eNews March 30, 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.

Helmet noninvasive ventilation is studied

Among critically ill patients with moderate to severe hypoxemic respiratory failure due to COVID-19, helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. The results of a randomized trial, which included 109 patients, found the median number of days free of respiratory support within 28 days was 20 days in the group that received helmet noninvasive ventilation and 18 days in the group that received high-flow nasal oxygen, a difference that was not statistically significant.

Great technology. But what about profit?

What if you invent a breakthrough device that can improve health outcomes – but you can’t make any money from it? After Medicare rates for long-term cardiac monitoring were slashed in April, the overall cardiac wearables market, including iRhythm Technologies, will likely feel the pinch, reports MedTech Dive. In January, a regional Medicare Administrative Contractor (MAC) cut reimbursement rates for extended external EKG use from roughly $310 to a range of about $40 to $50. The move came after Medicare failed to set a national price for home monitoring services, leaving the decision to the MACs. The U.S. cardiac monitoring market is worth about $2 billion and is currently 20% penetrated, according to William Blair.

Health system is technology innovator

Advocate Aurora Health, a 26-hospital system in northern Illinois and southern Wisconsin, has launched Advocate Aurora Enterprises, a subsidiary focused on investing in businesses designed to enable people to improve their health and wellbeing beyond traditional clinical care settings. Its first investment: Chicago-based Foodsmart, which provides several services through its platform, including telenutrition meetings with registered dietitians, personalization of meal plans and grocery lists, and the ability to order food online.

Shoulder system gets FDA clearance

Catalyst OrthoScience Inc., a Naples, Florida-based company focused on the upper extremity orthopedics market, has received clearance from the U.S. Food & Drug Administration to market its reverse shoulder system, designed for patients experiencing severe shoulder arthritis in conjunction with a grossly deficient or non-functional rotator cuff. In a reverse shoulder system, the design is inverted compared to a traditional anatomic total shoulder prosthesis where the articulating sphere is on the glenoid side of the joint and the mating insert is fixed into the humeral stem implant. Reverse shoulder arthroplasty is estimated to encompass more than 60 percent of the shoulder arthroplasty market, according to the company.

Microrobots deliver payload for central nervous system disorders

Los Angeles-based Bionaut Labs received $20 million in financial backing for its Bionaut™ treatment modality, which uses remote-controlled microscale robots to deliver biologics, nucleic acids or small molecular therapies locally to targeted central-nervous-system disease areas. Smaller than a millimeter, the “robots” contain moving parts controlled remotely by a magnetic controller, allowing them to safely reach the target and release a therapeutic payload.

‘Breakthrough’ device powered by artificial intelligence

Chicago-based Tempus Inc. received FDA “breakthrough device” designation for its ECG Analysis Platform, an artificial-intelligence (AI)-powered platform that helps clinicians identify patients at increased risk of developing atrial fibrillation (AF) or atrial flutter. Intended for use with patients 40 and older, twhe device analyzes the results of a 12-lead electrocardiogram (ECG) to provide insights into a patient’s future risk of AF or atrial flutter. Tempus developed the technology in collaboration with Geisinger, the Danville, Pennsylvania-based health system. Breakthrough Device designation expedites the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Short-term treatment of gait deficit

The FDA authorized marketing of a device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device, called Portable Neuromodulation Stimulator (PoNS), developed by Helius Medical, is a neuromuscular tongue stimulator that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to provide treatment of motor deficits. Breakthrough Device designation is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.