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Lumendi

Report: Amazon adds MGH cardiologist Majmudar | Personnel Moves – August 21, 2018

August 21, 2018 By Fink Densford

Amazon (NSDQ:AMZN) has picked up well-known cardiologist Dr. Maulik Majmudar for a new role within the company as it looks to continue its foray into healthcare, according to a recent CNBC report. The announcement was made by Majmudar himself on Twitter, according to the report, though he did not state what his specific role within the […]

Filed Under: Business/Financial News Tagged With: Abbott, Amazon, BioCardia, BioSig Technologies, Endologix, Johnson and Johnson, Lantheus, Lumendi, Nuvasive, Personnel Moves, Philips, Rox Medical, SetPoint Medical, Steris Corp., Xtant Medical

Lumendi wins CE Mark, launches DiLumen EIP in EU

July 17, 2018 By Fink Densford

Lumendi said today it launched its DiLumen endolumenal interventional platform endoscope sleeve after winning CE Mark approval in the European Union for the device. The Buckinghamshire, U.K.-based company said its DiLumen EIP is a non-sterile, single-use sleeve designed to fit over standard endoscopes to stabilize the devices in the large intestine. Lumendi touted that the device […]

Filed Under: Business/Financial News, Endoscopic, Regulatory/Compliance Tagged With: Lumendi

Lumendi wins FDA nod for DiLumen IS endoscopic scissors

May 29, 2018 By Fink Densford

Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures. The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen […]

Filed Under: 510(k), Endoscopic, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Lumendi

7 medtech stories we missed this week: April 27, 2018

April 27, 2018 By Danielle Kirsh

From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed […]

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Hospital Care, Implants, Regulatory/Compliance, Surgical, Weight loss Tagged With: Abbott, Apollo Endosurgery, cerusendovascular, depuysynthes, Lumendi, MedTech, Pavmed, ReShape Lifesciences, sanquin

Lumendi wins FDA 510(k) for DiLumen endoscope positioning accessory

December 13, 2016 By Fink Densford

Medical device developer Lumendi said today it won FDA 510(k) clearance for its DiLumen endoscopic accessory. The Connecticut-based company’s DiLumen device is now indicated for use in positioning endoscopes in Treatments for IBS and assisting with optical visualization, diagnosis and endoscopic treatment. This most often occurs when the colon can’t pass or move stools through […]

Filed Under: 510(k), Endoscopic, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Lumendi

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