The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).

During a massive disaster or a pandemic, securing the necessary manufacturing capacity, needles, syringes, vials, properly labeled caps, reagents and other supplies is as critical as the development of the product itself. Some experts have been warning about these needs since COVID-19 first began spreading outside of China. Now members of Congress are sounding the alarm.

Westport, Conn.-based Lumendi LLC revealed that the first endoscopic appendectomy has taken place using its Dilumen Endolumenal Interventional Platform (EIP). The procedure represents a change from traditional appendectomies, which are performed through open or laparoscopic surgery, requiring an incision of the abdominal wall.

Security and safety, like beauty, are in the eye of the beholder, especially in the time of a politicized pandemic. “The U.S. drug supply chain is safe, and the supply chain is secure,” Judith McMeekin, associate commissioner for regulatory affairs at the FDA, testified before the Senate Finance Committee Tuesday.

The Kaiser Family Foundation (KFF) reported that 48% of U.S. adults surveyed had postponed medical care due to the COVID-19 pandemic. In good news, more than two-thirds of those who delayed care expected to get the care they have delayed over the next three months.

Boston Scientific Corp. reported the U.S. launch of its Directsense technology, a tool to aid electrophysiologists in measuring tissue response to radiofrequency (RF) waves during cardiac ablation procedures. Approved by the FDA in April, the technology is available on the company’s Rhythmia HDx mapping system.

PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark.

The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1

The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.

The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.