FDA in the U.S. is setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, which raise potential manufacturing process problems. FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017. The proposed process […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
More device shortages pegged to sterilization plant shutdown
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
EO plant shutdown leads to pediatric breathing tube shortage
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
FDA warns against unapproved concussion diagnosis devices
The FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians. “The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without […]
Orthofix Medical touts data from artificial disc study
A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today. Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]
ReShape taps Allergan vet Bandy for CEO | Personnel Moves, April 3 2019
ReShape Lifesciences (NSDQ:RSLS) said last week that it named Allergan (NYSE: AGN) veteran Barton Bandy to replace Dan Gladney in the corner office, effective April 1. Gladney, who announced his retirement in January, is staying on as chairman. Bandy spent a decade at Inamed until its $3.2 billion purchase by Allergan in 2005. “I am […]
FDA wants public input on AI-enabled device regulation
The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared. It is also asking for the public’s feedback. To date, […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
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