Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app. San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release. The Fitbit […]
Health Technology
Theranica lands CE mark for migraine device
Theranica announced today that it received CE Mark approval for its Nerivio device for the acute treatment of migraine. Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. The approval allows for the company to begin marketing the device in […]
The top 5 MassDevice stories of the week — September 4, 2020
Medtronic (NYSE:MDT) and a major development involving medtech reimbursement dominated medical device industry news over the past week. As the week closes out, there’s also a trending story on MassDevice that includes good news: Abbott (NYSE:ABT) is reportedly hiring 2,000 new employees in Illinois to increase manufacturing for its rapid COVID-19 test. Want to hear more about […]
FDA authorizes mobile COVID-19 test kit
The FDA has issued emergency use authorization (EUA) for a mobile COVID-19 test kit developed by handheld detection system maker DetectaChem. Stafford, Texas-based DetectaChem develops the MobileDetect Bio BCC19 test kit is designed to test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal swabs, mid-turbinate nasal swabs and oropharyngeal swab specimens. […]
Smith & Nephew is using vibrating bracelets to encourage social distancing
Smith & Nephew (NYSE:SNN) is utilizing devices made by Tharsus to help with social distancing as the company returns to the office. A report in The Telegraph outlines how the London-based medtech company is being providing vibrating bracelets from Blythe, England-based Tharsus to keep the six-foot (two-meter) distance widely recommended for preventing the spread of COVID-19. Get the full story […]
IBM uncovers software vulnerability that could affect insulin pumps
A team of IBM security researchers uncovered a potential vulnerability in software from Thales that could affect insulin pumps. IBM’s “X-Force Red” team discovered the internet of things (IoT) vulnerability that can be remotely exploited in September 2019 with Thales’ Cinterion EHS8 M2M module, according to a report from SecurityIntelligence. The software is used in […]
DTW Podcast: Truist’s Kaila Krum says Medtronic prepping for growth
In an interview with DeviceTalks Weekly Podcast, Truist Securities managing director Kaila Krum says Medtronic executives are retooling the company to keep pace with smaller, more focused competitors. Breaking down the company’s Q1 call, Krum says Medtronic is seen as a company that’s too big to grow market share quickly. On the call, new CEO […]
Philips, Google, ResMed among companies joining digital therapeutics standards initiative
Major companies in the medtech space — including Philips, Google and ResMed — are among those joining the Consumer Technology Association’s new digital therapeutics standards initiative. “With the COVID-19 pandemic, we are seeing faster innovation across all aspects of digital health including digital therapeutics,” said Gary Shapiro, CEO of the CTA. “This field takes the […]
Smith+Nephew Launches Aria care management platform
Smith & Nephew (NYSE:SNN) announced today that it launched its ARIA digital platform for connecting patient care delivery with providers. Aria is designed to help clinicians shorten a patient’s post-acute recovery time, develop efficiencies that reduce costs and generate key patient-reported outcome measures, according to a news release. London-based Smith & Nephew’s platform is powered by […]
This telemedicine system could get medtech sales reps back to ORs
Daniel Hawkins’ surprise isn’t a matter of what, but when. The successful medtech executive and former Shockwave Medical CEO fully expected medical device makers would see Avail Medsystem’s telemedicine system as a more efficient way for sales reps to sit in on surgeries. By Hawkins’ projections, Avail’s system would eliminate much of the time sales […]
The top digital health startups in the world
About two-fifths of the startups in CB Insights’ second annual Digital Health 150 list are engaged in telehealth, a high-demand area amid the COVID-19 pandemic. That is one of the big takeaways from the list of 150 promising digital health startups that CB Insights released today. CB Insights’ research team picked the 150 startups after […]