5 million in payments to healthcare providers in Argentina, Brazil and China that spanned the years between 2000 and 2008. more

Musculoskeletal News Roundup 9-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 9, 2012

Product launches from AAOS ... Nobel Biocare announces 4Q ... Hospitals settle Medicare fraud claims over kyphoplasty billing ... Updates on the American Joint Replacement Registry ... Stryker announces inventory management system rollout more

Orthofix, Smith & Nephew Reach Agreements with U.S. Government BY LAUREN UZDIENSKI, FEBRUARY 7, 2012

In separate announcements yesterday, both Orthofix and Smith & Nephew reported that respective investigations by the U.S. government into certain business practices are being resolved. Orthofix's stock reacted positively to the news, with shares up 4% in morning trading. Smith & Nephew's stock is down 1% this morning. more

Musculoskeletal News Roundup 20-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 20, 2011

KNSY, JNJ, Medicrea, SYK, SYST announce 3Q . . . BMTI receives Australian approval for Augment . . . FDA clears Medtronic's Aquamantys3 System . . . K2M launches RAVINE Lateral Access System . . . Medicrea highlights six products at Eurospine . . . Globus to fund MIS spine outcomes registry . . . Zimmer to distribute Benvenue's Kiva . . . Lanx creates Surgeon Advisory Board more

Musculoskeletal News Roundup 9-Jun-11 BY LAUREN UZDIENSKI, JUNE 9, 2011

Brainlab to acquire Voyant Health . . . FDA clears ARTC's Spartan 6.5 Needled Anchor . . . Mazor Robotics launches next-gen Renaissance system . . . DFINE comments on VCF study results . . . Senators request investigation of PODs . . . Arteriocyte announces army stem-cell research project more

Musculoskeletal News Roundup 9-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 9, 2010

SBi sells shoulder assets . . . Ortho Kinematics raises $2M . . . FDA clears VITA's Vitoss Bioactive Foam-2X . . . Life Spine announces first cases with the OCTAVE Posterior Fusion System . . . WMGI initiates limited rollout of the PRO-TOE VO Hammertoe Fixation System . . . BMTI begins enrollment on Augment Rotator Cuff pilot study . . . Audax Medical licenses biomaterial from Brown University . . . NeoStem entity to bring orthopedic stem cell treatments to Shijiazhuang, China . . . EXAC resolves DOJ investigation more

Musculoskeletal News Roundup 5-Aug-10 BY LAUREN UZDIENSKI, AUGUST 5, 2010

ATEC, ARTC, BMTI, DJO, EXAC, MAKO, VITA, RTIX, SNN, SMA, TSON, WMGI report 2Q:10 . . . Bacterin closes private placement . . . Wright Medical launches the EVOLUTION Medial-Pivot Knee . . . VertiFlex enrolls 150th patient in their IDE study more

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI, MARCH 11, 2010

OR_small.jpg The latest news from AAOS! VITA and MAKO report 4Q09 . . . ETEX receives 510(k) . . . DePuy, Integra, Medtronic, Smith & Nephew and more announce product launches . . . SEC Drops Wright Medical Investigation . . . BioMimetic Therapeutics shares study results . . . Long-term use of bisphosphonates may increase fracture risk . . . NeoStem wins research grant more

Stryker Biotech Indicted Over OP-1 Marketing BY LAUREN UZDIENSKI, OCTOBER 28, 2009

Stryker Biotech is facing a federal indictment after a long investigation into its sales of OP-1 (BMP-7), which was approved by the FDA under an HDE. An HDE stipulates that a device will be used in less than 4,000 patients... more

Musculoskeletal News Roundup 1-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 1, 2009

Earnings MEDICREA reported revenues of EUR 6.1 million ($8.6 million) in 1H:09, representing a 32% increase over 1H:08, which the company attributed to growth in sales from direct subsidiaries, primarily in the United States. Net loss was EUR 1.5 million... more

Musculoskeletal News Roundup 24-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 24, 2009

Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more

Musculoskeletal News Roundup 6-Aug-09 BY LAUREN UZDIENSKI, AUGUST 6, 2009

Earnings Alphatec Spine, Inc. announced financial results for FQ2:09. Consolidated revenues for the second quarter 2009 were $32.3 million, an increase of 35% from 2Q:08 and an increase of 5% over first quarter 2009. Adjusted EBITDA reached $2.8 million in... more

Muscloskeletal News Roundup 16-Jul-09 BY LAUREN UZDIENSKI, JULY 16, 2009

Earnings Biomet reported FQ4:09 sales of $639.3 million, representing a 7% increase over the year-ago period. Among segments, hip increased 9%; knee increased 11%; extremity increased 18%; dental decreased 13%; fixation increased 5%; and spine increase 18%. All growth rates... more

DOJ Investigates Kyphoplasty Claims Over Alleged Medicare Violations BY LAUREN UZDIENSKI, JULY 16, 2009

According to the Report on Medicare Compliance, the DOJ is conducting an investigation into Medicare inpatient claims for kyphoplasty at hospitals nationwide. The probe stems from a whistleblower lawsuit from two former Kyphon sales and reimbursement managers who claimed that... more

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI, JUNE 25, 2009

Funding BioMimetic Therapeutics raised approximately $17.0 million in a rights offering that closed on Wednesday. The company offered 2,000,000 shares at $8.50 per share in May. The company plans to use the funds for general corporate purposes, including to product... more

Musculoskeletal News Roundup 18-Jun-09 BY LAUREN UZDIENSKI, JUNE 19, 2009

M&A The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT... more

Musculoskeletal News Roundup 21-May-09 BY LAUREN UZDIENSKI, MAY 21, 2009

Earnings Medtronic reported FQ4:09 revenue of $3.8 billion, representing a 5% increase (constant currency) over FQ4:08 and in line with estimates. Adjusted EPS for the quarter was $0.82, also in line with estimates. Spine and biologics revenue was $881.0 million,... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more

Musculoskeletal News Roundup 7-May-09 BY LAUREN UZDIENSKI, MAY 7, 2009

Earnings Alphatec Spine reported record consolidated revenue of $30.6 million reported in 1Q:09, which represents 32% growth over 1Q:08 and 8% sequential growth over revenues reported in 4Q:08. U.S. revenue growth of 28% over prior year was approximately three times... more

Musculoskeletal News Roundup 16-Apr-09 BY LAUREN UZDIENSKI, APRIL 16, 2009

Earnings JNJ reported 1Q:09 sales of $15.0 billion, missing estimates by $0.4 billion and representing a 7% decline over 1Q:08, which the company attributed mostly to unfavorable exchange rates. Net income was $3.5 billion, or $1.26 per diluted share, beating... more

WSJ Reports on ReGen's Campaign Donations BY LAUREN UZDIENSKI, APRIL 7, 2009

The WSJ published additional details of its investigation into ReGen Biologics' FDA clearance for its Menaflex meniscal implant. New information out this morning includes details of campaign donations from ReGen executives to the New Jersey politicians who stood behind ReGen... more

Musculoskeletal News Roundup 2-Apr-09 BY LAUREN UZDIENSKI, APRIL 2, 2009

Earnings Corin reported 2008 revenues of GBP 39.8 million ($57.6 million), an 8% increase over 2007 sales. The company also reported a pretax loss of GBP 3.9 million ($5.6 million), which reflected a GBP 5.2 million ($7.2 million) inventory write-down... more

Four of Big Five Settle with DOJ; Compliance Monitors Leave BY DAVID KRESSEL, MARCH 31, 2009

Eighteen months after the Department of Justice entered into Deferred Prosecution Agreements (DPA) with Smith & Nephew, Johnson & Johnson (Depuy), Zimmer and Biomet, and a Non-Prosecution Agreement with Stryker, the DOJ has announced it has dismissed the criminal charges... more

