Legal: Page 2
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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 -
Bipartisan bill introduced in Senate to penalize Medicaid gaming
The incoming leaders of the Senate Finance Committee want to set monetary penalties for companies that misclassify products within Medicaid.
By Andrew Dunn • Dec. 05, 2018 -
Medtronic subsidiary to pay $17.9M in DOJ settlement
Following a federal probe, Medtronic-owned medical device company ev3 pleaded guilty to charges related to marketing a neurovascular medical device for unproven and potentially dangerous uses.
By Maria Rachal • Dec. 05, 2018 -
ACLA appeals lab payment suit to higher court
A watchdog report on Medicare lab payments will not help the industry's case, analysts said.
By David Lim • Dec. 05, 2018 -
HHS outlines broad plan to reduce EHR burden
The 74-page draft strategy, required by the 21st Century Cures Act, focuses on reducing time and effort tied to regulatory reporting requirements and increasing functionality and user-friendliness of EHRs.
By Meg Bryant • Nov. 29, 2018 -
Deep DiveWhy political contributions linked to a little-known hearing aid firm topped medtech giants
Spending connected to Starkey Hearing Technologies surpassed Medtronic, Boston Scientific and Edwards Lifesciences during the 2018 election cycle.
By David Lim • Nov. 29, 2018 -
CVS-Aetna megamerger finalized
The total value of the acquisition, including assumption of Aetna's debt, clocks in at $78 billion. The union creates the second biggest private company by revenue after Walmart.
By Rebecca Pifer • Nov. 28, 2018 -
FDA pitches boosting 510(k) scrutiny, asks Congress for help
The agency wants to move away from device maker reliance on 510(k) predicate devices older than 10 years and gain new authority to quickly impose special controls.
By David Lim • Nov. 26, 2018 -
Telehealth laws inhibit widespread use in Medicare population, CMS says
The agency is taking steps to open up virtual care options in some alternative payment models, but use among fee-for-service beneficiaries is only 0.25%, according to a new report.
By Meg Bryant • Nov. 19, 2018 -
FDA plans to waive informed consent for some clinical trials
The change would enable sponsors to run certain minimal-risk studies without gaining consent from participants. FDA said Friday it will reopen the comment period on the proposed rule.
By Nick Paul Taylor • UPDATED: Feb. 22, 2019 at 9:21 a.m. -
AdvaMed pitches new Anti-Kickback Statute safe harbors
The trade group wants the carve-outs for value-based pricing, warranty and risk-sharing arrangements.
By David Lim • Oct. 30, 2018 -
Boston Scientific posts strong Q3 with 8.7% sales growth
Coming off a legal win in a patent battle with Edwards, the CEO held his cards close to the vest on next steps on the earnings call.
By David Lim • UPDATED: Oct. 25, 2018 at 10:15 a.m. -
FDA sets busy year-end medical device to-do list
Improving mammography quality, revamping the De Novo classification process and revising the definition of a medical device to exclude certain medical software are some of the agency's priorities.
By David Lim • Oct. 19, 2018 -
FDA boosts medical device cybersecurity coordination with Homeland Security
The DHS Office of Cybersecurity and Communications and FDA's device center will increase information sharing of potential and confirmed device vulnerabilities and threats.
By David Lim • Oct. 16, 2018 -
Congress expands Sunshine payment reporting rules
A bill expected to be signed by the president requires companies report payments to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.
By Nick Paul Taylor • Oct. 11, 2018 -
Top Democrats question FDA Pre-Cert program safety, statutory authority
Concern that the agency may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition.
By David Lim • Oct. 11, 2018
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