Legal: Page 2
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Boston Scientific says Biocardia doesn't own women's health patents, denies stealing trade secrets
Boston Scientific is asking a court to determine it didn't steal BioCardia's trade secrets and to clear up patent ownership of an early-detection diagnostic tool for ovarian cancer it acquired when it purchased nVision.
By Dana Elfin • Sept. 09, 2019 -
Telemedicine CEO pleads guilty in $424M Medicare kickback scheme
The executive admitted to seeking and getting bribes from patient recruiters, pharmacies and brace suppliers in return for arranging for doctors to order medically unnecessary orthotic braces.
By Dana Elfin • Sept. 09, 2019 -
Dexcom beats WaveForm's patent suit over CGM sensors
A U.S. District Court judge's decision ends the ongoing dispute between San Diego-based continuous glucose monitor maker Dexcom and WaveForm Technologies, a subsidiary of blood glucose meter manufacturer AgaMatrix.
By Dana Elfin • Aug. 26, 2019 -
Conformis sues Zimmer Biomet over patent infringement
Knee implant maker Conformis is seeking triple damages amid its claim that Zimmer Biomet infringed multiple of its patents for patient-specific instrument systems and techniques for joint replacement surgery.
By Susan Kelly • Aug. 20, 2019 -
Senators push HHS for details of response to DNA test scam
Lawmakers propose pre-claim review of genetic test orders to root out fraud.
By Nick Paul Taylor • Aug. 15, 2019 -
Ambu to pay $3.3M to settle False Claims Act allegations
The Danish medical device maker is accused of manufacturing products in China and Malaysia and knowingly selling them to U.S. government agencies in violation of the 1979 Trade Agreements Act.
By Susan Kelly • Aug. 12, 2019 -
Q&ACalifornia's AG on suing J&J for deceptive mesh marketing, defending ACA
Xavier Becerra also spoke to MedTech Dive about medical product safety.
By Dana Elfin • Aug. 08, 2019 -
Zimmer hit with $7.7M in damages in hip implant case
The company has now paid more than $400 million in metal-on-metal hip implant cases but still expects to pay out around $130 million more in relation to lawsuits involving Durom Cup and similar devices sold by its Biomet unit.
By Nick Paul Taylor • Aug. 06, 2019 -
Appeals court kicks ACLA lawsuit back to lower court
The ruling is a blow to the government, which argued collection of market data was inextricably intertwined with the establishment of payment rates and therefore wasn't reviewable by the courts.
By David Lim • July 31, 2019 -
Humana accuses Abbott of duping it to pay to remove dodgy heart devices
The suit alleges St. Jude, now a part of Abbott, knew about a battery depletion defect in its heart rhythm devices for four years before notifying FDA, and then schemed to have the insurer pay for surgeries to remove patients' implants.
By Susan Kelly • July 30, 2019 -
DOJ alleges spine maker paid $7M to surgeons in kickbacks
According to the lawsuit, privately held Life Spine failed to report some of the $7 million it paid to surgeons from 2012 to 2018.
By Nick Paul Taylor • July 25, 2019 -
OpinionMedical device corrections, removals and recalls: Where are we now?
Companies must balance maintaining a credible relationship with FDA while resisting actions that may not ultimately be in the best interests of patient safety, write Hogan Lovells' Jodi Scott and Wil Henderson.
By Jodi Scott and Wil Henderson • July 19, 2019 -
Sterigenics strikes deal to reopen Willowbrook sterilization plant
The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • UPDATED: Sept. 9, 2019 at 10:41 a.m. -
CMS outlines home infusion therapy benefit in proposed rule
Home infusion therapy allows for the delivery of certain drugs, such as anti-infectives, chemotherapy or treatment for immune deficiencies, with the use of a durable medical equipment pump at a patient's home.
By David Lim • July 12, 2019 -
International Trade Commission probes Intuitive imports following J&J complaint
The ITC began the investigation after J&J's Ethicon argued certain Intuitive stapler cartridges infringe its patents.
By Nick Paul Taylor • July 03, 2019 -
FDA ends alternative reporting program, pledges to make MAUDE user friendly
The agency disclosed more than 6 million medical device adverse event reports were filed under the controversial system since 1997.
By David Lim • June 24, 2019 -
SEC ends Misonix foreign corruption probe without action
The maker of ultrasonic devices triggered the investigation in 2016 when it contacted the SEC with information about the business practices of its Chinese distributor.
By Nick Paul Taylor • June 21, 2019 -
Cardiology practice pays $2.5M to settle case involving genetic testing kickback allegations
In the latest case involving improper billing of Medicare for genetic tests, Nevada Heart & Vascular Center allegedly referred patients to Natural Molecular Testing and Iverson Genetic Diagnostics for payments.
By Nick Paul Taylor • June 20, 2019 -
SponsoredDear medtech: I'm not sick, so why do you keep calling me a 'patient'?
With the entrance of consumer tech into the medtech industry, it's more important than ever to examine and evaluate clinical terms.
By Brian Chapman • June 18, 2019 -
OIG estimates Medicare overpaid $269M for sleep studies
OIG thinks the problems occurred because CMS failed to provide the oversight needed to stop payments for noncompliant claims.
By Nick Paul Taylor • June 13, 2019 -
Device maker to pay $15M to resolve false claims allegations, 'silent recall'
ACell failed to report a product recall to FDA and billed Medicare for indications sales reps knew were not backed by clinical data to receive inflated reimbursement, the Department of Justice said.
By David Lim • June 12, 2019 -
11.9M Quest Diagnostics patients potentially exposed to data breach
Financial, medical and other personal information, such as Social Security numbers, may have been exposed, the company reported Monday morning.
By David Lim • June 03, 2019 -
Philadelphia jury awards $80M in J&J pelvic mesh suit
Awards in mesh cases against Ethicon in the Pennsylvania court now total $346 million.
By Susan Kelly • May 20, 2019 -
Ra Medical files suit alleging rival interfered with IPO
Separately, Nasdaq notified Strata Skin Sciences on Friday it is out of compliance with the market's continued listing requirements due to delays in filing quarterly and annual reports.
By Susan Kelly • May 20, 2019 -
FTC judge upholds unraveling of microprocessor prosthetic knee firms deal
Ottobock must sell off its recent acquisition of microprocessor prosthetic knee maker Freedom Innovations over FTC's market concentration concerns.
By Dana Elfin • UPDATED: May 8, 2019 at 2 p.m.
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