Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors. The company announced collaborations in the past that include […]
Drug-Device Combinations
Know Labs inks partnerships to accelerate progress toward FDA clearance for glucose monitor
Know Labs (NYSE:KNW) announced that it entered into a series of strategic partnerships as it looks to move toward a major regulatory nod. Seattle-based Know Labs develops the Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. This technology integrates into wearable, mobile or bench-top […]
Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR
Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing anesthesia in the operating room setting. Atlanta-based Vero Biotech designed Genosyl for inhaled nitric oxide (iNO) delivery. This approval covers the second-generation Genosyl device. The third-generation device — which recently received FDA approval — has not yet been tested with […]
How Embecta started strong and what’s ahead for the BD diabetes spinoff
Ten months after spinning off from BD, Embecta CEO Dev Kurdikar lays out what the future holds for the diabetes technology company. When Embecta became a standalone company in April 2022, CFO Jake Elguicze said he felt it was “uniquely positioned.” As a pure-play diabetes technology developer, its beginning phase hardly mirrors a normal startup. […]
Owen Mumford wins Pharmapack award for UniSafe auto-injector
Pharmapack Europe today announced that Owen Mumford Pharmaceutical Services received one of its 2023 Pharmapack Awards. The company received recognition in the “Drug Delivery Innovation” category for its UniSafe reusable, connected auto-injector. Woodstock, United Kingdom-based Owen Mumford designed UniSafe as a companion device for its UniSafe 1mL safety syringes. These devices deliver subcutaneous medication. UniSafe […]
Phillips-Medisize unveils new disposable injector pen
Phillips-Medisize, a Molex company, announced today that it expanded its product portfolio with a new disposable pen injector. Hudson, Wisconsin-based Phillips-Medisize designed the new injector for high-volume manufacturing. It intends to offer pharmaceutical companies a familiar, competitive pen injector for faster, more efficient and cost-effective market entry. The company plans to display the pen at […]
Aptar Pharma launches metal-free nasal spray pump
Aptar Pharma announced today that it launched its first metal-free, multidose nasal spray pump, called the APF Futurity. Crystal Lake, Illinois-based Aptar developed APF Futurity to deliver nasal saline and other comparable over-the-counter (OTC) formulations. The company designed the pump specifically for recyclability. It represents Aptar’s first “highly recyclable” nasal spray pump, according to a […]
Nemaura Medical garners U.S.-based purchase order for glucose sensors
Nemaura Medical (Nasdaq:NMRD) announced that it received a purchase order for 5,000 proBEAT glucose sensor subscriptions. HealthFleet, a U.S.-based telehealth provider, made the purchase order. It consists of 75,000 proBEAT glucose sensors over an initial five-month period. Nemaura values the deal at $500,000 in revenue, while HealthFleet possesses the option to increase volumes based on […]
Koru Medical Systems inks development deal on Freedom Infusion System with prefilled syringe
Koru Medical Systems (Nasdaq:KRMD) announced that it entered into a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The agreement aims to develop and seek regulatory approval for the Freedom Infusion System with an SCIg prefilled syringe. Koru said the agreement provides it the opportunity to develop an adaptation to the Freedom system. […]
Embecta opens new global headquarters in New Jersey
Embecta (Nasdaq:EMBC) announced today that it held a grand opening ceremony at its new global headquarters in New Jersey. The BD Diabetes business spinoff opened its new headquarters at 300 Kimball Drive, Suite 300, in Parsippany, New Jersey. The site houses members of the Embecta leadership team, global support functions and North American commercial organization. […]
