The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
Endoscopic
Erbe Elektromedizin to acquire Maxer Endoscopy
Erbe Elektromedizin announced today that it is set to acquire Maxer Endoscopy for an undisclosed amount. Teubingen, Germany–based Erbe Elektromedizin develops, manufactures and distributes surgical instruments and devices in almost all specialist areas. Combined with other Erbe technologies, the surgical instruments are based on electrosurgery. Tuttlingen, Germany–based Maxer specializes in a wide range of endoscopic […]
FDA flags infection risk from reusable urological endoscopes
The FDA said today that is looking into the causes of infections from reprocessed urological endoscopes based on “numerous” adverse event reports. The agency said that since 2017 it has received more than 450 medical device reports — including three deaths — associated with reprocessed cystoscopes, ureteroscopes and cystourethroscopes used for viewing and accessing the […]
8 medical device companies that beat the COVID-19 pandemic and prospered
Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread. Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was […]
Ambu single-use endoscope wins Frost & Sullivan innovation award
Frost & Sullivan today announced that it awarded Ambu with a 2021 Global New Product Innovation Award. Ambu received the award for its single-use flexible endoscopes that are designed to make the devices safe, affordable and accessible. It has aView and aBox all-in-one video displays that eliminate the traditional video endoscopy tower size and expense to be […]
PavMed to spin off subsidiary Lucid Diagnostics
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics will spin off into a separate public company. In a news release, Pavmed said Lucid Diagnostics intends to spin off if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation. […]
Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system
Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant […]
Smart Medical Systems wins additional FDA clearance for G-Eye colonoscope
Smart Medical Systems announced today that it received an additional FDA clearance for its G-Eye colonoscope. G-Eye, which is based on Fujifilm’s FDA-cleared colonoscopes, has FDA 510(k) clearance and is remanufactured by Smart to include a proprietary balloon at its distal bending section. The portfolio of colonoscopes includes selected models of endoscope brands including Fujifilm, […]
J&J, Boston Sci vet McKhann to become Apollo Endosurgery’s CEO
Apollo Endosurgery (NSDQ:APEN) announced today that Charles (Chas) McKhann will become its new CEO and join its board of directors. Current CEO Todd Newton will help facilitate the transition process and agreed to serve as a consultant to the company for up to six months following McKhann’s hire, which becomes effective on March 1, according to […]
Ambu expands single-use endoscopy contracts with GPOs
Ambu (CPH:AMBU-B) announced today that it has secured national single-use endoscopy contract expansions with two major U.S. group purchasing organizations (GPOs). Ballerup, Denmark–based Ambu is now on contract with all four major GPOs in the U.S. Customers served by the GPOs now have access to either a full or partial portfolio of single-use endoscopy categories. […]
5 innovations to make duodenoscopes more single-use — and save lives
Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. (Here are five of the innovations.) Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the […]
