eNews April 27, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

Implant measures tissue oxygen levels

Engineers at the University of California, Berkeley, have created a wireless implant that can provide real-time measurements of tissue oxygen levels deep underneath the skin. The device, which is smaller than the average ladybug and powered by ultrasound waves, could help doctors monitor the health of transplanted organs or tissue and provide an early warning of potential transplant failure. This type of oxygen sensor differs from the pulse oximeters that are used to measure oxygen saturation in the blood. While pulse oximeters measure the proportion of hemoglobin in the blood that is oxygenated, this device directly measures the amount of oxygen in tissue. The technology is described in the journal Nature Biotechnology.

Don’t delay Medicare coverage of ‘breakthrough’ devices, manufacturers urge

Advamed has urged the Centers for Medicare & Medicaid Services to immediately implement a regulation that would offer Medicare beneficiaries automatic four-year reimbursement coverage for medical technologies authorized under FDA’s breakthrough device program, reports MedTech Dive. In response to CMS’ decision to postpone the final rule from taking effect until May 15, AdvaMed argued that additional delays in implementing the policy could compromise access to breakthrough technologies for beneficiaries who face life-threatening or debilitating conditions without other treatment options. But patient safety groups and doctors warn the rule goes too far and risks taking away the incentive to conduct clinical trials of the products.

Muscle rehabilitation for stroke patients

The FDA authorized marketing of a device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—disability. It uses non-invasive electroencephalography (EEG) electrodes instead of an implanted electrode or other invasive feature to record brain activity. The EEG data is wirelessly conveyed to a tablet for analysis of the intended muscle movement, and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand. The device aims to help stroke patients improve grasping.

Peripheral artery disease tool

Soundbite Medical Solutions (Montreal, Quebec) received FDA 510(k) clearance for the SoundBiteÒ Crossing System — Peripheral (SCS-P) with the 0.014” Active Wire (14P) — a recanalization tool designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in patients suffering from heavily calcified above-the-knee (ATK) and below-the-knee (BTK) peripheral artery disease (PAD). The company says the system will have a positive effect on the lives of patients with critical limb ischemia (CLI) and challenging calcified BTK disease.