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An antitrust lawsuit filed Tuesday by Applied Medical Resources claims Medtronic uses anticompetitive bundling agreements to “illegally block” competition in the advanced bipolar energy device market.
The FDA issued a warning letter to Wintech Medipro for marketing its surgical masks without a premarket application or investigational device exemption and for several other lapses observed during an inspection of the company’s Katy, Texas facility.
Johnson & Johnson subsidiary Ethicon has agreed to pay the state of Kentucky $9.9 million to resolve allegations of deceptive marketing practices for Ethicon’s pelvic mesh surgical devices.
Just a day before a jury trial was set to begin, Alcon agreed to pay $199 million to J&J Surgical Vision to settle their intellectual property rights lawsuit over J&J’s laser-assisted cataract surgery software.
BlueStar Telehealth reported that its in-home remote patient monitoring program (RPM) using SmartMeter’s iBloodPressure cellular-connected blood pressure devices saw improvements in all patients with uncontrolled hypertension.
Insulet has completed two asset purchases that should about double the Massachusetts-based company’s portfolio of pump and automated insulin delivery (AID) technologies.
Devicemakers still using a paper-based quality management system (QMS) should seriously consider adopting an electronic QMS, advised compliance expert Sundeep Agarwal, in a recent FDAnews webinar.