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Sean Whooley

Convatec, Beta Bionics partner on iLet bionic pancreas

May 25, 2023 By Sean Whooley

Beta Bionics iLet Dexcom G6 Convatec infusion set

Convatec announced that it partnered with Beta Bionics on the launch of the iLet Bionic Pancreas for automated insulin delivery. FDA last week cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. Convatec offers design and manufacturing services for infusion set technologies and insertion devices for insulin pump treatment. Beta […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Beta Bionics, Convatec

Medtronic to acquire wearable insulin patch maker EOFlow for $738M

May 25, 2023 By Sean Whooley

EOFlow EOPatch insulin patch

Medtronic (NYSE:MDT) announced today that it entered into a set of agreements to acquire insulin delivery technology developer EOFlow. Seongnam, South Korea-based EOFlow develops the EOPatch — a tubeless, wearable and fully disposable insulin delivery device. EOFlow already launched its EOPatch insulin delivery system in Korea and Europe. The company submitted the insulin delivery device […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Mergers & Acquisitions, Patient Monitoring, Technology Tagged With: eoflow, Medtronic

ClearPoint Neuro enters drug delivery licensing deal with UCB

May 24, 2023 By Sean Whooley

Clearpoint Neuro logo (1)

ClearPoint Neuro (Nasdaq:CLPT) announced today that it entered into a multi-year license agreement with UCB over gene therapy delivery. Solana Beach, California-based ClearPoint Neuro develops a therapy-enabling platform providing navigation and delivery to the brain. The licensing agreement with UCB establishes a partnership on delivery platforms for UCB’s gene therapy portfolio. “We are extremely excited […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Neurological Tagged With: ClearPoint Neuro, UCB

Aerami presents positive data for inhaled pulmonary hypertension treatment

May 24, 2023 By Sean Whooley

aerami-therapeutics

Aerami Therapeutics today announced positive data supporting its inhaled imatinib for treating pulmonary hypertension (PH). Studies of AER-901 support progression into a Phase 2 clinical trial. Data backed Aerami’s treatment for both PH associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination. Aerami designed it to deliver potentially […]

Filed Under: Business/Financial News, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: Aerami Therapeutics

ICU Medical recalls certain infusion pump replacement batteries

May 23, 2023 By Sean Whooley

ICU Medical Plum 360 infusion system

The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, ICU Medical

FDA approves another nasal spray for treating opioid overdose

May 23, 2023 By Sean Whooley

Opiant Pharmaceuticals Indivior FDA Opvee opioid overdose nasal spray

The FDA approved Opvee nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdoses from Opiant Pharmaceuticals. Approval covers the treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This market the first such authorization for this type of spray in healthcare and community use. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: indivior, opiantpharmaceuticals

BD expands availability of all-in-one flush pre-filled syringe

May 23, 2023 By Sean Whooley

BD PosiFlush SafeScrub Syringe

BD (NYSE:BDX) announced today that it expanded customer availability for its all-in-one pre-filled flush syringe. Franklin Lakes, New Jersey-based BD designed its PosiFlush SafeScrub syringe with an integrated disinfection unit. It reinforces compliance with infection prevention guidelines, simplifying nursing workflow. BD built the active disinfection unit right into the tip cap of the PosiFlush SafeScrub […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured Tagged With: BD

FDA clears automated insulin pump from Beta Bionics for type 1 diabetes

May 19, 2023 By Sean Whooley

Beta Bionics - updated logo

The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Beta Bionics, FDA

Study supports smart blood glucose meter from LifeScan

May 18, 2023 By Sean Whooley

LifeScan OneTouch app

LifeScan today announced positive data from a study of real-world evidence supporting its Bluetooth-connected blood glucose meter. Evidence from more than 55,000 people with diabetes demonstrated sustained improvements in readings in range. The analysis focuses on changes over 180 days. LifeScan published results in the peer-reviewed journal Diabetes Therapy. The company’s OneTouch Bluetooth-connected blood glucose […]

Filed Under: Clinical Trials, Diabetes, Featured, Patient Monitoring, Technology Tagged With: lifescan

Schott Pharma launches pre-filled polymer syringes for deep-cold drugs

May 17, 2023 By Sean Whooley

Schott Pharma Toppac Freeze pre-filled syringe

Schott Pharma announced today that it launched pre-fillable syringes made from advanced polymers for delivering deep-cold drugs. These deep-cold drugs are stored and transported on dry ice at temperatures reaching -100°C. Schott designed the syringes from an advanced, pharmaceutical-grade polymer, delivered in a standardized nest and tub configuration. This ensures compatibility on major fill-finish lines […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Schott Pharma

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