eNews February 9, 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.

Is there a cybersecurity expert at the table?

Medical devices today need meaningful cybersecurity at their earliest design stage, says Kevin Fu, who was appointed to the newly created position of acting director of medical device security with the FDA. “There are so many different constituencies needed in the early design stage,” said Fu, in an interview published by the University of Michigan, where he serves as associate professor of electrical engineering and computer science. “You have legal experts, engineers, patients, clinicians, and often, there simply isn’t a software security expert at the table. Yet today, medical devices rely on extremely complicated software systems that do not necessarily follow the fundamental principles of information security and privacy we teach at the University of Michigan. When security experts are brought in late in the game, the design vulnerabilities are already baked into the devices. You can’t simply sprinkle magic security pixie dust after designing a device.”

Transport and emergency ventilators

Israeli-based Inovytec received FDA 510(k) clearance for its Ventway Sparrow ventilators. The 2.2-lb. transport and emergency ventilators are said to allow for both invasive and noninvasive ventilation for patients weighing above 5 kg. (11 lb.). A built-in turbine removes the dependency from external oxygen supply and serves as a cooling system, while an optional mode allows for ventilation to start within five seconds. An internal battery provides up to 4.5 hours of operation. Last month, the company signed a deal to supply 1,500 units to Global Medical Supply, a California-based distributor which was awarded a supply agreement with the state of California.

‘Breakthrough Device’ designation for transcatheter technology

Alleviant Medical Inc. of Austin, Texas, received a Breakthrough Device designation from the FDA for its transcatheter technology, designed to offer a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF). The Breakthrough Device Program is intended to expedite the development, assessment and review of innovative medical devices while preserving the statutory standards for premarket approval. A new coverage pathway for Breakthrough Devices — the Medicare Coverage of Innovative Technology (MCIT) –provides up to four years of Medicare coverage beginning on the date that FDA clears or approves a Breakthrough Device.

Treat sleep apnea while awake

Signifier Medical Technologies, Needham, Massachusetts, was granted FDA clearance to market a prescription-only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, the eXciteOSA is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep. The device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state, for a period of six weeks, and once a week thereafter.