Sep 20, 2024 · MedTech industry news. “Essentially, some patients are seeing delays in their scripts getting filled at certain U.S. retail pharmacies due to a low on-shelf inventory, and while there are likely some minor supply issues causing these script delays, demand also has been very strong as Abbott continues to gain share in the U.S.,” Marcus wrote on Thursday.

MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging, and more.

Dec 20, 2024 · Dive Insight: The FDA sent the warning letter in November after inspecting a BD facility in San Diego. Carefusion 303, a business that BD acquired in a $12.2 billion deal in 2015, makes devices including Pyxis at the facility. Carefusion, then part of Cardinal Health, entered into a still-active consent decree with the FDA in 2007 in relation to Alaris pumps.

Dec 19, 2024 · More recently, the FDA has taken actions to speed up public notices about recalls that it believes could be high risk. Under new Center for Devices and Radiological Health Director Michelle Tarver, the agency launched a pilot program in November and issued its first early alert on a Fresenius infusion pump recall this month.. Several heart devices have also come under scrutiny this year ...

Nov 15, 2024 · MedTech industry news. Dive Insight: Demand for viral vectors, which are used in the production of cell and gene therapies, outpaced supply in the late 2010s and into the 2020s as more candidates entered clinical development. Thermo Fisher and other contract development and manufacturing organizations responded by investing in production facilities.

Jun 20, 2024 · Dive Brief: Dermtech has filed for Chapter 11 bankruptcy protection and laid off 20% of its staff to support its push to find a buyer for its cancer test technology, the company said Tuesday.; The San Diego-based company, which makes a skin patch to test for melanoma, began looking for a buyer in January as a mix of reimbursement challenges and costs related to R&D, facility leases and more ...

Oct 23, 2024 · Dive Brief: The Food and Drug Administration cleared prior design modifications for iRhythm Technologies’ Zio AT wearable cardiac monitoring system in the first of two 510(k) submissions to the agency tied to ongoing remediation efforts.; Last year, the FDA issued a warning letter to iRhythm after finding issues during an inspection that included failing to seek clearance before making ...

Nov 21, 2024 · Dive Brief: Henry Schein said Wednesday it had agreed to acquire Acentus, a medical supplier specializing in delivering products to patients’ homes.; Henry Schein, a medical and dental supplies distributor, said the acquisition brings its homecare medical products platform’s annual revenue base to approximately $350 million.

Nov 22, 2024 · Dive Insight: Fortimedix has kept a low profile in recent years. The Dutch medtech company put out a series of press releases in 2016 and 2017, when it raised 11 million euros, received a CE mark and launched a single-port Symphonx surgery system in the U.S.. Physicians published a paper in 2020 about the learning curve for new users of the surgery system.

Oct 1, 2024 · J.P. Morgan Healthcare Conference. Jan. 13-16 San Francisco. The J.P. Morgan Healthcare Conference is one of the industry’s biggest events. Executives from medical device, hospital and pharmaceutical companies provide insights on their recent financial performance and developments to watch in the year ahead.