Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. The company’s investigational product is a bioresorbable hydrogel fiber implant formulated with a […]
Hygieia wins FDA clearance for insulin management app
Hygieia said today that it won 510(k) clearance from the FDA for its insulin management app designed to optimize insulin dosing among people with Type 2 diabetes. The Michigan-based company touted its product as the first insulin management mobile app that can titrate individualized doses for all types of insulin regimens. It’s also the first […]
AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019
WTWH Media and MassDevice.com announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices […]
Cash-strapped Aradigm declares bankruptcy
Aradigm Corp. (NSDQ:ARDM) announced last week that it’s officially declaring bankruptcy. Strapped for cash, the Calif.-based company resigned to filing for Chapter 11 protection after it couldn’t confirm funding from its primary investor and partner, Grifols. “Aradigm intends to commence a process to sell substantially all of its assets to an interested party, subject to Bankruptcy […]
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five […]
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan‘s (NSDQ:MYL) brand-name emergency allergy device has dominated the markets. But the company faced widespread criticism in 2016 when reports revealed that Mylan hiked the price of the […]
Medtronic wins FDA’s breakthrough status for closed-loop insulin system
Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system. The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion. Medtronic’s November acquisition of nutrition data science company Nutrino Health will play a role in the development of its […]
Senseonics partners to provide veterans with Eversense CGM
Senseonics (NYSE:SENS) this week announced that it partnered with Geo-Med to provide access to the Eversense continuous glucose monitor to more than 9 million veterans and U.S. government staff. The company’s Eversense device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. The system includes a […]
Tandem wins interoperable claim for insulin pump from FDA
The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps. The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose […]
Ocugen wins orphan drug status for ocular gene therapy
The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease. The Malvern, Penn.-based company’s OCU400 product includes an adeno-associated virum serotype 5 capsid that contains the gene for human nuclear hormone receptor NR2E3. In a mouse model of NR2E3 mutation, delivery of NR2E3 to retinal […]
