Legal: Page 2
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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 -
ACLA lab payment lawsuit dismissed by judge
The clinical lab lobby had argued HHS did not collect data from a wide enough range of laboratories when establishing Medicare payment rates.
By David Lim • Sept. 24, 2018 -
OIG advisory opinion cracks door open for device bundle warranties
The guidance comes as HHS awaits feedback on ways to improve the Anti Kickback Statute to ease obstacles to coordinated or value-based care.
By David Lim • Sept. 21, 2018 -
US wins kickback case against clinical lab Calloway
Calloway Laboratories is on the hook for $1.3 million for submitting false claims to Medicare and other federal healthcare programs.
By Nick Paul Taylor • Sept. 21, 2018 -
Trump signs NIST cybersecurity bill in bid to help small businesses
The law requires NIST to provide cybersecurity resources for small businesses within one year.
By Alex Hickey • Aug. 16, 2018 -
UnityPoint's second data breach this year could prompt expanded lawsuit
The Des Moines-based nonprofit notified 1.4 million people last week that a phishing attack may have compromised their information.
By Meg Bryant • Aug. 08, 2018 -
UK regulators reassure medtech sector about Brexit impact
The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.
By Nick Paul Taylor • Aug. 07, 2018 -
Industry urges Congress to ease clinical lab pay cuts
The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.
By David Lim • Aug. 03, 2018 -
Tendyne investors sue Abbott over lost milestone payment
After the success of transcatheter aortic valve replacement therapy, device companies are now focusing efforts on minimally invasive procedures to replace the mitral valve.
By Susan Kelly • July 23, 2018 -
Maryland broadens hospital price transparency initiative
The Maryland Health Care Commission website helps consumers compare prices for common non-emergency procedures.
By Tony Abraham • July 20, 2018
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