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Nancy Crotti

Retractable Technologies wins $27M federal contract

May 25, 2021 By Nancy Crotti

RTI-NEW-Logo-Retractable-Technologies

Retractable Technologies (NYSE:RVP) announced that it has received a government contract worth more than $27.3 million for its syringes. The new contract is the third multi-million-dollar deal that the U.S. Department of Health & Human Services (HHS) has awarded to the Little Elm, Texas-based company since February 2020. The company landed an $83.8 million contract with […]

Filed Under: Business/Financial News, Featured Tagged With: Retractable Technologies, U.S. Department of Health & Human Services

BD applicators cited in medical kit recall

May 24, 2021 By Nancy Crotti

BD ChloraPrep 3 mL applicator

A medical care kit company is recalling more than 8,200 kits because they contain BD applicators that may become contaminated with a fungus. The recall by Medical Action Industries covers certain of its 306 Medical Convenience Kits, distributed between December 12, 2019, and  March 22, 2021, according to the FDA. The agency has labeled the […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls Tagged With: BD, FDA, Medical Action Industries

Insulet sues Roche over diabetes tech patent

May 12, 2021 By Nancy Crotti

Insulet Roche

Insulet (NSDQ:PODD) is suing Roche Diabetes Care in the U.K., claiming that Roche prematurely began selling tubeless insulin pumps covered by an Insulet patent three years before that patent expires. The trial for the lawsuit, filed in August 2020, began this week in the U.K. High Court. Insulet claims that Roche has been infringing the […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Uncategorized

Ocular Therapeutix misses The Street on bottom-line leap

May 6, 2021 By Nancy Crotti

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) reported first-quarter results that missed the consensus forecast on Wall Street. The Bedford, Mass.–based eye disease therapeutic developer yesterday posted profits of $3.12 million, or $0.04 per share, on sales of $7.34 million for the three months ended March 31, 2021, for a bottom-line leap of 114% on sales growth of 181% […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Ocular Therapeutix

Lilly partners with four companies on insulin pen tech

May 6, 2021 By Nancy Crotti

Eli Lilly

Eli Lilly (NYSE:LLY) today announced deals with four companies whose diabetes management tech will work with Lilly’s latest insulin pen. The Tempo Pen is a modified version of Lilly’s existing prefilled, disposable insulin pen to which the Tempo Smart Button — in late-stage development – attaches. Through these new agreements, the Tempo Smart Button will […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Dexcom, Eli Lilly & Co., glooko, myDiabby Healthcare, Roche

BD’s Alaris pump hit with another serious recall

April 30, 2021 By Nancy Crotti

BD Alaris infusion pump

A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls Tagged With: Alaris, Avante Health Solutions, BD, FDA, Tenacore

BD applies to start shipping Alaris pumps again

April 26, 2021 By Nancy Crotti

BD Alaris infusion pump

BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system. BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March […]

Filed Under: Drug-Device Combinations, Featured, Hospital Care, Regulatory/Compliance Tagged With: BD, FDA

Medtronic must face pain-pump lawsuit

March 15, 2021 By Nancy Crotti

Medtronic SynchroMed II

A 70-year-old man may proceed with a lawsuit claiming that Medtronic’s SynchroMed II infusion pump is defective and that the company was negligent in manufacturing it. A U.S. District Court judge in West Virginia last week denied Medtronic’s motion to dismiss the lawsuit brought by John David Brumfield, who claims that the pump in the […]

Filed Under: Featured, Legal News, Pain Management Tagged With: Medtronic

Lilly to add Welldoc app to future insulin pen

February 25, 2021 By Nancy Crotti

Eli Lilly

Eli Lilly (NYSE:LLY) and Welldoc announced a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin pens, which are in development. Lilly and Welldoc will create a new version of Welldoc’s BlueStar insulin management software, which will integrate insulin dosing data for several Lilly insulins. The BlueStar app has FDA 510(k) clearance for […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance Tagged With: Eli Lilly & Co., elililly, welldoc

Biden’s COVID-19 response will make manufacturers busy

January 21, 2021 By Nancy Crotti

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, […]

Filed Under: Business/Financial News, Distribution, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: 3M, AdvaMed, Becton Dickinson, coronavirus, COVID-19, Defense Production Act, medical device manufacturers association (MDMA), vaccines

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