eNews Aug 24, 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.

 

Software bill of materials: Legislation requested

The FDA is seeking legislation that would require medical technology manufacturers, as part of a premarket submission, to include a Software Bill of Materials and the capability to update and patch device security into a product’s design, reports MedTech Dive. In addition, the agency wants postmarket authority to require that manufacturers adopt policies and procedures for coordinated disclosure of cybersecurity vulnerabilities as they are identified. A software bill of materials is list of “ingredients” that make up software components.

Scope for sinus procedures cleared by FDA

Short Hills, New Jersey-based 3NT Medical announced FDA clearance for its Peregrine™ Drivable ENT Scope, said to allow ENT surgeons to access the farthest reaches of the sinuses to visualize anatomic landmarks. The scope is designed to enable the surgeon to angulate its 2.3mm tip sharply, and then advance it farther in the direction of the turn, all through single-hand operation. Peregrine can be used alongside the traditional 0° rigid endoscope, or as the main endoscope in the operating room.

Cybersecurity vulnerabilities identified in BlackBerry’s RTOS

The FDA says it is working with federal partners, medical device manufacturers and the private sector to address cybersecurity vulnerabilities with BlackBerry’s QNX Real Time Operating System (RTOS) version 6.5 Service Pack 1 and earlier. These vulnerabilities may introduce risks for certain medical devices, as well as pharmaceutical or medical device manufacturing equipment, though the FDA is not aware of any confirmed adverse events related to these vulnerabilities.

Breakthrough designation for temporary heart pump

Danvers, Massachusetts-based Abiomed received the FDA’s breakthrough device designation for the company’s Impella ECP expandable percutaneous heart pump, designed to provide temporary circulatory support and left ventricular unloading in patients undergoing a high-risk PCI, or percutaneous circulatory intervention. The device is said to be the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. It measures 9 French (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min.

Train your reps to compete on value

Dawson Cochran of ValueSelling Associates will train your sales reps to navigate the healthcare purchasing obstacle course with value-focused questioning at “ROI: It’s More Than Just Money,” the IMDA/HIRA Annual Conference in Itasca, Illinois, Sep. 27-29. Not a member? If you join IMDA within 90 days after Sept. 29, 2021, IMDA will deduct the non-member portion you paid from your first annual dues. That’s how sure we are that once you try us, you’ll like us. Click here for more information.