The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis. More than 250 companies submitted entries to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, announced in May. Those selected include Masimo Corp. and deep-brain-stimulation company Brainsway Ltd. The companies will be expected to […]
Brainsway
BrainsWay wins ‘historic milestone’ clearance to treat OCD
BrainsWay said it has won de novo clearance from the FDA for its deep transcranial magnetic stimulation (Deep TMS) system for treatment of obsessive-compulsive disorder (OCD) in adults. The clearance marks the second indication granted for BrainsWay Deep TMS, and the first noninvasive medical device clearance for the treatment of OCD. The FDA cleared the device […]
Brainsway wins FDA nod for OCD-treating TMS system
The FDA today said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder. The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients. A 100-patient randomized, multi-center study of the device […]
7 medtech stories we missed this week: May 11, 2018
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 […]
Transcranial magnetic stim dev Brainsway raises $9m
Transcranial magnetic stimulation device developer Brainsway has raised $8.5 million, according to a report from Globes Israel. The round was joined by The Phoenix Holdings and IBI Investment House, which has an existing 8% stake in the company. Israel-based Brainsway is developing magnetic stimulation helmets for treating neurological and psychiatric disorders, according to Globes Israel. […]
Medtech funding for the week of Mar. 10, 2014
Brainsway raises $11.8M for neurological stimulation
Israeli stimulation devices maker Brainsway (PINK:BRSYF) raised about $11.8 million (NIS 41 million) thanks to a private placement investment from Yelin Lapidot Investment House.
Study: Experimental anorexia treatment with deep brain stimulation may provide lasting results
In what some are calling "a world 1st," researchers reported some success in treating severe anorexia patients via implanted electrodes that delivered electrical energy to the regions of the brain associated with emotion.
The study enrolled 6 patients to receive the experimental treatment, reporting that 3 of the 6 achieved weight gain and 4 of the 6 reported changes in mood, anxiety, control over their urges to binge and purge and other symptoms associated with anorexia.
Brainsway wins 6th CE Mark for Deep TMS to treat chronic pain | Regulatory Roundup
Medtronic lands Japanese approval for CoreValve trial | Regulatory Roundup
Medtronic (NYSE:MDT) implanted its CoreValve transcatheter aortic valve implantation system into the first patient in a Japanese clinical trial of the device’s safety and effectiveness.
The CoreValve system is a minimally invasive treatment option for patients with severe heart disease who are at high risk or unable to undergo open-heart surgery.
Brainsway wins Israeli nod for deep-brain stimulation device to treat depression | Regulatory Roundup
Brainsway Ltd.’s (PINK:BRSYF) transcranial magnetic stimulation device won Israeli Ministry of Health approval to treat major depression, bipolar disorder and negative impairment in schizophrenia patients.
The approval clears Jerusalem-based Brainsway to sell the non-invasive TMS device, which delivers brief magnetic pulses to the brain, to four medical centers specializing in mental disorders.