eNews Oct 19, 2021

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


Editor’s Note: This week’s eNews is intended to fill in some news gaps for IMDA members and medical device innovators, including FDA developments; digital health (a topic at the recent IMDA/HIRA Conference); the semiconductor shortage; and, of course, medical innovation.

Rapid test for concussion cleared by FDA

Boston-based SyncThink was granted FDA marketing clearance for its EYE-SYNC technology as an Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis. EYE-SYNC previously received Breakthrough Device Designation from the FDA in 2019, following the initial clearance and commercialization of the technology platform in 2017. It uses a series of 60-second eye tracking assessments, neurocognitive batteries, symptom inventories, and standardized patient inventories to identify the type and severity of dysfunction after concussion. The platform generates visual and vestibular therapies to remedy deficits and monitor improvement over time.


Health systems create digital healthcare company

SSM Health, Presbyterian Healthcare Services and Intermountain Healthcare launched Graphite Health, a company intended to spur development of digital health solutions. According to a press release, Graphite Health is creating a standardized, interoperable data platform that enables a secure and open marketplace to streamline the distribution of digital health solutions for health systems and entrepreneurs.

AARC names SPOTY recipients

Troy Whitacre, RRT, RRT-ACCS, University of Missouri Health Care, was named 2021 Specialty Practitioner of the Year in Adult Acute by the American Association for Respiratory Care as part of its 2021 SPOTY Recipients. Other recipients include: Katie Pennington, RRT, for ambulatory and post-acute care; Carl Hinkson, MSc, RRT, RRT-ACCS, RRT-NPS, FAARC, for leadership and management; and Anne M. Geistkemper, MSc, RRT, RRT-NPS, neonatal-pediatrics. Click here for a complete list of recipients.

A step forward for remote patient monitoring

In the latest Medicare Physician Fee Schedule, the U.S. Centers for Medicare and Medicaid Services proposed for the first time a set of CPT codes for remote therapeutic monitoring (RTM), reports Healthcare IT News. (The CPT code set is used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations.) The new RTM codes resemble those for remote physiological monitoring, which reimburses providers for the review of physiological data (e.g., heart rate) that is automatically transmitted from a device. The key difference between RPM and the new RTM codes is that RTM codes can specifically be used to monitor medication adherence.

Chip shortage hurting patients, medical industry

A shortage of semiconductor chips threatens millions of patients who depend on chip-powered equipment and devices including ventilators and defibrillators; imaging machines; glucose, ECG, EEG, and blood pressure monitors; implantable pacemakers; and more, according to Deloitte Consulting. The global market for chips is projected to grow from $452.2 billion in 2021 to $803.1 billion in 2028, but pandemic- and weather-related supply chain disruptions are causing critical shortages. Two-thirds of AdvaMed member companies surveyed by Deloitte have semiconductors and firmware/embedded software in over half of their products. In addition, 50 percent of respondents report that connected devices, which also require semiconductors, comprise half of their product portfolio.

Early feasibility studies: Back in the US

Certain sectors in U.S. medical technology development lag behind other countries because early feasibility studies (EFS) are done outside the U.S., says Liz Mino, PhD, who recently joined the Medical Device Innovation Consortium as program director of its EFS Initiative. Mino will oversee the expansion of MDIC’s EFS neurovascular and electrophysiology programs, and work to bring EFS trials back to the U.S. FDA defines an early feasibility study as a limited clinical investigation of a device early in development, which typically enrolls a small number of subjects, is used to evaluate the initial clinical safety and functionality of the device design concept, and may guide device modifications.

FDA clarifies process for novel medical devices

The FDA issued a final rule aimed at simplifying the De Novo classification process for medical devices, reports Medical Design & Outsourcing. In it, the agency established procedures and criteria for submitting and withdrawing a De Novo request while also setting guidelines for the FDA to decide on such a request. Per the FDA, the De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

Sepsis treatment gets innovator award

PATH EX, a medical technology startup that is developing an extracorporeal blood cleansing device (CycloPE) to selectively remove pathogens, including multi-drug-resistant bacteria and endotoxins from circulating blood, received the 2021 MedTech Innovator Execution Award during the AdvaMed Accel Leadership Seminar. “The company and its advisors are dedicated to advancing care in the sepsis space through innovation and are actively working to improve the lives of patients,” Paul Grand, CEO of MedTech Innovator.

Prototype co-ventilator developed

Three biomedical engineering graduates from the University of South Florida have developed a protype device – Eucovent – that allows two patients to be ventilated by a single machine. The team used dynamic resistance, which restricts the amount of airflow, and time multiplexing techniques to provide a customized co-ventilator. They used fabricated custom valves, which can be adjusted independently to meet each patient’s airflow needs. Additionally, they employed the digital signals technique of time multiplexing, which can alternate between patients and deliver breaths to each patient independently.

30-minute heart attack diagnosis

Researchers from the University of Notre Dame and the University of Florida have developed a sensor that could diagnose a heart attack in less than 30 minutes, according to a study published in Lab on a Chip. By targeting three distinct types of microRNA or miRNA, the sensor can distinguish between an acute heart attack and a reperfusion — the restoration of blood flow, or reperfusion injury, and requires less blood than traditional diagnostic methods to do so. The ability to differentiate between someone with inadequate blood supply to an organ and someone with a reperfusion injury is an unmet, clinical need that this sensor addresses.