Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. “Physicians are looking for a technology that is minimally invasive and also curative,” principal investigator […]
Curetis launches diagnostic cartridge for urinary tract infection
Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections. The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect […]
Medtech stories we missed this week: April 20, 2018
From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute […]
Sollis lands $50m for extended-release pain-relief drug
Sollis Therapeutics closed a $50 million round to support a pivotal trial of its non-opioid pain-reliever, according to Ohio-based translator NeuroTechnology Innovations Translator. Deerfield Management led the funding round and was joined by NIT collaborators, including Medtronic (NYSE:MDT), Cardinal Health and Ohio State University. NIT founded Sollis Therapeutics last year to help facilitate the development and commercialization […]
Qiagen wins FDA nod for point-of-care PartoSure test
Qiagen (NYSE:QGEN) today touted the FDA’s approval of its PartoSure diagnostic test, designed to assess the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The non-invasive strip test detects placental alpha microglobulin-1 and can provide results in less than five minutes, according to Germany-based Qiagen. Beyond the company’s U.S. regulatory win, PartoSure […]
Valeritas taps Glooko’s data management platform for next-gen insulin delivery device
According to a newly-inked deal between the two companies, Glooko plans to provide its diabetes data management platform to Valeritas (NSDQ:VLRX) for use with the medtech company’s next-gen V-Go insulin delivery device. Valeritas’ V-GO SIM device is an investigational accessory that the company said will snap onto its existing insulin delivery devices. The product is designed […]
Update: Allergan, Takeda spar for Shire
Hours after Allergan (NYSE:AGN) said it was considering an acquisition of Shire (NSDQ:SHPG), the Dublin-based company announced that it does not intend to make such an offer. Reports also surfaced today that Shire rejected a $63 billion takeover offer from Takeda Pharmaceutical (TYO:4502). Reuters, which first broke the news of Allergan’s interest in Shire, citing a pair of unnamed sources, […]
Senators urge HHS to seek lower price for naloxone
U.S. Sens. Debbie Stabenow (D-MI) and Gary Peters (D-MI) penned a letter to the Dept. of Health and Human Services, urging the agency to demand that manufacturers lower the price of the opioid overdose reversal drug, naloxone. The lawmakers wrote that the price of naloxone has climbed dramatically since it was first approved by the […]
Quest Diagnostics posts mixed Q1
Shares in Quest Diagnostics (NYSE:DGX) held steady today after the company met earnings expectations on Wall Street but missed analysts’ sales estimates with its first-quarter results. The Secaucus, N.J.-based company posted profits of $177 million, or $1.27 per share, on sales of $1.88 million for the 3 months ended March 31, for bottom-line growth of 7.9% […]
Pear Therapeutics, Sandoz ink deal for prescription digital therapeutics
Pear Therapeutics revealed yesterday that it agreed to deal commercialization rights of its digital therapeutics to Novartis (NYSE:NVS) division Sandoz. The company’s reSET substance use disorder therapy became the first prescription digital therapeutic approved by the FDA in September last year. reSET-O, a digital therapeutic designed for people suffering from opioid use disorder, is under review […]
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