eNews February 23, 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.

2020: A good year for novel devices

A record-high 132 novel medical devices were approved, cleared or authorized by the U.S. Food and Drug Administration in 2020, surpassing the 40-year high mark the agency set in 2018. It is a big leap from the 29 novel devices authorized in 2010, said Jeff Shuren, MD., director of the Center for Devices and Radiological Health. Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE), and De Novo pathways, as well as a subset of those that are brought to market with 510(k) clearance or Emergency Use Authorization (EUA). The year’s novel devices include an anterior cruciate ligament implant as an alternative to ACL reconstruction, the first cardiac ultrasound software that uses artificial intelligence to guide the user to capture quality diagnostic images, and the first continuous renal replacement therapy device for a lower-weight pediatric population with sudden or temporary loss of kidney function or fluid overload.

3D-printed ankle implant

The FDA approved Additive Orthopaedics’ Patient Specific Talus Spacer, a 3D-printed talus implant for humanitarian use. The Patient Specific Talus Spacer is said to be the first-of-its-kind implant to replace the talus—the bone in the ankle joint that connects the leg and the foot—for the treatment of avascular necrosis (AVN) of the ankle joint, a serious and progressive condition that causes the death of bone tissue stemming from a lack of blood supply to the area. The implant provides a joint-sparing alternative to other surgical interventions commonly used in late-stage AVN, which may disable motion of the ankle joint. A Humanitarian Use Device is one that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.

Google, Mayo moving in together

Google announced it would open a permanent office in Mayo Clinic’s hometown of Rochester, Minnesota, signaling a deepening of the relationship between the two organizations, reports HealthLeaders. Two divisions of the company will occupy the space, including Google Cloud and Google Health, and most of those working there will be specialists in software engineering and artificial intelligence. Since beginning to work together, Google and Mayo have accomplished a number of things, including development of an “AI factory,” intended to enable innovators to progress from idea to breakthrough more quickly than they could in the past. In addition, the collaborators have been involved in an AI-machine learning initiative to improve the speed, accuracy, and quality of delivering radiotherapy to cancer patients, along with reducing the cost.

Standard for artificial intelligence

A working group of health technology companies and healthcare organizations have released a new standard for artificial intelligence in healthcare. The Consumer Technology Association, which created the group, says the standard identifies the core requirements and baseline for AI solutions in healthcare to be deemed as trustworthy. Additionally, it explores the impact of the trustworthiness of AI in healthcare through the lens of the end user (e.g., physician, consumer, professional and family caregiver, public health, medical societies, and regulators) and will identify the challenges and opportunities for AI in the healthcare sector.