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FDA

Smiths Medical recalls Medfusion 4000 due to issue with software update

December 19, 2019 By Sean Whooley

Smiths Medical

Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s […]

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

FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller

December 13, 2019 By Nancy Crotti

The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM)  t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: artificialpancreas, DexCom Inc., FDA, Tandem Diabetes Care

Senate confirms Dr. Stephen Hahn to lead FDA

December 12, 2019 By Nancy Crotti

The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s […]

Filed Under: Food & Drug Administration (FDA) Tagged With: AdvaMed, Dr. Stephen Hahn, FDA

Beta Bionics’ bionic pancreas wins breakthrough status from FDA

December 11, 2019 By Nancy Crotti

Beta Bionics - updated logo

The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device  — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Beta Bionics, FDA, Zealand Pharma

Tusker Medical’s pediatric ear tubes land breakthrough device designation

November 26, 2019 By Nancy Crotti

The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Research & Development Tagged With: FDA, Tusker Medical

Medtronic warns patients of MiniMed insulin pump safety issue

November 22, 2019 By Nancy Crotti

Medtronic Minimed 630g

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Recalls Tagged With: FDA, Medtronic, minimed

FDA approves expanded indication for Liletta 6-year IUD

October 28, 2019 By Sean Whooley

Allergan, Medicines360

Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Women's Health Tagged With: Allergan, FDA, Medicines360

Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin

October 28, 2019 By Sean Whooley

Insulet

Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: FDA, Insulet, Novo Nordisk

Aptar Pharma’s two-dose nasal spray device to deliver epinephrine

October 21, 2019 By Nancy Crotti

Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar’s Bidose (BDS) nasal device to deliver Bryn’s epinephrine nasal spray (BRYN-NDS1C). Crystal Lake, Ill.-based Aptar’s Bidose tech enables two-shot nasal drug delivery and will replace the need to carry two epinephrine auto-injectors, according to the companies. Last March, Aptar won FDA approval to […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: aptarpharma, Bryn Pharma, FDA

Clearside Biomedical confirms timeline for Xipere

October 21, 2019 By Sean Whooley

Clearside Biomedical logo - updated

Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]

Filed Under: Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Clearside Biomedical, FDA

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