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.
Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications. While anticoagulant medications can reduce that risk, patients need careful monitoring to ensure their blood is neither too thick nor too thin. To that end, Los Angeles-based startup Neural Analytics Inc. is deploying its robotically assisted transcranial doppler (TCD) system for real-time identification of blood clots and disruptions in blood flow to the brain.
Like many companies, Rewalk Robotics Ltd. saw its financials hit by the COVID-19 pandemic. It revealed May 28 that its total revenue for its first quarter fell to $0.8 million, down from $1.6 million during the same period last year. The company, which focuses on solutions that give gait training and mobility for individuals with lower limb disabilities, acknowledged the effects of the pandemic, noting that several Rewalk Personal 6.0 devices were not delivered as a result.
TORONTO – Vancouver, British Columbia-based Izotropic Corp. has inked a deal with Victoria, British Columbia-based based Starfish Medical Inc. to commercialize a CT scanner Izotropic CEO Robert Thast said will be a major disruptor of the breast imaging industry. Izotropic has spent approximately $20 million over the past 15 years to develop the system and is counting on Starfish to help translate this into a market-ready 3D breast CT imager by the end of 2020.
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