Hensler Surgical (Wilmington, N.C.) filed a patent infringement lawsuit yesterday accusing competitor Tobra Medical of infringing a newly-issued patent for an orthopedic surgery device. Filed in U.S. District Court for the Southern District of North Carolina, the lawsuit alleges that Tobra founder and president Bradford Collins contacted Hensler in early 2017 and expressed interest in […]
House bill asks CMS to cover breakthrough devices for Medicare patients
U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and […]
EPA moves closer to stricter regulation of medtech ethylene oxide sterilization
The Environmental Protection Agency yesterday asked the commercial ethylene oxide (EtO) industry, which includes medical device sterilizers, for input on next year’s updated regulation of emissions of the carcinogenic gas. Specifically, the EPA is requesting comment on available control technologies for reducing EtO emissions and on developments in practices, measurement, monitoring, processes and control technologies for the […]
Edwards projects $5 billion in sales for 2020
Wall Street expressed brief unhappiness with projections made at today’s Edwards Lifesciences (NYSE:EW) annual investor conference in New York, but shares had recovered partially by the close of trading. The Irvine, Calif.-based heart valve replacement pioneer projected adjusted EPS of $6.05 to $6.30 on global sales of $4.5 billion to $5 billion for 2020. Edwards […]
The best places to work for medtech sales reps
Teleflex (NYSE:TFX), ConMed (NSDQ:CNMD) and Precision Medical top the list of best places to work in medical device sales in the coming year, according to a MedReps.com survey of medical sales representatives. MedReps surveyed more than 1,200 medical sales professionals to get a better understanding of what employees look for in employers and how satisfied they […]
J&J’s Ethicon gets to substitute 20 new claims on surgical stapler patent
Johnson & Johnson (NYSE:JNJ) may file new claims in a surgical stapler patent case brought by Intuitive Surgical (NSDQ:ISRG) against J&J’s Ethicon unit. The original patent was granted in 2015. Ethicon sued Intuitive in Delaware in 2017, alleging that with the EndoWrist stapler Intuitive developed for its da Vinci robot-assisted surgery platform, Intuitive violates seven Ethicon […]
New study touts positive long-term results for Boston Sci’s Watchman
A long-term followup study on Boston Scientific’s (NYSE:BSX) Watchman heart implant shows low risk of hemorrhagic stroke and a high percentage of patients who discontinued anticoagulation drugs at one year. Published this week in the Journal of the American College of Cardiology, the new registry data represent the largest number and longest follow-up of patients […]
TransMedics touts first U.S. ‘reanimated’ heart transplants
TransMedics (NSDQ:TMDX) announced today that the doctors at two hospitals performed the first U.S. heart transplants using donor hearts that were resuscitated using the company’s organ care system (OCS). The transplants from donation after circulatory death (DCD) took place at Duke University Hospital in Durham, N.C. and Massachusetts General Hospital in Boston. In a DCD procedure, […]
Viant to cease ethylene oxide sterilization at Michigan plant by year’s end
Viant Medical has signed a consent order to stop sterilizing medical devices using ethylene oxide (EtO) at its plant in Grand Rapids, Mich. by Dec. 31, 2020, according to the Michigan Department of Environment, Great Lakes, and Energy (EGLE). Viant also agreed to stop using ethylene oxide (EtO) at the plant by Jan. 31, to conduct monthly air […]
Senate committee favors Hahn for FDA chief
A Senate panel has recommended approval of Dr. Stephen Hahn as the new commissioner of the FDA. The U.S. Senate Committee on Health, Education, Labor & Pensions voted 18 to 5 to approve the nomination of Hahn, the chief medical officer at Houston’s M.D. Anderson Cancer Center. Hahn would replace acting commissioner Dr. Brett Giroir, […]
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among […]