News & Analysis as of

Food and Drug Administration (FDA) Medtronic

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

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Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Benesch

Dialysis & Nephrology Digest - August 2022

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DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more

Knobbe Martens

Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN

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Medtronic  announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic...more

Nutter McClennen & Fish LLP

Product Liability 2021 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows...more

Patrick Malone & Associates P.C. | DC Injury...

Risky heart pump shows how FDA fails patients on medical device regulation

The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Faegre Drinker Biddle & Reath LLP

California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal...

Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer,...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #197 — Medtronic 508 (MiniMed) Insulin Pumps Recalled

In my 25 years in the data privacy and cybersecurity profession, this is the first time that I believe a medical device has been recalled because of a cybersecurity risk. This week, Medtronic recalled its 508 Insulin pumps...more

Knobbe Martens

Medtronic Launches Deep Brain Stimulation Clinician Programmer for Use with Samsung Tablet

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Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is...more

Knobbe Martens

Medtronic Receives Regulatory Approval for Surgical Navigation Device

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According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more

Knobbe Martens

Medtronic's Recent Interactions with the FDA

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It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more

Knobbe Martens

FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

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Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary...more

Knobbe Martens

“World’s Smallest Pacemaker” Experiences Sizeable Success

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Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples...more

McDermott Will & Emery

Arm’s Length Royalty Rates Save Medtronic from $1.36 Billion Tax Deficiency

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Addressing whether certain intercompany technology license agreements were negotiated at arm’s length, the US Tax Court rejected the Internal Revenue Service’s (IRS’s) alleged $1.36 billion tax deficiency and determined that...more

Knobbe Martens

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

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The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven...more

Cooley LLP

Blog: Senator Calls on Med Device Leaders to Improve Cybersecurity

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Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in...more

Knobbe Martens

Medtronic Launches FDA-Cleared OsteoCool RF Ablation System

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According to Medtronic, the OsteoCool RF Ablation System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and they are launching the device in the United States. However, this news may not be...more

Carlton Fields

Food for Thought: Ninth Circuit Holds Cosmetic Labeling Claims Not Preempted by FDCA, Primary Jurisdiction Appropriately Invoked

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In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...more

Searcy Denney Scarola Barnhart & Shipley

Permanent Injunction Against Medtronic

The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s...more

Knobbe Martens

FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan

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Last week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic...more

Cooley LLP

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

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Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

Saul Ewing LLP

White Collar Watch - July 2014

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In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract ambiguity ...more

Saul Ewing LLP

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

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- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback Statute. ...more

Searcy Denney Scarola Barnhart & Shipley

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

Patrick Malone & Associates P.C. | DC Injury...

Medtronic Cardiac Guidewire Warning

The procedure to implant a cardiac stent, which keeps blocked arteries open, includes inserting guidewires to move the device into place. Federal health officials have issued a warning about a defect in some Medtronic...more

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