7 medtech stories we missed this week: May 11, 2018

[Image from unsplash.com]From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of the Therapeutic Products Directorate in Canada to amend its existing Canadian medical device license to include distribution of the ReShape Balloon and its accessories. The ReShape Balloon is FDA approved and is a non-surgical weight loss procedure that uses advanced balloon technology that takes up room in the stomach to help people with high body mass index. 2. FDA clears BrainsWay’s deep TMS stimulator for depression BrainsWay has received FDA 510(k) clearance for its new stimulator that is used in its Deep Transcranial Magnetic Stimulation (Deep TMS) system to treat major depressive disorder, according to a May 6 press release. The stimulator enhances the Deep TMS system and features BrainWay’s H-Coil helmet to reach deeper and larger surface areas of the brain than standard TMS treatments. 3. Innovative Health wins FDA nod for Xtra DX ultrasound cath Innovative Health announced in a May 7 press release that it has received FDA clearance to reprocess its ViewFlex Xtra Diagnostic Ultrasound Catheter. The clearance allows the company to develop a full suite of catheter...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Hospital Care Imaging mHealth (Mobile Health) Neurological Patient Monitoring Regulatory/Compliance Brainsway Conavi Exact Imaging innovativehealth MedTech PeraHealth qtm Source Type: news