Musculoskeletal News Roundup 12-Mar-09 BY LAUREN UZDIENSKI, MARCH 12, 2009

Earnings BioMimetic Therapeutics reported a net loss in 4Q:08 of $12.2 million, or $0.65 per share, widening from a net loss of $6.9 million, or $0.37 per share, in 4Q:07. Analysts had forecast a net loss of $0.53 per share.... more

Musculoskeletal News Roundup 19-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 20, 2009

Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more

Musculoskeletal News Roundup 20-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 20, 2008

Earnings Medtronic reported FQ2:09 revenues of $3.57 billion, up 14% (8% constant currency) over the year-ago period and missing estimates by $0.12 billion. Non-GAAP net earnings and diluted earnings per share were $758.0 million, or $0.67 per diluted share, missing... more

SEC's Foreign Sales Probe Widens to Include Wright Medical BY LAUREN UZDIENSKI, JUNE 18, 2008

Last fall, Biomet, Medtronic, Smith & Nephew, Stryker and Zimmer announced they were under investigation by the SEC for possible violations of the Foreign Corrupt Practices Act (FCPA), which is designed to prevent U.S. companies from making payments to foreign... more

Musculoskeletal News Roundup 12-June-08 BY ARMELLE WIART, JUNE 12, 2008

M&A Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The... more

Musculoskeletal News Roundup 27-Mar-08 BY LAUREN UZDIENSKI, MARCH 27, 2008

Earnings DJO Inc., formerly ReAble Therapeutics, reported 4Q:07 net sales of $170.7 million, a 97% increase over 4Q:06; the growth rate was due primarily to acquisitions, including ReAble's merger with DJO. The company reported an actual net loss of $57.3... more

Musculoskeletal News Roundup 20-Mar-08 BY LAUREN UZDIENSKI, MARCH 20, 2008

Earnings Biomet announced preliminary FQ3:08 revenues of $603.1 million, an increase of 14% over the year-ago period. By segment, reconstructive device sales increased 19% worldwide and 13% in the U.S.; knee sales increased 24% worldwide and 21% in the U.S.,... more

Musculoskeletal News Roundup 6-Mar-08 BY LAUREN UZDIENSKI, MARCH 6, 2008

Earnings Anika Therapeutics reported 4Q:07 product revenue of $7.9 million, in line with estimates and up from $5.08 million for the same period last year. The revenue growth was attributed to domestic and international sales of the ORTHOVISC product line,... more

Musculoskeletal News Roundup 28-Feb-2008 BY LAUREN UZDIENSKI, FEBRUARY 28, 2008

Earnings Artimplant reported 4Q:07 revenues of SEK 5.0 million ($0.8 million), up from SEK 1.6 million ($0.25 million) in the year-ago period. The net loss for 4Q:07 was SEK 2.1 million ($0.34 million), improved from a loss of SEK 9.5... more

Musculoskeletal News Roundup 7-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 7, 2008

Earnings Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... more

Musculoskeletal News Roundup 17-Jan-07 BY LAUREN UZDIENSKI, JANUARY 17, 2008

Earnings Biomet reported earnings for 2FQ:08 last week, with net sales up 11% to $578.1 million over the comparable quarter. Worldwide, knee sales were up 17%, and hip was up 12%. Extremity sales increased 11% and bone cements and accessories... more

Musculoskeletal News Roundup 10-Jan-08 BY LAUREN UZDIENSKI, JANUARY 10, 2008

M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more

Musculoskeletal News Roundup 13-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 13, 2007

Earnings Tutogen reported FY07 revenues of $53.8 million, an increase of 42% over FY06. The Company reported net income of $6.8 million, or $0.36 per fully diluted share in fiscal year 2007 compared to a net loss of $0.6 million,... more

Wright Medical, Exactech Subpoenaed Over Surgeon Payments BY LAUREN UZDIENSKI, DECEMBER 12, 2007

