Beta Bionics’ bionic pancreas wins breakthrough status from FDA

December 11, 2019 By Nancy Crotti

The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system.

The approval covers all configurations of the device — insulin-only, glucagon-only, and bihormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution.

The iLet Bionic Pancreas System is a pocket-sized, wearable investigational medical device that is designed to autonomously control blood-sugar levels. The on-body wear is similar to that of an insulin pump. Unlike insulin pump therapy, however, the investigational system is designed such that users enter only their body weight for the iLet to initialize therapy. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

Get the full story on our sister site, Drug Delivery Business News.

Wytech Industries names new president
Specialty and precision wire manufacturer Wytech Industries (Rahway, N.J.) today announced it has named David Ohmann as president. Ohmann has nearly 25 years of experience in international, orthopedic and advanced surgical medical device segments. Prior to joining Wytech, Ohmann held sales and marketing leadership positions at Heraeus and MicroGroup (a TE Connectivity company). Ohmann has a… […]
Spectrum Plastics acquires Laser Light Technologies
Spectrum Plastics Group has announced the acquisition of substantially all assets of Laser Light Technologies. An ISO 9001- and ISO 13485-certified organization based in Hermann, Mo., Laser Light Technologies provides custom laser processing systems and services using excimer, femtosecond, picosecond and YAG laser technologies. “The addition of the talented team at Laser Light Technologies brings… […]
Dymax announces deal with coatings company
Dymax and nanocoatings manufacturer HZO today announced a strategic partnership. The deal will add 3,000 coatings formulations to HZO’s portfolio, facilitate joint product development, and use Dymax’s global sales channel to extend market reach. Dymax (Torrington, Conn.) manufactures rapid light-cure adhesives, conformal coatings, potting compounds and complementary dispensing and curing equipment used in medtech and… […]
Qosina releases 2022 catalog
Qosina said today it has released the latest edition of its product catalog in both print and digital formats. The 2022 product catalog includes thousands of single-use medical and pharma components depicted in full-scale photos on a one-centimeter grid to help design engineers visualize their next-generation medical device, according to the Ronkonkoma, N,.Y.-based company. Qosina… […]
Medline completes $1.5B spending plan
Medline Industries announced this week that it has completed a three-year, $1.5 billion capital spending campaign. The Northfield, Ill.-based company, which is reportedly up for sale, said it invested the money in new distribution centers, manufacturing capabilities and IT upgrades to improve customers’ e-commerce experience. All told, the initiative added approximately 8,500 new jobs, eight… […]
Clippard touts flow controller with high resolution and repeatability in a closed-loop system
Clippard recently announced the release of its Cordis flow controller, which uses a MEMS technology sensor upstream from a proportional valve. There’s also an option for a DR-2 regulator to provide accurate and precise pressure control in a small package. Said Clippard: “Unlike other mass flow controllers that require a 30-minute warm-up time, large differential… […]
FDA clears DBS targeting software
Surgical Information Sciences (SIS) recently won FDA clearance for software designed to guide deep-brain stimulation (DBS) procedures. The Plymouth, Minn.-based company’s software uses deep learning models to identify brain structures such as the subthalamic nuclei (STN) and globus pallidus internus/externus (GPi/GPe) commonly targeted for DBS procedures. The SIS system provides visualization of these structures for… […]
Cerapedics’ bone graft gains FDA breakthrough nod
Ortho-biologics company Cerapedics announced that it has won FDA breakthrough device designation for its investigational P-15L bone graft to treat degenerative disc disease (DDD). The company plans to enroll at least 270 DDD patients in the Aspire study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L… […]
FDA revokes Battelle mask decontamination EUA
The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April… […]
The importance of a valve’s soft start for critical applications requiring high precision
When a valve is cycled, one can observe the quality of control by measuring and graphing the flow leaving the valve and the input operating the valve, such as electrical current (for coil controlled valves) or steps (for stepper motor controlled valves). This paper will discuss the characteristics of a valve’s performance curve—specifically, where flow… […]
5 IP tips for medical device entrepreneurs
Taking certain steps — including some that are easily overlooked — can better protect your intellectual property. Thinking of designing your own medical device or launching a company? In recent DeviceTalks Weekly podcasts, two partners from the intellectual property law firm Finnegan, Henderson, Farabow, Garrett & Dunner, LLP shared several tips medical device company executives… […]