Medical devicemaker Exactech agreed to pay $8 million to settle allegations that it knowingly marketed and sold defective components within its line of Optetrak total knee systems, which have been cited in lawsuits as causing thousands of patient injuries, KFF…
Supply Chain
The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests over a four-year period. LDTs are tests designed,…
GSK plans to invest $30 billion on research, development and supply chain infrastructure in the U.S. over the next five years. The plan includes $1.2 billion for new manufacturing facilities and digital technologies, including a new biologics plant in Upper…
The FDA is warning consumers and healthcare providers not to rely on unauthorized blood pressure devices. Many of the devices sold over the counter lack FDA authorization, according to a Sept. 16 news release from the agency. Using such a…
The Republican-controlled House voted to grant President Donald Trump authority over tariffs through early 2026, with the aim of limiting Congress’ ability to challenge his trade actions, Politico reported Sept. 16. Republicans secured passage of the bill in a 213-211…
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Here are four of the latest recalls and corrections reported to the FDA.
Here are four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.
Vizient has recognized 22 suppliers and distributors with excellence awards for their contributions and collaboration with the organization and its members, according to a Sept. 15 news release. Vizient works with more than two-thirds of the nation’s acute care providers…
The FDA has issued a safety alert for several models of Boston Scientific’s Endotak Reliance defibrillation leads after identifying a serious defect linked to 16 deaths and 386 injuries. The leads, used in implantable defibrillators to deliver life-saving shocks during…
Medical devicemaker B. Braun SE has acquired True Digital Surgery, a company that develops robotic-assisted 3D surgical microscopes. The acquisition brings the company under B. Braun’s surgical division and aims to improve the devicemaker’s AEOS digital microscope system, which is…