Wright Medical announced late yesterday that the company received a DOJ subpoena requesting documents on any surgeon consulting and professional service agreements dating from 1998 to the present. The company said the subpoena pertained specifically to agreements relating to hip... more

Musculoskeletal News Roundup 1-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 1, 2007

Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more

Biomet, DePuy, Smith & Nephew, Stryker and Zimmer Disclose Payments Made to Consultants BY LAUREN UZDIENSKI, OCTOBER 31, 2007

Available on Biomet, DePuy, Smith & Nephew, Stryker and Zimmer's websites today are disclosures of the companies' payments to consultants. The public disclosure of consultant payments was among the terms in the deferred prosecution agreements (in Stryker's case, a non-prosecution... more

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more

SEC Investigates Biomet for Possible Violations of the Foreign Corrupt Practices Act BY LAUREN UZDIENSKI, OCTOBER 12, 2007

Biomet announced yesterday in a preliminary earnings release for FQ1:08 that the company was under investigation for possible violations of the Foreign Corrupt Practices Act (FCPA). The investigation was said to be informal and involve other companies in addition to... more

Musculoskeletal News Roundup 28-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 28, 2007

Legal Federal prosecutors announced on Thursday the terms of a settlement with Zimmer, Depuy, Biomet, Smith & Nephew and Stryker following an investigation into physician compensation practices. Zimmer, Depuy, Biomet and Smith & Nephew entered into deferred prosecution agreements and... more

Zimmer, Depuy, Biomet, Smith & Nephew and Stryker Settle DOJ Investigation for $311 million BY LAUREN UZDIENSKI, SEPTEMBER 27, 2007

Federal prosecutors announced today the terms of a settlement with Zimmer, Depuy, Biomet, Smith & Nephew and Stryker following an investigation into physician kickbacks. Zimmer, Depuy, Biomet and Smith & Nephew entered into deferred prosecution agreements (where a company can... more

Musculoskeletal News Roundup 2-August-07 BY LAUREN UZDIENSKI, AUGUST 2, 2007

Earnings Large Joint: Exactech announced 2Q:07 revenue of $31.6 million, beating estimates of $29.9 million and up 19% from the comparable quarter. CEO Bill Petty attributed the growth to "acceptance of our new products and continuing success of our products... more

Orthofix Receives Subpoena from OIG BY DAVID KRESSEL, JULY 30, 2007

Orthofix announced via an 8-K filing that its Blackstone Medical subsidiary received a subpoena from the Department of Health and Human Service's Office of the Inspector General (OIG). The 8-K stated the investigation concerns physician consultant compensation as it relates... more

Orthopedic News Roundup 31-May-07 BY LAUREN UZDIENSKI, MAY 31, 2007

Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more

Biomet Receives New Round of Federal Subpoenas BY ARIELLA P. GOLOMB, MD, MAY 29, 2007

Just as one DOJ investigation seemed to be coming to a close, Biomet reported late last week that the company is facing new subpoenas from federal prosecutors. The government is requesting documents from as far back as 1999 relating to... more

Star-Ledger: DOJ Settlement Could Come this Summer BY LAUREN UZDIENSKI, MAY 24, 2007

A DOJ investigation into surgeon compensation practices by Biomet, Depuy, Smith & Nephew, Stryker and Zimmer in 2005 could reach a settlement "as soon as this summer," according to the Star-Ledger's John P. Martin. Current terms of the settlement are... more

Orthopedic News Roundup 5-Apr-07 BY LAUREN UZDIENSKI, APRIL 4, 2007

Earnings aap Implantate AG announced 2006 revenues of EUR 18.5 million, up 38% from the previous year. The aap Group attributed the growth to the Biomaterials segment, where sales increased by 64% to EUR 12.2 million. Biomaterials now generates two... more

What Does Backdating Options Really Mean for Biomet? BY LAUREN UZDIENSKI, APRIL 3, 2007

