Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
AliveCor
AliveCor names new CFO
AliveCor this week said it has appointed Clyde Hosein as chief financial officer. Hosein has more than 30 years of leadership experience in corporate financial management. He previously served as CFO at RingCentral and Marvell Technology. He most recently was CFO at Automation Anywhere. “We are building a global enterprise platform to make heart care […]
Alivecor wins FDA clearance for next-gen interpretive ECG algorithms
AI-based electrocardiogram (ECG) technology developer AliveCor announced that it received FDA clearance for its next-gen ECG algorithms. Mountain View, Calif.-based AliveCor’s next-gen interpretive ECG algorithms, called Kardia AI V2, offers users a way to take a 30-second ECG and receive instant determinations of multiple cardiac conditions through the company’s KardiaMobile and KardiaMobile 6L devices and the […]
AliveCor closes $65M Series E
AI-based electrocardiogram (ECG) technology developer AliveCor announced today that it has closed a $65 million Series E financing round. Mountain View, Calif.-based AliveCor plans to use proceeds from the financing round to accelerate the growth of its remote cardiology platform, both domestically and globally, according to a news release. AliveCor is augmenting its artificial intelligence-powered […]
DTW Podcast: New tools helping medtechs overcome COVID19 challenges
In this week’s DeviceTalks Weekly Podcast, senior executives from Avail Medsystems and AliveCor detail how their tools are helping medtechs remain in contact with both physicians and patients. In the keynote interview with Daniel Hawkins, CEO of Avail Medsystems, says the company’s Procedural Telemedicine system will allow medical device sales representatives to observe more procedures […]
FDA allows use of AliveCor’s Kardia device for COVID-19 patients
AliveCor announced that the FDA now allows the company’s KardiaMobile 6L electrocardiogram (ECG) for use in measuring QTc (a heart rhythm disorder that can potentially cause fast, chaotic heartbeats) in patients with COVID-19. The Mountain View, Calif.-based company touts its KardiaMobile 6L as the world’s only six-lead personal ECG. It is designed to detect potentially […]
AliveCor inks wearables deal with Huami
AliveCor said yesterday that it entered into a strategic partnership with Huami Corp. (NYSE:HMI) to combine each company’s technologies for developing medically functional wearable devices. The financial details of the agreement were not disclosed but the company said the agreement includes the licensing of AliveCor technology and a deal to bring new devices and services to […]
AliveCor raises $6m for mobile ECG devices
AliveCor said it raised nearly $6 million in equity financing for its mobile electrocardiogram devices. The Mountain View, Calif.-based company said nine investors put up a collective $5.8 million toward its $9.2 million goal. The first sale was Oct. 15, according to the filing. AliveCor makes the KardiaBand, a wrist-worn device that is designed to […]
AliveCor stops selling KardiaBand ECG for Apple Watch
AliveCor reportedly yesterday said that it ended sales of its KardiaBand for use with the Apple Watch. The company stopped selling the device in June and has pulled the device from its Amazon vendor profile as well, according to MobiHealthNews. “In 2017, we were proud to launch the first FDA-cleared accessory for the Apple Watch,” […]
Ex-Medtronic CFO Ellis joins Inspire Medical board | Personnel Moves, August 2, 2019
Inspire Medical Systems last week named Gary Ellis, the former CFO at Medtronic (NYSE:MDT), to its board of directors effective immediately. Minneapolis-based Inspire Medical also said that Amzak Health managing partner Joyce Erony left the board effective yesterday. Ellis spent 27 years at Medtronic before retiring in 2016. “On behalf of the entire Inspire board […]
Best Buy to retail AliveCor’s KardiaMobile
AliveCor said yesterday that it has inked a strategic partnership deal with Best Buy to offer its KardiaMobile electrocardiogram devices at their retail locations across the U.S. The Mountain View, Calif.-based company’s KardiaBand is a wrist-worn electrocardiogram device designed to detect atrial fibrillation and normal sinus rhythm. AliveCor said that the deal marks the first time […]
