Glytec said today that it won a fourth 510(k) clearance from the FDA for its insulin titration software, eGlycemic Management System featuring Glucommander. The latest FDA nod applies to product enhancements derived from user feedback, the Waltham, Mass.-based company said, including a streamlined transition of inpatients from IV to subcutaneous therapy and more robust workflow capabilities. […]
Food & Drug Administration (FDA)
BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency […]
FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device
Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed […]
Senseonics expects FDA panel to consider Eversense CGM clearance
Senseonics (NYSE:SENS) said it expects the FDA will convene a special panel as it considers the company’s implantable Eversense continuous glucose monitors. The clarity came during the company’s 2nd quarter earnings call last week, with CEO Tim Goodnow saying the company expected the federal watchdog to look to an advisory panel, similar to its actions with Dexcom‘s (NSDQ:DXCM) […]
ImpediMed shares rise on FDA nod for Sozo system
Australian medtech developer ImpediMed saw shares rise as much as 9.7% after it said it won FDA 510(k) clearance for its Sozo bioimpedance spectroscopy platform. The Sozo system is designed to non-invasively measure and monitor fluid status and body composition using the company’s L-Dex lateral lymphedema assessment system. “We are delighted to receive this FDA clearance […]
7 medtech stories we missed this week: August 11, 2017
From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions […]
Renovis wins FDA nod for Tesera lumbar interbody fusion systems
Renovis Surgical Technologies said today it won FDA 510(k) clearance for its Tesera lumbar porous titanium interbody fusion systems. The Redlands, Calif.-based company said its newly cleared Tesera devices feature implants designed for direct posterior or transforaminal approaches, and includes straight and curved options in multiple heights, widths and lengths. The Tesera devices are produced […]
SteadyMed tops Q2 sales, EPS estimates
Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates. The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth of […]
Deaths prompt renewed FDA warning on intragastric balloons
UPDATED August 15, 2017, with comment from ReShape Medical. The FDA yesterday updated its warning of the risks associated with fluid-filled intragastric balloons after receiving new reports of the deaths of patients implanted with the devices. Intragastric balloons, made by Apollo Endosurgery (NSDQ:APEN) and ReShape Medical, are used to treat obesity. Placed in the stomach orally in a minimally […]
Study: Abuse-deterrent opioids are costly and unproven
In an attempt to curb the harrowing opioid crisis in America, drugmakers have developed what they tout as “abuse-deterrent” pain-killers – opioid formulations that are designed to prevent users from injecting the drugs. But a report published this week by the Institute of Clinical and Economic Review found that there isn’t enough evidence to claim that these […]
Ocular’s new CEO to ‘aggressively’ seek partnerships
Since the start of June, Ocular Therapeutix‘s (NSDQ:OCUL) stock price has fallen more than -45%. The company’s founder and chief executive, Amar Swahney, has stepped down, assuming the role of executive chairman, and the FDA has rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza. Amidst regulatory troubles, Ocular tapped former Mundipharma exec Antony Mattessich to serve […]