Neurotechnology company Synapse Biomedical has received Humanitarian Device Exemption (HDE) marketing approval from the U.S. Food and Drug Administration for a diaphragm pacing system that helps certain types of patients suffering from amyotrophic lateral sclerosis with breathing. The approval means that Oberlin, Ohio-based Synapse can begin marketing and selling the device for a subset of […]
Cleveland Clinic neuromodulation spinoff Intelect Medical may have stealthily exited Cleveland to set up shop in Boston, but the company's recent $78 million sale to Boston Scientific (NYSE: BSX) highlights Northeast Ohio's growing strength in neurotechnology. Here's a brief overview of the key players in Northeast Ohio's rising neurotechnology industry.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A roundup of companies announcing regulatory clearances from the Food & Drug Administration and foreign regulatory agencies. Here’s a roundup of companies announcing regulatory clearances from the Food & Drug Administration and foreign regulatory agencies: Boston Scientific wins expanded CE Mark for WallFlex biliary stent Boston Scientific Corp. (NYSE:BSX) announced that its WallFlex Biliary RX […]
Synapse Biomedical Inc. in Oberlin, Ohio, has received Humanitarian Use Device approval from the Food and Drug Administration for its NeuRx Diaphragm Pacing System in certain ALS patients. The designation is a step toward getting a full-blown Humanitarian Device Exemption (HDE), for which Synapse Biomedical applied on Friday.
Dr. Raymond Onders will share a venture capital success story this week during his talk, "Helping Patients Breathe: From Superman to Synapse Biomedical -- How orphan diseases can lead to worldwide sales from Northeastern Ohio."
Synapse Biomedical Inc. has raised more than $433,000 from investors on its way to $1.2 million to repay debt and get ready to supply its diaphragm pacing technology to a new market: ALS patients.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.