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Chris Newmarker

J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant

June 19, 2019 By Chris Newmarker

Johnson & Johnson Ethicon Grifols

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Surgical Tagged With: Ethicon, Grifols, Johnson & Johnson

Diabetes patients could soon replace fingersticks with Senseonics implantable CGM

June 10, 2019 By Chris Newmarker

Senseonics - updated logo

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 […]

Filed Under: Business/Financial News, Diabetes, Featured, Food & Drug Administration (FDA), mHealth (Mobile Health), Regulatory/Compliance Tagged With: Senseonics

7 MD&M East exhibitors you need to know

June 7, 2019 By Chris Newmarker

MD&M East

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 […]

Filed Under: Contract Services, Drug-Device Combinations, Featured, Wound Care Tagged With: Freudenberg Medical, Freudenberg Performance Materials, MD&M East, Phillips-Medisize, West Pharmaceutical Services

Contracting drug delivery device development: 5 things you need to know

April 17, 2019 By Chris Newmarker

contracting drug delivery device development team teamwork

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 […]

Filed Under: Contract Services, Featured Tagged With: adrenacardpharmaceuticals, designofmedicaldevicesconference, devicetalksminnesota

ProMed Pharma, DSM partner to use polymers to deliver drugs

March 13, 2019 By Chris Newmarker

DSM ProMed

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. 

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations Tagged With: DSM, dsmbiomedical, promedpharma

West turns to Swissfillon for clinical filling of SmartDose drug delivery platform

March 13, 2019 By Chris Newmarker

West Pharmaceutical Services - updated logo

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. […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Pharmaceuticals Tagged With: swissfillon, west

Phillips-Medisize is offering connected health data services: Here’s how

February 20, 2019 By Chris Newmarker

Phillips-Medisize Connected Health Platform

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, […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Featured, mHealth (Mobile Health) Tagged With: Phillips-Medisize

Phillips-Medisize is expanding in Wisconsin

February 19, 2019 By Chris Newmarker

Phillips-Medisize Hudson 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 […]

Filed Under: Business/Financial News, Contract Services Tagged With: Phillips-Medisize

Senseonics extends distribution agreement with Roche Diabetes Care

February 4, 2019 By Chris Newmarker

Senseonics, Roche expand distribution deal for glucose monitor

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 […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: Roche, Senseonics

How Covestro polycarbonate is enabling syringe innovation

January 31, 2019 By Chris Newmarker

Gerresheimer AG Covestro Gx TELC tamper-evident luer lock safety seal

  Covestro officials are boasting how their Apec 1745 high heat polycarbonate was the material of choice for Gerresheimer AG’s new tamper-evident luer lock closure for syringes.   In the growing prefilled syringes market, the adapter for screwing in the needle and the syringe cap plays a key role when it comes to ensuring ease of use and reliable dosage, […]

Filed Under: Contract Services, Drug-Device Combinations, Technology Tagged With: covestro, gerresheimer, Gerresheimer AG

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