Attention-deficit hyperactivity disorder makes it harder for people to pay attention and control impulsive behavior. It is one of the most common neurobehavioral disorders in children, according to the CDC. The treatment options for ADHD include behavioral therapy and medication intervention, but what if kids could use video games to treat the disorder? Akili Interactive, […]
European regulators assign UDI issuing agencies
By Ronald Boumans, Emergo Group The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Global medical device regulatory trends
By Evangeline Loh, Emergo Group In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified themes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Edwards Lifesciences warns on risk of IntraClude balloon bursting
Edwards Lifesciences (NYSE:EW) issued a field safety notice warning users that its IntraClude balloon could burst during cardiopulmonary bypass. The high-risk balloon burst could cause injury, according to the company. When the balloon bursts, the heart can fill and warm and obscure the operative site. Edwards Lifesciences says the device needs to be exchanged or operate […]
FDA approves new MR-safe hearing device from Cochlear
Cochlear Ltd. (ASX:COH) today announced that it received FDA approval for its Cochlear Nucleus cochlear implant and its Nucleus 7 sound processor. The Nucleus Profile Plus implant is designed for safe use in MRI scans and offer easier access to 1.5 and 3.0 Tesla MRI scans without having to remove its internal magnet or use a […]
Dexcom plans Apple Watch CGM launch
Dexcom Inc. (NSDQ:DXCM) is reportedly launching upgrades for its G6 diabetes system and plans to launch its direct-to-Apple Watch version over the next year. The Apple and Dexcom collaboration would allow diabetes patients to track glucose through the Apple Watch, a consumer wearable, according to CNBC. Get the full story on our sister site, Drug Delivery Business […]
DHS warns again on cybersecurity flaw in BD Alaris workstations
The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]
Resonetics expands Medibrane investment
Resonetics (Nashua, N.H.) today announced that it is making an additional equity investment in and providing debt financing to Medibrane. The company took minority ownership of Israel-based Medibrane as part of its acquisition of STI Laser in November 2018. “Having worked with the founders at Medibrane for the past six months, we’ve grown increasingly excited […]
FDA clears CorMatrix Cardiovascular’s Cor heart tissue patch
CorMatrix Cardiovascular said it received FDA 510(k) clearance for its Cor Patch epicardial patch. The Cor Patch epicardial patch is designed to repair the atria and the left and right ventricular walls of the heart that are thin or damaged as a result of myocardial infarct. “We have a unique opportunity to enhance the repair […]
ReWalk Robotics raises $11m in warrants offering
ReWalk Robotics (NSDQ:RWLK) said yesterday that it raised $11 million in a warrants offering. Israel-based ReWalk Robotics sold roughly 1.5 million five-year warrants in November 2018 that are now being redeemed for $7.50 apiece, resulting in gross proceeds of $11 million and net proceeds of about $10 million. The warrants were issued on June 5-6, according […]
Nuvectra seeks another FDA nod for spinal cord stimulation system
Nuvectra said yesterday that it filed for expanded FDA approval of its Algovita spinal cord stimulation device. The Plano, Texas-based company asked the federal safety watchdog for full-body MR-conditional approval for the Algovita SCS. The device first received FDA premarket approval in 2015. “We believe full-body MR conditional approval in the U.S., in addition to Algovita’s […]