Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster. The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, […]
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Wishbone Medical picks up pediatric device maker Response Ortho
WishBone Medical said this week that it acquired Turkish pediatric fixation device maker Response Ortho for an undisclosed amount. Istanbul-based Response’s portfolio includes 30 pediatric orthopedic systems; WishBone had eight before the acquisition, the Warsaw, Ind.-based company said. Eighteen of the Response Ortho products are cleared or approved for the U.S. market. Wishbone said it’s opursuing […]
Neural Analytics adds $10m for robot-assisted brain ultrasound
Neural Analytics yesterday reported raising nearly $10 million for the robot-assisted brain ultrasound device it’s developing. Los Angeles-based Neural Analytics’ NeuralBot is designed to work with its Lucid M1 transcranial doppler utrasound to provide non-invasive blood flow monitoring. In June the company won CE Mark approval in the European Union for NeuralBot. In a funding round begun […]
Eyenovia touts publication of intraocular pressure data for micro-dose tech
Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology. The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure. Get the full story at our sister site, Drug Delivery Business News.
Millar ends CD Leycom distribution agreement
Millar said today that it is discontinuing its exclusive North American distribution agreement with CD Leycom, maker of the clinical Inca pressure-volume (PV) loop system. Officials at Houston-based Millar – a pressure sensors and medical device contract manufacturing company – plan to focus more on the company’s OEM division, which integrates pressure sensors based on microelectromechanical systems […]
FDA delays some UDI compliance dates
Under pressure from manufacturers, the FDA is pushing back Unique Device Identification (UDI) compliance deadlines for some non-sterile, class I, and unclassified devices. Devicemakers will have until September 24, 2020 before they must comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements for these devices, according to the new […]
Teva launches generic EpiPen at the same price as existing device
Teva (NYSE:TEVA) this week launched its generic version of Mylan‘s (NSDQ:MYL) EpiPen auto-injector and announced that it would sell the emergency allergy therapy for $300 – the same price as Mylan’s own generic EpiPen product. The price for Teva’s product inspired some head-scratching among patient advocates and healthcare professionals. After all, when the FDA first approved Teva’s […]
CVS closes $70B Aetna buy
CVS Health (NYSE:CVS) said yesterday that it closed the $70 billion buyout of health insurer Aetna (NYSE:AET). When the deal was announced in December 2017, the chief executives of CVS and Aetna said that they plan to transform CVS’s pharmacies and clinics into community-based healthcare sites, where people can access care at a more reasonable price than for a […]
Cantel Medical’s fiscal Q1 earnings meet The Street, but sales miss
Fiscal first-quarter earnings for Cantel Medical (NYSE:CMD) equaled the consensus forecast on Wall Street, but the medical device company miss the mark with its top-line number. Little Falls, N.J.-based Cantel posted profits of $19.2 million, or 46¢ per share, on sales of $225.6 million for the three months ended Oct. 31, for a bottom-line slide of […]
Nexstim pulls trigger on 30-to-1 reverse split
Nexstim said this week it pulled the trigger on a 30-to-1 reverse split of its stock as the company looks to reduce its share capital. Through the move, each shareholder in the Helsinki, Finland-based company will receive a single share for every 30 shares they previously owned. The shift went into effect on Monday, with […]
Solaire Medical buys InnerSpace medical storage product lines
Solaire Medical (Marne, Mich.) said today that it has acquired the InnerSpace medical storage product lines from Stanley Black & Decker. Financial terms of the deal, effective Sept. 28, 2018, were not disclosed. The purchase has resulted in redesigned product lines branded as InnerSpace by Solaire Medical. It also triples Solaire Medical’s number of employees to 75. […]