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Acclarent Inc.

DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation

June 3, 2021 By Tom Salemi

Dr. Josh Makower quite possibly invented modern-day medtech innovation. In this interview, Makower shares his earliest inventions — kind of mind-blowing — and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this […]

Filed Under: Business/Financial News, Device Talks Podcasts, Featured, Special Content Tagged With: Acclarent Inc., DeviceTalks Weekly, iRhythm Technologies Inc., Medtronic, New Enterprise Associates, Rapid Medical, Stanford Biodesign

Ex-Acclarent execs fined $1.5M in off-label marketing case

January 14, 2021 By Chris Newmarker

There will be no prison time for the two former Acclarent executives convicted of federal misdemeanor charges related to marketing a sinus balloon catheter for unapproved uses. Former Acclarent CEO William Facteau will instead pay a $1 million fine, and the company’s ex-sales VP Patrick Fabian will pay $500,000, according to the sentence handed down […]

Filed Under: Featured, Food & Drug Administration (FDA), Legal News, Regulatory/Compliance Tagged With: Acclarent Inc., Johnson & Johnson

J&J’s Acclarent launches TruDi ENT nav system

May 3, 2018 By Fink Densford

Johnson & Johnson‘s (NYSE:JNJ) Acclarent said late last month it launched the TruDi real-time, three-dimensional navigation system designed for ENT procedures. Acclarent said that the first commercial procedures were performed with the device on April 16, after having previously won FDA 510(k) clearance. The TruDi system is an electromagnetic image-guided navigation system designed for endoscopic sinus […]

Filed Under: Business/Financial News, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Acclarent Inc., Johnson and Johnson

Ethicon, JNJ escape Acclarent whistleblower’s retaliation suit

September 21, 2017 By Fink Densford

Allegations from a former Acclarent sales rep claiming she was fired for submitting a false claims report were kept alive this week by a Massachusetts magistrate judge, but the same allegations against Acclarent parent companies Johnson & Johnson (NYSE:JNJ) and Ethicon were thrown out, according to a Law360 report. The former sales rep Melanie Lokosky claimed […]

Filed Under: Legal News Tagged With: Acclarent Inc., Ethicon, Johnson and Johnson

FDA puts Acclarent’s Aera Eustachian tube balloon in Class II

October 24, 2016 By Fink Densford

The FDA today said it reclassified Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent’s Aera Eustachian tube balloon to a Class II device. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated to open up a pathway for mucus and […]

Filed Under: Catheters, Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Acclarent Inc.

Big Pharma urges acquittal for ex-Acclarent execs

September 23, 2016 By Sarah Faulkner

Pharmaceutical giants including Bayer (ETR:BAYN) and Pfizer (NYSE:PFE) filed a motion backing ex-Acclarent executives William Facteau and Patrick Fabian, urging the Massachusetts federal court to acquit them of their misdemeanor charges. Former Acclarent CEO Facteau and ex-sales vice president Fabian were convicted in July on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into […]

Filed Under: Food & Drug Administration (FDA), Legal News Tagged With: Acclarent Inc., Medical Information Working Group

Acclarent wins FDA nod for Aera Eustachian tube balloon

September 16, 2016 By Fink Densford

Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said today that it won de novo clearance from the FDA for its Aera Eustachian tube balloon dilation system, designed to treat persistent Eustachian tube dysfunction. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the […]

Filed Under: Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: Acclarent Inc., Johnson and Johnson

Judge lifts bail, travel restrictions on ex-Acclarent execs

September 1, 2016 By Brad Perriello

A federal judge in Boston this week lifted the bail and travel restrictions imposed on a pair of former Acclarent executives who were acquitted of felony fraud charges in July. Former CEO William Facteau and ex-sales vice president Patrick Fabian were convicted on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into interstate commerce.” Facteau is […]

Filed Under: Legal News Tagged With: Acclarent Inc., Ear Nose & Throat (ENT), Johnson and Johnson, Personnel Moves

Acclarent launches Relieva Scout multi-sinus dilator

July 22, 2016 By Fink Densford

Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said Wednesday it is launching the Relieva Scout multi-sinus dilation system in the U.S. The Relieva Scout is designed to use balloon sinuplasty technology to confirm and dilate sinus openings in individuals with chronic sinusitis through a minimally-invasive procedure. “I’m always looking for new technologies that enable me to […]

Filed Under: Business/Financial News, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Acclarent Inc.

J&J’s Acclarent to pay $18m over off-label marketing charges

July 22, 2016 By Fink Densford

Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent will pay $18 million to resolve allegations over false claims submitted to Medicare and other federal health care programs in relation to marketing its Relieva Stratus MicroFlow sinus spacer as a drug-delivery device without FDA clearance. The company won FDA clearance in 2006 to market the Stratus as a […]

Filed Under: Drug-Device Combinations, Legal News Tagged With: Acclarent Inc., Johnson and Johnson

Ex-Acclarent CEO, sales VP escape felony charges, convicted on misdemeanors

July 20, 2016 By Fink Densford

UPDATED July 21, 2016, with verdict details, comment from defense lawyers. A federal jury today convicted 2 former Acclarent executives for the distribution of adulterated and misbranded medical devices, but acquitted them of the felony charges leveled in the case. Former CEO William Facteau and ex-sales vice president Patrick Fabian were convicted by a jury after […]

Filed Under: Legal News Tagged With: Acclarent Inc.

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