Centinel Spine said yesterday that it won an investigational device exemption from the FDA for a clinical trial of its Prodisc cervical disc implants. New York City-based Centinel acquired the Prodisc assets from Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes in December 2017 for an undisclosed amount. The FDA IDE covers a two-level study of the company […]
BrainsWay touts results of dTMS study for depression
BrainsWay (NSDQ:BWAY) said today that a study shows that deep transcranial magnetic stimulation (dTMS) plus standard medication was significantly more effective at reducing depression levels among major depressive disorder (MDD) patients than standard medication alone. Researchers at the Psychiatric Hospital Sveti Ivan in Croatia conducted the 228-patient randomized controlled study independent of industry support. The […]
Titan Medical on track for FDA, CE Mark bids this year
Titan Medical (TSX:TMD;OTC:TITFX) said today that it’s on track to submit approval bids this year for its Sport robot-assisted surgery device in the U.S. and Europe. The Toronto-based company said it completed all procedures under Good Laboratory Practices guidelines for acute and chronic animal and human cadaver studies, with slated to follow by the end of […]
Musk’s NeuraLink eyes 2020 human trials for brain implant
NeuraLink yesterday pulled back the curtain on the implant it hopes will wirelessly enable the human brain to control machines, reportedly including the robot-assisted implantation system it devised for its “neural lace” sensors, the sensors themselves and a chip designed to clean and amplify brain signals. The Elon Musk-backed company had previously only described its […]
Boston Scientific aims for personalized Parkinson’s therapy with Vercise DBS
Dr. Rafael Carbunaru and his team at Boston Scientific (NYSE:BSX) have spent the last twenty years building, among other things, the Vercise deep brain stimulation system in an attempt to deliver precise, personalized therapy for people with Parkinson’s disease. “It’s a labor of love,” the VP of R&D told MassDevice.com. Carbunaru estimated there are roughly 1.2 […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be assessed for […]
NeuroPace epilepsy tech to be studied for binge eating
NeuroPace said today that its epilepsy neuromodulation technology will be studied for its efficacy in treating binge-eating disorder in certain patients. The Mountain View, Calif.-based company’s RNS system is a closed-loop technology approved to treat adults with medically refractory focal onset epilepsy. The clinical trial will examine whether neuromodulation could help patients with a body […]
Teleflex touts large real-world UroLift study
Teleflex (NYSE:TFX) yesterday touted results from a real-world study of its UroLift system for treating prostate disease. The UroLift implant is designed to treat lower urinary tract symptoms from benign prostatic hyperplasia. Wayne, Pa.-based Teleflex paid $1 billion to acquire NeoTract, which developed UroLift, in October 2017. The 1,413-patient retrospective study was designed to evaluate UroLift’s […]
Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery. With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. […]
Study: Boston Sci’s Watchman cheaper than drugs long-term
Updated to include comments from the principal investigator. A new study has found that use of the Boston Scientific (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device to treat atrial fibrillation costs less than existing and novel anticoagulant drugs over five years. Researchers conducted the analysis using an Excel-based simulation model developed to assess the […]
Taris Biomedical touts results of bladder cancer treatment study
Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC). The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from both […]
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