Legal: Page 2
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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. -
Touchstone Medical Imaging pays $3M to settle HIPAA breach case
HHS found Touchstone failed to properly investigate the security incident until months after it learned of the breach.
By Nick Paul Taylor • May 07, 2019 -
Labs make their case against PAMA cuts to 3-judge panel
If the U.S. Court of Appeals for the District of Columbia rules in favor of the American Clinical Laboratory Association, Quest Diagnostics and LabCorp stand to gain on Wall Street.
By David Lim • April 25, 2019 -
DOJ indicts 24 people in $1.2B DME, telehealth fraud scheme
The defendants include CEOs and COOs of five telemedicine companies, the owners of dozens of durable medical equipment companies and three licensed medical professionals.
By Les Masterson • April 10, 2019 -
Stryker names J&J lawyer as chief legal officer
Rob Fletcher spent 15 years at Johnson & Johnson, taking on jobs including general counsel for medical devices.
By Nick Paul Taylor • March 28, 2019 -
Key senators demand answers about 'suspect' doctor-device maker ties
Bipartisan leaders of the Senate Finance Committee want CMS to probe whether physician-owned distributorships of medical implants are failing to meet Sunshine Act requirements.
By Nick Paul Taylor • March 22, 2019 -
Durable medical equipment business owner gets prison time for Medicaid fraud
The case involved the submission of $9.8 million in false and fraudulent durable medical equipment claims.
By Nick Paul Taylor • March 14, 2019 -
Oral arguments in ACLA v. Azar appeal set for April 23
In a brief, HHS argued the American Clinical Laboratory Association does not have standing to bring a lawsuit over implementation of the Protecting Access to Medicare Act.
By David Lim • March 07, 2019 -
Gottlieb pledges device, drug reviews will be on time post shutdown
The FDA chief's appearance before Congress comes a day after a bill was introduced to allow the agency to accept new medical device applications and user fees during a government shutdown.
By David Lim • Feb. 28, 2019 -
Feds team up to speed diagnostic testing access in emergencies
Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.
By David Lim • Feb. 27, 2019 -
GenomeDx pays $2M to settle genetic test false claims allegations
The U.S. government accused the company of billing Medicare for unnecessary prostate cancer tests.
By Nick Paul Taylor • Feb. 13, 2019 -
EHR vendor Greenway Health hit with $57.25M False Claims fine
In addition to misrepresenting the capabilities of its software, the company is accused of falsely obtaining 2014 Edition certification status for its Prime Suite EHR.
By Meg Bryant • Feb. 07, 2019 -
Deep DiveClinical lab lobbying spikes as PAMA cuts kick into effect
Paralleling CMS payment cuts that took effect at the start of last year, lobbying by Quest Diagnostics, LabCorp and the American Clinical Laboratory Association jumped to $4.4 million, up from $2.5 million in 2017.
By David Lim • Feb. 01, 2019 -
HHS to seek changes to anti-kickback laws by year end
The bid to overhaul the Stark Law and Anti-Kickback Statute comes as lawmakers propose legislation to facilitate value-based arrangements connecting the price of a medical device or drug to clinical effectiveness.
By David Lim • Jan. 31, 2019 -
Device lobby pushes bill to let FDA take user fees amid shutdown
But the proposal does not appear to be poised for movement. Democrats on the House Energy & Commerce Committee oppose the legislation, a Democratic committee staffer told MedTech Dive.
By David Lim • Jan. 24, 2019 -
J&J hit with $120M bill in 46-state hip implant marketing settlement
South Carolina and Texas led the effort alleging Johnson & Johnson mischaracterized the longevity and safety of two DePuy Orthopaedics hip replacement products no longer on the market.
By Maria Rachal • Jan. 23, 2019 -
Edwards Lifesciences pays Boston Scientific $180M to settle multiple patent disputes
Edwards will make a one-time payment to Boston and the companies will drop all other patent suits and appeals related to their current portfolios of heart technologies.
By Maria Rachal • UPDATED: Jan. 15, 2019 at 11:04 a.m. -
Senate Democrats question Gottlieb on FDA shutdown impact
FDA Commissioner Scott Gottlieb wrote Tuesday on Twitter the agency has returned 100 inspection staff to work to oversee high-risk medical device facilities.
By David Lim • UPDATED: Jan. 16, 2019 at 8:48 a.m. -
OIG finds Pacific Medical received unallowable Medicare payments
The oversight body wants the provider of orthotic braces to refund almost $250,000.
By Nick Paul Taylor • Jan. 04, 2019 -
Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018
Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.
By Maria Rachal • Dec. 22, 2018 -
OIG: Medicare contractor overpaid hospitals for radiation treatments
A review by the watchdog found that Medicare contractor National Government Services, Inc. overpaid hospitals millions of dollars for a type of advanced radiation procedure.
By Susan Kelly • Dec. 18, 2018 -
Texas judge rules ACA unconstitutional
The end of the Affordable Care Act would kill the medical device tax, but the ruling will almost certainly be appealed to a higher court.
By Tony Abraham • Dec. 14, 2018 -
Grand jury indicts physician over alleged medical testing fraud
The indictment came days before the government settled a separate fraud case with an audiology practice.
By Nick Paul Taylor • Dec. 13, 2018 -
Boston Scientific scores US victory in TAVR patents battle
A jury in the U.S. District Court for Delaware determined that the Sapien 3 device from Edwards Lifesciences infringed a Boston Scientific patent in the hotly contested transcatheter aortic valve replacement systems market.
By Maria Rachal • Dec. 12, 2018
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