Flowonix earlier this month warned about a software anomaly with its Prometra infusion pump that could unexpectedly shut down the device. The Budd Lake, N.J.-based company won FDA approval in February for updated software included in the Prometra system, which is indicated for intrathecal infusion of drug therapy, including infumorph, saline and baclofen. Flowonix warned […]
Nevro beats the Street with Q2 results
Shares in Nevro (NYSE:NVRO) rose this week after the medical device maker topped expectations on Wall Street with its second-quarter financial results. The Redwood City, Calif.-based company posted a net loss of -$28 million on sales of $93.6 million for the three months ended June 30. Compared with the same period last year, Nevro’s revenue fell […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective on […]
5 Wearable Technologies Conference exhibitors you should know
The 34th edition of the Wearable Technologies Conferenceseries is taking place today and tomorrow in San Francisco. Co-located with Semicon West, the Wearable Technologies Conference offers a number of panels to discuss wearables in healthcare and IoT, as well as conference exhibitors and networking opportunities. Here are five companies touting their latest wearable technologies at this […]
Boston Scientific gets in on $75m round for Saluda Medical
A day after taking out a loan from Medtronic (NYSE:MDT), Saluda Medical brought in $75 million with an equity round joined by Boston Scientific (NYSE:BSX). Australia- and Bloomington, Minn.-based Saluda said Redmile Group and “one other financial institution” participated in the round. Yesterday the company took out a four-year term loan from Medtronic for an unspecified amount, marking […]
Saluda Medical wins another investment from Medtronic
Saluda Medical said today that it took out a four-year term loan from Medtronic (NYSE:MDT) for an unspecified amount, marking the medtech titan’s third investment in the spinal cord stimulation device maker. In May 2017, Australia- and Bloomington, Minn.-based Saluda raised nearly $40 million for the Evoke closed-loop neuromodulation device it’s developing to treat axial […]
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 […]
Boston Scientific closes $465m Vertiflex buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $465 million buyout of spinal implant maker Vertiflex. The deal, announced last month, includes commercial milestones spaced out over three years. Carlsbad, Calif.-based Vertiflex makes the Superion decompression device for treating lumbar spinal stenosis, which won pre-market approval from the FDA in May 2015. Boston Scientific said […]
FDA permits marketing of pain relief device for kids with IBS
The FDA reported last week that it permitted marketing of the first medical device to reduce functional abdominal pain in patients ages 11-18 with irritable bowel syndrome. The U.S. regulatory body said the IB-Stim device, made by Innovative Health Solutions, could be used by this patient population when combined with other IBS therapies. The device […]
Saluda Medical touts Evoke closed-loop SCS studies
Saluda Medical today released data from two studies of its Evoke ECAP-controlled closed-loop spinal cord stimulator. The Evoke SCS system is designed to measure the spinal cord’s response to stimulation and adjust on every pulse to maintain activation within the patient’s therapeutic window, the Australian company said. Results from both the Evoke and Avalon studies […]
Boston Scientific gets into spine with $465 Vertiflex buy
Boston Scientific (NYSE:BSX) moved into the orthopedics space with a $465 million buyout of spinal implant maker Vertiflex. The deal, announced this morning and expected to close late in the second quarter of 2019, includes commercial milestones spaced out over three years. Carlsbad, Calif.-based Vertiflex makes the Superion decompression device for treating lumbar spinal stenosis, which […]
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