Neurovascular bioelectronics medicine company Synchron Inc. has received good news in the form of a breakthrough device designation for its Stentrode. The U.S. FDA granted the designation for the fully implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel. As a bonus for patients, the device does not require open brain surgery. “As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces,” said Thomas Oxley, CEO of Synchron. Read More
The Court of Justice for the European Union (CJEU) has invalidated the EU-U.S. Privacy Shield, a mechanism designed to ensure the privacy of EU citizens’ data when conveyed to other nations in a manner consistent with the EU’s General Data Protection Regulation (GDPR). Makers of drugs and devices are not without recourse in transferring patient data to the U.S. for clinical trials conducted in Europe, but industry must revisit their standard contractual clauses to ensure those protocols provide the necessary privacy provisions, or face fines that could amount to tens of millions of euros. Read More
GI Windows Corp. scooped up $16.4 million in a series A-1 financing that included investment from Johnson & Johnson Innovation – JJDC Inc., Sonder Capital, GT Healthcare, JC Investco and an unnamed strategic investor. Also participating in the round were new investors Kennedy Trust and Coleman Trust. The funds are earmarked to advance the development and clinical trials of the company’s incisionless anastomosis technology. Read More
Pooled testing was hailed early in the COVID-19 pandemic as a way to quickly and efficiently increase the number of people tested for the virus. But the approach has fallen short of its promise for a variety of reasons, from supply and labor shortages to high community infection rates. Now, a new testing method – recently approved for use by laboratories in Israel – could help chip away at some of those issues. Read More
Generex Biotechnology Corp.’s wholly owned subsidiary Nugenerex Health partnered with Worldwide Digitech (WWDT) LLC to create a 50/50 joint venture, Nugenhealth LLC. The new company will draw on WWDT’s software to develop an end-to-end software-as-a-service (SaaS) solution for chronic care management using remote patient monitoring. Read More
TORONTO – After four years of relying on Vivametrica Inc. to successfully boost the health and wellness of its clients’ employees, Sprout Wellness Solutions Inc. has taken the next logical step by acquiring the Calgary-based health analytics company. Read More
With COVID-19, questions about how infections cause lasting immunity, or don’t, and how you know and what it all means for vaccines have become a matter of public focus. But some immunologists have been pondering those questions for years. “The immune system has a very good memory,” Bali Pulendran told BioWorld. “Clearly, some viruses and some pathogens can enter the body and stimulate the immune system, and the immune system can remember that encounter for decades.” Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Synchron. Read More
Keeping you up to date on recent developments in neurology, including: Blood-based test used to predict who is likely to develop psychotic disorders; Study could lead to more personalized choices for OCD treatment; Nerve cells differ before birth in people with ASD. Read More
