IMDA eNews 092623

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Innovative devices can help address inequities, says FDA

In its final guidance for its Breakthrough Devices Program, the FDA clarifies how the program applies to certain innovative medical devices that may help address inequities, aligning with the agency’s Strategic Priority to Advance Health Equity. Launched in 2015, Breakthrough Devices is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to speed up development, assessment, and review of devices for premarket approval, 510(k) clearance, and De Novo marketing authorization.

AARC award-winners

The American Association for Respiratory Care named eight members as SPOTY Recipients. (SPOTY stands for “Specialty Practitioner of the Year.”) Awards were presented to practitioners in adult acute care (Madison Fratzke), ambulatory and post-acute care (Kelly Long), diagnosis (Kenneth Harker), specialty practitioner of the year (J. Brady Scott), leadership and management (Fassil Getachew), neonatal/pediatrics (Khris O’Brien), sleep (Hayfa Shakkour-Perez), and surface and air transport (Michael Davis).

Breakthrough designation for spinal fusion device

Carlsmed (Carlsbad, California) announced that the FDA granted Breakthrough Device designation for the company’s aprevo® technology for treatment of patients with cervical spine disease. The one-of-a-kind lumbar fusion device is 3D-printed, sterile-packed and delivered directly to the hospital for surgery. Carlsmed expects to launch the technology in the United States in 2025.

Don Sizemore, Bill Carmouche to participate in AdvaMed Conference

IMDA President Bill Carmouche and Executive Director Don Sizemore will participate in a panel discussion about specialty distribution at the AdvaMed MedTech Conference in Anaheim, California, Oct. 9-11. AdvaMed has a division called AdvaMed Accel, with nearly 300 small and mid-sized medical device, diagnostic, and digital health company members. Accel is intended to provide members with opportunities for strategic networking and business development and provide a voice for startups and growth-stage companies on policy and advocacy issues impacting innovation in medical technology.

Non-physicians deliver one-fourth of U.S. health visits

Healthcare visits delivered by nurse practitioners and physician assistants in the U.S. are increasing rapidly and now account for a quarter of all healthcare visits, according to a study by researchers from the Department of Health Care Policy in the Blavatnik Institute at Harvard Medical School. The U.S. Bureau of Labor Statistics estimates that between 2019 and 2031, the number of nurse practitioners in the U.S. will increase by 80% and the number of physician assistants by nearly 50%. In contrast, the growth rate for physicians over the next decade or so is estimated at less than 5%.

Esophageal device gets De Novo designation

The FDA has granted Chicago-based Attune Medical De Novo marketing authorization for its esophageal heat transfer device (ensoETM). Attune Medical’s single-use silicone tube is inserted into the esophagus and acts as a thermal regulating device that cools the esophageal wall via a connected heat exchange unit. The closed-loop system gives surgeons the ability to proactively control temperature management. The De Novo designation 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

Keep your company protected against scammers

The FBI receives 300,000 email scam filings each year. Business scams are a large part of them. Is your company protected? Are your employees aware of the risk they can put your company in when receiving and sending emails? At the upcoming 2024 IMDA/HIRA Annual Conference and Manufacturers Forum, March 4-6, in Orlando, Florida, IMDA Executive Director Don Sizemore will show you how a common scam can cost you money. He should know, as his business was a victim of one. At the conference, learn how such scams work, how to spot them, and what to do once you are in the scam situation. Click here to register for the 2024 IMDA/HIRA Annual Conference and Manufacturers Forum