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 catheters. ViewFlex catheters are used in EP labs to help visualize cardiac anatomy and physiology. The clearance will add more diagnostic, EP-specific device, ultrasound and mapping catheters the company’s current line of products.
4. QT Medical wins FDA nod for home-use ECG
QT Medical has received FDA 510(k) clearance for its home-use 12-lead ECG device, according to a May 4 press release. The device can be used at home by a patient to perform a hospital-grade ECG scan of their heart that is sent through a cloud-based system to a physician for evaluation. When patients are experiencing symptoms following coronary artery bypass surgery or placement of a coronary stent, they can use the QT ECG to connect with their cardiologists in real time where the doctor can diagnose and prevent costly emergency room visits.
5. FDA clears PeraHealth’s clinical surveillance tech
PeraHealth announced in a May 3 press release that it has received FDA 510(k) clearance for its clinical surveillance technology, PeraTrend. PeraTrend is powered by the Rothman Index, which is a measure of a patient’s condition for healthcare providers. It allows hospitals to leverage data within an existing electronic health record to quantify and visualize patient deterioration, risk and improvement in real time.
6. Exact Imaging wins FDA nod for FusionVu
Exact Imaging has received FDA 510(l) clearance for its FusionVu application, according to a May 3 press release. The FusionVu is part of the ExactVu micro-ultrasound system that allows urologists to perform cognitive fusion through Cognitive Assist or micro-ultrasound/MR fusion on the ExactVu high-resolution platform.
7. Conavi wins FDA nod for Novasight hybrid system
Conavi announced in a May 1 press release that it has received FDA 510(k) clearance for its Novasight Hybrid System. The System allows for simultaneous imaging of coronary arteries with intravascular ultrasound and optical coherence tomography. Both imaging methods are used by interventional cardiologists to image coronary anatomy during angioplasty and stunting procedures.