Dexcom (NSDQ:DXCM) posted second-quarter results this evening that beat the consensus forecast on Wall Street, and raised its outlook for the rest of the year. The San Diego–based continuous glucose monitoring (CGM) technology company reported a loss of $10.5 million, or $0.12 per share, on sales of $336.4 million for the three months ended June 30. […]
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. The 510(k) clearance covers three Vistaseal […]
Diabetes patients could soon replace fingersticks with Senseonics implantable CGM
Senseonics (NYSE:SENS) recently announced that the U.S. FDA has approved using the Eversense implantable continuous glucose monitoring (CGM) system as a replacement for fingersticks. Officials at the Germantown, Md.–based medical device company described the FDA approval for the non-adjunctive indication (dosing claim) as a major milestone. The company will make a new app available in coming months […]
7 MD&M East exhibitors you need to know
MD&M East is one of the largest medical device manufacturing events on the East Coast. Its organizer Informa Markets expects more than 8,000 advanced manufacturing professionals at this year’s event – June 11–13 in New York City. A show such as MD&M East allows officials from medtech companies large and small to network with the constellation […]
Contracting drug delivery device development: 5 things you need to know
AdrenaCard Pharmaceuticals is a Minneapolis-based startup developing what it touts as a small, easy-to-use epinephrine injector. As with many young medical device companies, it’s founders have had to rely on contracted talent. AdrenaCard’s CTO Chris Kuehn had a few tips and lessons learned to share this morning at the Design of Medical Devices Conference at […]
ProMed Pharma, DSM partner to use polymers to deliver drugs
ProMed Pharma and DSM Biomedical recently announced a business development partnership focused on polymeric drug delivery. The collaboration combines ProMed’s micromolding and extrusion capabilities in conjunction with DSM’s biomedical polyurethanes, polyurethaneureas, and bioerodible amino acid-based polyesteramides. Get the full story on our sister site Medical Design & Outsourcing.
West turns to Swissfillon for clinical filling of SmartDose drug delivery platform
West recently announced that it is forming a partnership with Swissfillon AG in which Swissfillon will provide fill-finish capabilities to customers using West’s proprietary SmartDose drug delivery platform. The partnership, which West announced last month at PharmaPack 2019 in Paris, will enable West to deliver filled Daikyo Crystal Zenith cartridges for the SmartDose wearable injector. […]
Phillips-Medisize is offering connected health data services: Here’s how
One of the world’s largest medical device contract manufacturers, Phillips-Medisize is making a business play to provide the technological back end for connected drug delivery devices. Phillips-Medisize used to be all about the housings, assembly and packaging that went into finished drug-delivery devices. Electronics was something that other contract manufacturers did. Within a few years, […]
Phillips-Medisize is expanding in Wisconsin
Phillips-Medisize, a Molex company, has broken ground on a new manufacturing facility in Hudson, Wis., on the eastern end of the Minneapolis-St. Paul metro area. The 34-acre location at the St. Croix Meadows development will support at least 230,000 square feet of manufacturing space for FDA-regulated medical device products, Phillips-Medisize announced yesterday. After construction is complete […]
Senseonics extends distribution agreement with Roche Diabetes Care
Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care. The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 […]
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