The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format. The agency issued two proposed rules today-one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting.
From Medical Design & Outsourcing
- October 2021 Issue: Women in Medtech How Hologic made a major pandemic pivot: CFO Karleen Oberton reflects on key decisions and turning points of the COVID-19 pandemic. Insulet CEO Shacey Petrovic is pumped up to launch Omnipod 5 Boston Scientific’s Meghan Scanlon forecasts the future of urology There is still a long way to go to close the gender… […]
- Study finds single-use bronchoscopes reduce hospital readmission rates by halfA study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half. The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities. He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days,… […]
- Medtronic hires social-media-minded chief medical officer for its gastrointestinal unitMedtronic (NYSE:MDT) today said it has hired Dr. Austin Chiang as the first chief medical officer of the medical device maker’s gastrointestinal business. Chiang is an assistant professor of medicine at Sidney Kimmel Medical College and director of the Endoscopic Bariatric Program at Thomas Jefferson University Hospital, both in Philadelphia. He holds a master’s degree… […]
- Boston Scientific settles patent dispute with Micro-Tech Endoscopy over hemostasis clipsBoston Scientific (NYSE:BSX) said yesterday that it has resolved its patent infringement litigation against Micro-Tech Endoscopy over hemostasis clips used in endoscopy procedures. Boston Scientific said it will grant a five-year, royalty-bearing license to Ann-Arbor, Mich.-based Micro-Tech for the patented hemostasis clip technology. The clips are applied to tissue or blood vessels to stop gastrointestinal… […]
- How vapor degreasing is helping to future-proof medical device reliabilityPrecision cleaning of electronic medical devices boosts reliability. Jay Tourigny, MicroCare COVID-19 has brought the importance of wearable and remote monitoring and diagnostic devices to the forefront. But these devices, with their intricate PCBAs (printed circuit board assemblies) must deliver reliable and consistent performance, particularly as they are often used in devices that are life-sustaining.… […]
- Freudenberg Medical launches SpeakFree HME valve for laryngectomy careFreudenberg Medical today announced the commercial launch of its Blom-Singer SpeakFree heat and moisture exchange (HME) hands free valve. The device is designed for people who have undergone a total laryngectomy, or the removal of a person’s larynx or voice box, resulting in loss of speech. Carpinteria, California-based Freudenberg Medical’s InHealth Technologies unit said its… […]
- Luminopia’s new FDA-approved therapy uses TV to treat lazy eye in kidsLuminopia announced today that it received FDA de novo approval for its prescription therapy for improving vision in children with lazy eye. Cambridge, Massachusetts-based Luminopia’s prescription Luminopia One holds indication for improvement in visual acuity in children between ages four and seven with lazy eye (amblyopia) associated with anisometropia and/or mild strabismus, having received treatment… […]
- Tessy Plastics has a deal for a new campus in New YorkTessy Plastics today said it has a deal to buy a three-building campus totaling about 1.5 million square feet in Webster, New York. The three buildings — 200, 210 and 214 at 800 Phillips Road, formerly owned by Xerox — are about an hour’s drive from Skaneateles, New York-based Tessy’s other facilities in Upstate New York. The… […]
- Diversity in medtech: Just 21% of executive roles are held by womenThe prevalence of women in corporate leadership positions within the medical device industry remains low, and the rate of increase is stagnant despite new initiatives to increase diversity in the industry. Just 21% of top executives at the world’s 100 world’s biggest medical device companies are women, according to an analysis of Medical Design &… […]
- Intuitive Surgical highlights supply chain risk, addresses Medtronic’s Hugo launchIntuitive Surgical executives today said delays and price increases are working their way through the medtech supply chain, likely resulting in higher production costs in the months ahead and the potential for delayed development and regulatory activity. “I don’t think I can say it’s getting better. It’s a difficult situation and will continue for some… […]
- Intuitive Surgical names new C-suite leaders, reports Street-beating Q3Intuitive Surgical (NSDQ:ISRG) today announced changes in the ranks of its senior leadership as the surgical robotics maker released Q3 results that exceeded expectations. Sunnyvale, California-based Intuitive launched two new functional organizations — Strategy and Growth, and Global Business Services — and named leaders who will take over effective Jan. 1. Dave Rosa, a 25-year… […]
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