Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes. The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce […]
7 medtech stories we missed this week: June 22, 2018
From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in […]
Apollo Endosurgery prices $21m offering
Apollo Endosurgery today priced a stock offering worth nearly $21 million for its line of bariatric and gastrointestinal devices. Austin, Texas-based Apollo said it plans to float roughly 3.75 million shares at $5.50 apiece, for gross proceeds of $20.6 million. The offering also includes a 45-day option for underwriter Craig-Hallum Capital of another 562,055 shares, […]
Bronchoscopes still dirty after cleaning, study says
A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged. “The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and […]
7 medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
Lumendi wins FDA nod for DiLumen IS endoscopic scissors
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 […]
Auris Health, Ethicon’s NeuWave ink robot-assisted bronchoscope ablation dev deal
Auris Health, previously known as Auris Surgical Robotics, said today it inked a cooperative development and commercialization deal with Johnson & Johnson (NYSE:JNJ) division Ethicon’s NeuWave Medical subsidiary looking to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions. Through the agreement, both companies will help develop an integrated system for robotic control, navigation and […]
Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract. The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend […]
Merit Medical gets in on NinePoint’s NvisionVLE OCT
NinePoint Medical said today that it inked a long-term deal with Merit Medical (NSDQ:MMSI) division Endotek to distribute its NvisionVLE optical coherence tomography device that includes strategic investment of an unspecified amount. “NinePoint Medical is committed to providing GI physicians an elegant and cost-effective OCT imaging solution to enable early and accurate diagnosis,” president & CEO Christopher […]
Olympus inks endoscope image sharing deal with InterSystems
Olympus (TYO:7733) said yesterday it inked a deal with InterSystems to enhance Olympus’ Knowledge Exchange System with InterSystems HealthShare, which allows for the sharing of images taken during endoscopy procedures. Olympus said its KE system is a software platform for centralized reprocessing record and image management that connects to its Olympus devices. The company added the […]
FDA warns against endoscope connectors
The FDA yesterday warned healthcare providers against using endoscope connectors in more than one patient without reprocessing, saying it hasn’t seen any acceptable tests demonstrating their safety. The federal safety watchdog said the connectors, which are used in more than one patient for gastrointestinal endoscopies over the course of 24 hours, connect the endoscope to […]
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