Preliminary findings from an investigation into Biomet's options backdating announced last week showed a $50 million discrepancy between 1996 and 2006, and CFO Gregory D. Hartman and Exective Vice President of Administration Daniel P. Hann have both resigned. What does... more

H.R.D.I. Settles Conflict Case BY LAUREN UZDIENSKI, JANUARY 25, 2007

Last July, we reported on a Connecticut lawsuit against the Healthcare Research and Development Institute (H.R.D.I), a for-profit consulting firm that advised pharmaceutical, medical device and financial services companies on selling their products to hospitals. Yesterday, following an investigation by... more

Physician Income Cut BY LAING RIKKERS, AUGUST 11, 2006

This week CMS proposed a 5.1% reduction in payments to physicians for 2007. The proposal will impact the 875,000 doctors who care for the elderly and disabled in the US. The explanation for the cut is that spending on physician... more

Zimmer Provides More Info: DOJ Investigating Price-Fixing BY ARIELLA P. GOLOMB, MD, JULY 27, 2006

In yesterday's quarterly report press release Zimmer shared more information on the nature of the recent DOJ investigations into the Orthopedics Industry. The ongoing investigation is related to a price-fixing scheme, initiated by one of Zimmer's competitors at a specific... more

Stryker Reports 2Q:06 Earnings, States DOJ Probe Narrowed BY ARIELLA P. GOLOMB, MD, JULY 24, 2006

Thursday, Stryker Corporation reported its 2Q:06 operating results. Net sales increased 9.0% to $1.33 billion, slightly below analysts' expectations of $1.34 billion. Operating income rose 16% and net income more than 20%. Diluted EPS for 2Q:06 increased 20.9% to $0.52,... more

Medtronic Settles with DOJ on Kickbacks for $40 Million BY DAVID KRESSEL, JULY 18, 2006

Medtronic announced yesterday that it has settled with the Department of Justice regarding a qui tam lawsuit related to sales and marketing practices in its Spine group, particularly kickbacks to surgeons. Qui tam lawsuits are better known as whistleblower suits.... more

FDA Grants IDE For Medtronic's DIAM(TM) Spinal Stabilization System BY ARIELLA P. GOLOMB, MD, JULY 10, 2006

Medtronic, Inc. announced today that the FDA granted an investigational device exemption (IDE) to the DIAM(TM) Spinal Stabilization System for use in a clinical safety and effectiveness study. The DIAM System will be measured against posterior lumbar interbody fusion, the... more

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN, JUNE 29, 2006

Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's... more

Biomet Also Receives Subpoena BY JOHN MCCORMICK, JUNE 26, 2006

This morning, Biomet announced that it has a subpoena from the Department of Justice, Antitrust Division, requesting documents regarding possible violations of federal criminal law, including possible violations of the antitrust laws, relating to the manufacture and sale of orthopedic... more

Zimmer Gets Dept. of Justice Subpoena BY JOHN MCCORMICK, JUNE 26, 2006

Zimmer Holdings Inc. said Friday the Justice Department's antitrust division subpoenaed company documents pertaining to an investigation of possible violations of federal criminal law, including possible violations of antitrust laws, involving the manufacture and sale the Company's standad lines of... more

IND Approval Granted For Zimmer/ISTO Technologies' Neocartilage Graft BY ARIELLA P. GOLOMB, MD, JUNE 21, 2006

Each year, hundreds of millions of people injure the cartilage in their knees, shoulders and other joints. Today Zimmer Holdings and ISTO Technologies announced that the U.S. Food and Drug Administration (FDA) has approved ISTO's Investigational New Drug (IND) application... more

Breakthrough For Rare Orthopedic Genetic Disorder; Broad Implications For Orthopedics BY ARIELLA P. GOLOMB, MD, JUNE 9, 2006

A Single Codon Mutation Causes A Debilitating Disease Fibrodysplasia Ossificans Progressiva (FOP) is a rare autosomal dominant genetic disorder that causes muscles and other connective tissue to turn into bone and is estimated to affect one in two million patients... more

