Tele: 561.316.3330
Breaking Medical Device News

Wednesday, October 20, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeSensile MedicalFirst US FDA Submission of Wearable Drug-Device Combination Product Based on Sensile...

First US FDA Submission of Wearable Drug-Device Combination Product Based on Sensile Medical’s SensePatch Drug Delivery Technology

This represents the first regulatory submission in the United States for Sensile Medical’s SensePatch technology as a combination product with scPharmaceuticals’ Furosemide for use in the United States.

Per the company, the NDA for the combination product of a novel furosemide formulation and sc2Wear Infusor™ based on the SenseCore micro pump technology was submitted in August and has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date of June 23, 2018.

On the NDA submission and FDA acceptance, Derek Brandt, CEO of Sensile Medical comments, “The NDA submission and FDA acceptance of the filing of this large-volume innovative drug-device product represents an important milestone for Sensile Medical and for the emerging market of wearable drug delivery devices.”  He concluded, “The lessons learned during the design and development process position us well to pursue this platform across a broad range of therapeutic segments and uses.”

The Company Describred the Advantages of Subcutaneous Drug Delivery Using Sense Core Technology:  Slow and controlled subcutaneous drug delivery is often therapeutically equivalent to intravenous (IV) or intramuscular (IM) drug administration. Contrary to IV or IM drug administration, subcutaneous delivery is something patients or lay caregivers can usually do in the comfort of their home. This enables novel, hospital-strength treatment options for home use.

Sensile’s unique SenseCore micro-pump technology powers a new generation of large volume devices as well as pumps for very exact small volume delivery. The SenseCore allows for a first of its kind device design that uses a reusable motorized component and disposable cartridges. This design minimizes waste and creates cost-effective treatment options unattainable by other device technologies.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy