Johnson & Johnson MedTech’s Acclarent business announced FDA 510(k) clearance for its TruDi shaver blade and its advanced navigation features. In a news release posted yesterday, Acclarent described TruDI as a single-use electromagnetically navigated blade. It’s used with the company’s Bien-Air S120 shaver for the incision and removal of soft and hard tissue or bone […]
Acclarent Inc.
DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation
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 […]
Ex-Acclarent execs fined $1.5M in off-label marketing case
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 […]
J&J’s Acclarent launches TruDi ENT nav system
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 […]
Ethicon, JNJ escape Acclarent whistleblower’s retaliation suit
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 […]
FDA puts Acclarent’s Aera Eustachian tube balloon in Class II
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 […]
Big Pharma urges acquittal for ex-Acclarent execs
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 […]
Acclarent wins FDA nod for Aera Eustachian tube balloon
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 […]
Judge lifts bail, travel restrictions on ex-Acclarent execs
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 […]
Acclarent launches Relieva Scout multi-sinus dilator
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 […]
J&J’s Acclarent to pay $18m over off-label marketing charges
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 […]