Medical Device Trade in Foreign Markets -- Investigation BY HUYEN NGUYEN, APRIL 5, 2006

The U.S. International Trade Commission (ITC) issued a press release yesterday announcing the launch of a fact-finding investigation into conditions affecting U.S. trade of medical devices and equipment in principal foreign markets, particularly the Japanese market. The House Ways and... more

Orthopedic News Roundup 23-Mar-06 BY HUYEN NGUYEN, MARCH 23, 2006

This week at HealthpointCapital, we compiled a brief synopsis of the 2006 Orthopedic Industry, projecting that total revenue in 2006 will grow by 12% for the year. Appointment: Two notable extremities companies named their new CEOs this week: Wright Medical... more

Orthopedic News Roundup 23-Feb-06 BY LAING RIKKERS, FEBRUARY 23, 2006

Financing: BioMimetic Therapeutics, Inc. filed a registration statement for an Initial Public Offering. Earnings: Medtronic 3Q Earnings climb 23 percent. CryoLife fourth quarter 2005 revenues increased 13% over fourth quarter 2004 Gross margins for full year 2005 increased to 53%... more

Marketing at Academic Medical Centers under Attack BY LAING RIKKERS, FEBRUARY 2, 2006

Doctors pushed back against marketing and commercial pressures from the pharmaceutical and medical device industries last week. On January 25, the American Medical Association (JAMA) published "Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical... more

Update on Surgeons' Subpoenas (DOJ Investigations) BY SUSAN BERSON, NOVEMBER 9, 2005

[Editor's note: We welcome attorney Susan Berson of Mintz, Levin as a guest blogger. See her profile here.] Earlier this year, the government announced investigations of several device manufacturers charging that the manufacturers were offering inappropriate incentives to referring physicians... more

Department of Justice Questioning the Selling Practices of Medtronic, Guidant and St. Jude BY JOHN CHOPACK, OCTOBER 26, 2005

Medtronic, Guidant and St. Jude Medical said they each received subpoenas from the U.S. Attorney in Massachusetts related to their heart devices. Medtronic also stated that the subpoenas sought documents related to people in a position to recommend purchase of... more

Lifecell Recalls BTS Products After Criminal Probe BY DAVID KRESSEL, OCTOBER 10, 2005

In the wake of an FDA, NYPD and Brooklyn district attorney's investigation into Biomedical Tissue Services, Lifecell has recalled and halted sales of all tissue from BTS. BTS's CEO is under investigation for illegally harvesting tissue from cadavers at a... more

DOJ Attorney Speaks on Subpoenas BY SUSAN BERSON, JUNE 23, 2005

Last week I listened in on an audio conference regarding the DOJ investigations. Certain comments by Jim Sheehan, AUSA for the Eastern District of Pennsylvania were quite interesting and provide some guidance... more

No Hanky Panky at FDA: Crawford Confirmation Moves Forward BY JOHN MCCORMICK, JUNE 9, 2005

An inquiry requested by Wyoming Senator Mike Enzi, concluded yesterday clearing acting Food and Drug Administration Commissioner Lester Crawford of having an extramarital affair with an agency employee. The inquiry was conducted by the inspector general of the Department of... more

The Industry Subpoenaed: Our Perspective BY JOHN MCCORMICK, APRIL 4, 2005

The healthcare industry has long been the subject of regulation by complex laws that do not exist in other industries and which, under certain circumstances, may seem almost excessive and counter-intuitive. The enforcement of these laws has been significant and... more

More problems at CryoLife - and it goes well beyond sales or earnings. BY EDITOR, AUGUST 11, 2003

CryoLife reported a loss of $22.3 million on sales of $15.7 million for the quarter ended June 30. Orthopedic sales, which amounted to $280,000, were less than we'd expected and appear to have been delayed from management's earlier forecasts. But... more


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